Traumatic Amputation of Arm
Conditions
Keywords
Amputation, Prosthetic Design, Upper Extremity
Brief summary
The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage. All participating subjects will enroll in Part A of the study which will involve supervised training. Eligible subjects will be invited to participate in Part B, the home use portion of the study.
Detailed description
The specific objectives of this study are to: 1. identify and describe upper limb amputees who would be appropriate candidates for home use of this advanced prosthesis as well as those who would not be appropriate. 2. Compare the extent of use of the existing prosthesis to that of the DEKA Arm.and quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life. 3. Compare the outcomes of users of pattern recognition to the outcomes of users without 4. quantify the amount and type of technical support and repairs needed during the study, and estimate the number of home study days lost due to service/repair. All participating subjects will enroll in Part A of the study, which will involve supervised, in-laboratory training, as well as supervised community based outings. Based upon the findings from Part A, study staff will classify participants as appropriate or not appropriate for participation in Part B (the home usage portion of the study). Final determination of appropriateness for home use will be made after a home visit. The home use portion of the study will last for 13 weeks and involve regularly scheduled study visits. Measures of existing prosthetic activity will be compared with those of home use of the advanced upper limb prosthetic device to determine the extent of adoption. Changes in device satisfaction, performance of functional activities, and quality of life will be evaluated throughout the study. Data on technical support usage will also be gathered.
Interventions
DEVICEAdvanced upper limb prosthetic device IMU controlled
Advanced upper limb prosthetic IMU controlled
DEVICEAdvanced upper limb prosthetic EMG-PR controlled
Advanced upper limb prosthetic EMG-PR controlled
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential testing in non-equivalent comparison groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria (Parts A and B): * All subjects must be at least 18 years old and have single or bilateral upper limb amputation. * Subjects must be able to understand the requirements of the study and sign an Informed Consent Form and HIPAA Authorization Form. * Subjects will include those who are current users of any type of prosthetic device (body powered, electric or hybrid), non-users of devices who have been previously fit with a device, but have chosen not to wear it, as well as new users of devices. * To participate in the study all subjects must have active control over one or both ankles, OR have an appropriate number of myoelectric and/or other control sites (as determined by the Principal Investigator in conjunction with the research team) to allow adequate prosthetic controls configuration. Inclusion Criteria Part B only: * Completion of all Part A study activities. * Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) Scale | baseline and after 9-12 weeks of home use (end of Part B) | The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used. |
| Activities Measure for Upper Limb Amputees (AM-ULA) | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | The AM-ULA is an 18-item measure assessing functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10 and has a range from 0 (lowest functional performance) to 40 (highest functional performance). |
| Three Scales of the Veterans Version of the SF-36 | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life. |
| Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5) cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second. |
| Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion of activities performed using a prosthesis. |
| Timed Measure of Activity Performance (T-MAP) | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance |
| Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods and ranged from 0 to 100 with lower scores reflecting better function. |
| The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration. |
| University of New Brunswick Test of Prosthetic Function (UNB) | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. Each task was rated for both spontaneity and skill. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick & smooth). Summary scores are calculated for each subscale by averaging items and range from 0 to 4 with higher scores reflecting higher spontaneity and skill. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled | 39 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled | 13 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Home Use (Part B) | Withdrawal by staff | 0 | 1 |
| Home Use (Part B) | Withdrawal by Subject | 6 | 0 |
| In-laboratory (Part A) | Lost to Follow-up | 2 | 1 |
| In-laboratory (Part A) | Scheduling conflict | 2 | 1 |
| In-laboratory (Part A) | Withdrawal by Subject | 2 | 0 |
| Screened for Part B Eligibility | Declined participation | 8 | 1 |
| Screened for Part B Eligibility | Deemed ineligible by staff | 1 | 2 |
Baseline characteristics
| Characteristic | Advanced Upper Limb Prosthetic Device IMU Controlled | Advanced Upper Limb Prosthetic EMG-PR Controlled | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 2 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 11 Participants | 43 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 16.1 | 46.1 years STANDARD_DEVIATION 15.4 | 45.8 years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 12 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 31 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 34 Participants | 11 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 13 |
| other Total, other adverse events | 5 / 39 | 1 / 13 |
| serious Total, serious adverse events | 0 / 39 | 0 / 13 |
Outcome results
Primary
Change in Quality of Life (QOL) Scale
The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B.
Time frame: baseline and after 9-12 weeks of home use (end of Part B)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Change in Quality of Life (QOL) Scale | 5.8 score on a scale | Standard Deviation 0.7 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Change in Quality of Life (QOL) Scale | 5.3 score on a scale | Standard Deviation 0.6 |
p-value: 0.935895% CI: [-0.27, 0.28]t-test, 2 sided
Comparison: Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.0895% CI: [-1.47, 0.09]Regression, Linear
Secondary
Activities Measure for Upper Limb Amputees (AM-ULA)
The AM-ULA is an 18-item measure assessing functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10 and has a range from 0 (lowest functional performance) to 40 (highest functional performance).
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Prosthesis users only, at baseline, completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Prosthesis users at baseline | 17.5 units on a scale | Standard Deviation 6.1 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Completers End of Part A | 16.8 units on a scale | Standard Deviation 4.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Completers End of B | 10.7 units on a scale | Standard Deviation 4.4 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Prosthesis users at baseline | 10.4 units on a scale | Standard Deviation 3.3 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Completers End of Part A | 16.8 units on a scale | Standard Deviation 3.1 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Activities Measure for Upper Limb Amputees (AM-ULA) | Completers End of B | 19.8 units on a scale | Standard Deviation 1.8 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).p-value: 0.336795% CI: [-2.99, 1.05]t-test, 2 sided
Comparison: Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.633995% CI: [-3.84, 2.39]Regression, Linear
Secondary
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5) cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Prosthesis users only, at baseline, completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Completers End of B | 0.28 items completed per second | Standard Deviation 0.15 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: : Completers at End of Part A | 0.05 items completed per second | Standard Deviation 0.04 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Lifting Small Items:: Completers End of Part | 0.07 items completed per second | Standard Deviation 0.07 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Completers End of Part A | 0.07 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Completers End of B | 0.45 items completed per second | Standard Deviation 0.19 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: Prosthesis users at baseline | 0.09 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: Completers End of B | 0.10 items completed per second | Standard Deviation 0.07 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Small Items: Prosthesis users at baseline | 0.08 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Prosthesis users at baseline | 0.37 items completed per second | Standard Deviation 0.24 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Completers at End of Part A | 0.35 items completed per second | Standard Deviation 0.18 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Lifting Small Items: Completers End of B | 0.08 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Prosthesis users at baseline | 0.12 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Completers End of B | 0.09 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Prosthesis users at baseline | 0.11 items completed per second | Standard Deviation 0.09 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Completers End of Part A | 0.07 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Completers End of B | 0.10 items completed per second | Standard Deviation 0.07 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Prosthesis users at baseline | 0.21 items completed per second | Standard Deviation 0.15 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Completers End of Part A | 0.19 items completed per second | Standard Deviation 0.15 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Completers End of B | 0.24 items completed per second | Standard Deviation 0.16 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Prosthesis users at baseline | 0.24 items completed per second | Standard Deviation 0.17 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Completers End of Part A | 0.20 items completed per second | Standard Deviation 0.15 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Completers End of B | 0.14 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: Prosthesis users at baseline | 0.10 items completed per second | Standard Deviation 0.03 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Prosthesis users at baseline | 0.12 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Completers End of Part A | 0.06 items completed per second | Standard Deviation 0.05 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Prosthesis users at baseline | 0.22 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Completers End of Part A | 0.13 items completed per second | Standard Deviation 0.09 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Completers End of B | 0.16 items completed per second | Standard Deviation 0.07 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Checkers: Completers End of B | 0.11 items completed per second | Standard Deviation 0.04 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Completers End of B | 0.42 items completed per second | Standard Deviation 0.16 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Completers at End of Part A | 0.39 items completed per second | Standard Deviation 0.12 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: : Completers at End of Part A | 0.06 items completed per second | Standard Deviation 0.03 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Prosthesis users at baseline | 0.12 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Page Turning: Completers End of B | 0.07 items completed per second | Standard Deviation 0.03 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Light Cans: Completers End of Part A | 0.10 items completed per second | Standard Deviation 0.08 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Lifting Small Items: Completers End of B | 0.06 items completed per second | Standard Deviation 0.06 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Completers End of Part A | 0.05 items completed per second | Standard Deviation 0.05 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Prosthesis users at baseline | 0.37 items completed per second | Standard Deviation 0.17 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Heavy Cans: Prosthesis users at baseline | 0.24 items completed per second | Standard Deviation 0.11 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Lifting Small Items:: Completers End of Part | 0.04 items completed per second | Standard Deviation 0.03 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Feeding: Completers End of B | 0.05 items completed per second | Standard Deviation 0.03 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Small Items: Prosthesis users at baseline | 0.07 items completed per second | Standard Deviation 0.06 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).p-value: 0.669195% CI: [-0.05, 0.07]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).p-value: 0.051195% CI: [-0.05, 0]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).p-value: 0.594295% CI: [-0.02, 0.04]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).p-value: 0.010195% CI: [-0.07, -0.01]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).p-value: 0.106395% CI: [-0.06, 0.01]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).p-value: 0.247495% CI: [-0.06, 0.01]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).p-value: 0.160495% CI: [-0.09, 0.02]t-test, 2 sided
Comparison: Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.420895% CI: [-0.12, 0.09]Regression, Linear
Comparison: Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.195995% CI: [-0.09, 0.02]Regression, Linear
p-value: 0.332895% CI: [-0.09, 0.03]Regression, Linear
Comparison: Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.658595% CI: [-0.05, 0.08]Regression, Linear
p-value: 0.055295% CI: [-0.12, 0]Regression, Linear
Comparison: Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.031995% CI: [-0.25, -0.01]Regression, Linear
Comparison: Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.007395% CI: [-0.24, -0.04]Regression, Linear
Secondary
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Baseline participants and completers at End of A and End of B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived: Completers End of Part A | 53.5 score on a scale | Standard Deviation 12.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived: Completers End of Part B | 59.5 score on a scale | Standard Deviation 17.1 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent of Participation: Baseline | 53.8 score on a scale | Standard Deviation 8.1 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent: Completers End of Part A | 54.4 score on a scale | Standard Deviation 10.3 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent: Completers End of Part B | 58.1 score on a scale | Standard Deviation 9.4 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived Limitations: Baseline | 53.7 score on a scale | Standard Deviation 12.9 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Baseline | 54.0 score on a scale | Standard Deviation 11.2 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Completers End of Part A | 52.0 score on a scale | Standard Deviation 7.7 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Completers End of Part B | 55.1 score on a scale | Standard Deviation 12.7 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Completers End of Part B | 48.7 score on a scale | Standard Deviation 5.7 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived: Completers End of Part A | 49.5 score on a scale | Standard Deviation 5.8 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived Limitations: Baseline | 49.8 score on a scale | Standard Deviation 6.6 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Perceived: Completers End of Part B | 47.6 score on a scale | Standard Deviation 4.6 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent of Participation: Baseline | 53.1 score on a scale | Standard Deviation 9.1 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Completers End of Part A | 48.3 score on a scale | Standard Deviation 4.7 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent: Completers End of Part A | 52.4 score on a scale | Standard Deviation 8.2 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Satisfaction: Baseline | 48.6 score on a scale | Standard Deviation 6.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | CRIS Extent: Completers End of Part B | 51.3 score on a scale | Standard Deviation 8.6 |
Comparison: Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).p-value: 0.688195% CI: [-1.86, 2.79]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).p-value: 0.736395% CI: [-5.01, 3.67]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).p-value: 0.236195% CI: [-3.99, 1.01]t-test, 2 sided
Comparison: Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.093295% CI: [-15.43, 1.29]Regression, Linear
Comparison: Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.095195% CI: [-22.9, 1.99]Regression, Linear
Comparison: Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.234695% CI: [-13.3, 3.43]Regression, Linear
Secondary
Three Scales of the Veterans Version of the SF-36
Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Baseline participants and completers at End of A and End of B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical: Participants at Baseline | 80.0 score on a scale | Standard Deviation 18.8 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical:Completers at End of Part A | 77.8 score on a scale | Standard Deviation 21.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Completers at End of Part A | 86.4 score on a scale | Standard Deviation 23.3 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Participants at Baseline | 82.6 score on a scale | Standard Deviation 15.8 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Completers at End of Part A | 80.4 score on a scale | Standard Deviation 18.2 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Completers at End of B | 82.6 score on a scale | Standard Deviation 18.4 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical: Completers at End of B | 82.2 score on a scale | Standard Deviation 17.7 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Participants at Baseline | 88.5 score on a scale | Standard Deviation 18 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Completers End of B | 86.8 score on a scale | Standard Deviation 15.9 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical: Completers at End of B | 72.3 score on a scale | Standard Deviation 22.2 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Completers End of B | 80.4 score on a scale | Standard Deviation 18.9 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Completers at End of B | 55.7 score on a scale | Standard Deviation 15.4 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Participants at Baseline | 86.5 score on a scale | Standard Deviation 13.9 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical: Participants at Baseline | 74.5 score on a scale | Standard Deviation 24.3 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Role Physical:Completers at End of Part A | 71.3 score on a scale | Standard Deviation 25.7 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Participants at Baseline | 68.8 score on a scale | Standard Deviation 22.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Social Functioning: Completers at End of Part A | 77.5 score on a scale | Standard Deviation 19.4 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Three Scales of the Veterans Version of the SF-36 | Physical Functioning: Completers at End of Part A | 68.5 score on a scale | Standard Deviation 24.2 |
Comparison: Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).p-value: 0.546595% CI: [-7.53, 4.05]t-test, 2 sided
Comparison: Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).p-value: 0.16195% CI: [-9.12, 1.57]t-test, 2 sided
Comparison: Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).p-value: 0.776595% CI: [-4.9, 3.68]t-test, 2 sided
Comparison: Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.066995% CI: [-27.72, 1.02]Regression, Linear
Comparison: Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.259295% CI: [-23.01, 6.54]Regression, Linear
Comparison: Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: <0.000195% CI: [-43.23, -17.23]Regression, Linear
Secondary
Timed Measure of Activity Performance (T-MAP)
The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Baseline participants and completers at End of A and End of B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Timed Measure of Activity Performance (T-MAP) | Prosthesis users at baseline | 459.8 Seconds | Standard Deviation 223.6 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Timed Measure of Activity Performance (T-MAP) | Completers End of Part A | 748.1 Seconds | Standard Deviation 461.7 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Timed Measure of Activity Performance (T-MAP) | Completers End of Part B | 624.8 Seconds | Standard Deviation 429.1 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Timed Measure of Activity Performance (T-MAP) | Prosthesis users at baseline | 366.5 Seconds | Standard Deviation 108.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Timed Measure of Activity Performance (T-MAP) | Completers End of Part A | 549.0 Seconds | Standard Deviation 257.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Timed Measure of Activity Performance (T-MAP) | Completers End of Part B | 443.3 Seconds | Standard Deviation 154.2 |
Comparison: Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).p-value: <0.000195% CI: [146.7, 360.5]t-test, 2 sided
Comparison: Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.339795% CI: [-574.3, 208.2]Regression, Linear
Secondary
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Prosthesis users only, at baseline, completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Prosthesis users at baseline | 3.6 score on a scale | Standard Deviation 0.7 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Completers End of Part A | 3.5 score on a scale | Standard Deviation 0.7 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Completers End of B | 3.8 score on a scale | Standard Deviation 0.9 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Prosthesis users at baseline | 3.7 score on a scale | Standard Deviation 0.8 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Completers End of Part A | 3.0 score on a scale | Standard Deviation 0.6 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | Completers End of B | 2.7 score on a scale | Standard Deviation 1.1 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).p-value: 0.18695% CI: [-0.55, 0.11]t-test, 2 sided
Comparison: Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.016895% CI: [-2.06, -0.23]Regression, Linear
Secondary
University of New Brunswick Test of Prosthetic Function (UNB)
This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. Each task was rated for both spontaneity and skill. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick & smooth). Summary scores are calculated for each subscale by averaging items and range from 0 to 4 with higher scores reflecting higher spontaneity and skill.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Prosthesis users only, at baseline, completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontanaity: Prosthesis users at baseline | 3.1 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontanaity: Completers End of Part A | 3.0 score on a scale | Standard Deviation 0.4 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontaneity: Completers End of Part B | 3.2 score on a scale | Standard Deviation 0.4 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Prosthesis users at baseline | 3.0 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Completers End of Part A | 2.8 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Completers End of Part B | 3.1 score on a scale | Standard Deviation 0.4 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Completers End of Part A | 2.9 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontanaity: Prosthesis users at baseline | 3.2 score on a scale | Standard Deviation 0.4 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Prosthesis users at baseline | 3.0 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontanaity: Completers End of Part A | 3.1 score on a scale | Standard Deviation 0.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Skill: Completers End of Part B | 3.2 score on a scale | Standard Deviation 0.3 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | University of New Brunswick Test of Prosthetic Function (UNB) | UNB Spontaneity: Completers End of Part B | 3.4 score on a scale | Standard Deviation 0.3 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).p-value: 0.652995% CI: [-0.24, 0.15]t-test, 2 sided
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).p-value: 0.84995% CI: [-0.26, 0.22]t-test, 2 sided
Comparison: Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.458995% CI: [-0.22, 0.48]Regression, Linear
Comparison: Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.71195% CI: [-0.31, 0.44]Regression, Linear
Secondary
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods and ranged from 0 to 100 with lower scores reflecting better function.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Baseline participants and completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Prosthesis users at baseline | 42.4 score on a scale | Standard Deviation 8.1 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Completers End of Part A | 44.3 score on a scale | Standard Deviation 6.3 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Completers End of Part B | 38.0 score on a scale | Standard Deviation 9.5 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Prosthesis users at baseline | 37.6 score on a scale | Standard Deviation 14.9 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Completers End of Part A | 45.8 score on a scale | Standard Deviation 8.2 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | Completers End of Part B | 41.5 score on a scale | Standard Deviation 8.3 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).p-value: 0.046595% CI: [0.07, 8.53]t-test, 2 sided
Comparison: Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: 0.34595% CI: [-7.6, 2.82]Regression, Linear
Secondary
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion of activities performed using a prosthesis.
Time frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Population: Prosthesis users only, at baseline, completers at End of A and End of B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Prosthesis users at baseline | 0.3 proportion of activities performed | Standard Deviation 0.3 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Completers End of Part A | 0.7 proportion of activities performed | Standard Deviation 0.3 |
| Advanced Upper Limb Prosthetic Device IMU Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Completers End of B | 0.6 proportion of activities performed | Standard Deviation 0.2 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Prosthesis users at baseline | 0.4 proportion of activities performed | Standard Deviation 0.3 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Completers End of Part A | 0.6 proportion of activities performed | Standard Deviation 0.3 |
| Advanced Upper Limb Prosthetic EMG-PR Controlled | Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Completers End of B | 0.1 proportion of activities performed | Standard Deviation 0.1 |
Comparison: Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).p-value: <0.000195% CI: [0.17, 0.43]t-test, 2 sided
Comparison: Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.p-value: <0.000195% CI: [-0.73, -0.4]Regression, Linear