Upper Limb Amputation
Conditions
Keywords
amputation, transradial, prosthesis, terminal device
Brief summary
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to: 1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity. 2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.
Detailed description
To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.
Interventions
DEVICEHosmer 5XA voluntary opening hook
Voluntary opening prosthetic terminal device (hand)
DEVICETRS Grip 3 voluntary closing hook
Voluntary closing prosthetic terminal device (hand)
Sponsors
Florida High Tech Corridor Council
TRS, Inc.
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Unilateral transradial or wrist-disarticulation amputee * 18 to 85 years of age * At least 1 year from date of amputation * Be able to independently provide informed consent * Be willing to comply with study procedures
Exclusion criteria
* History of acute or chronic skin breakdown on the residual limb * Prosthetic socket adjustment within 90 days * Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers) * Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures). * Unwillingness/inability to follow instructions Inclusion criteria for able-bodied subjects * 18 to 85 years of age * Able to provide independent, informed consent * Independent function by self-report * Free of any health ailment that would impair physical function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Displacement During Towel Folding Task | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. | Distance sternum is displaced while folding a towel was measured in meters. |
| Physical Function Performance 10 Test Score | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-amputee Control Group non-amputee healthy controls | 10 |
| Experimental Group: Unilateral TR or Wrist-disartic Amputees Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Non-amputee Control Group | Experimental Group: Unilateral TR or Wrist-disartic Amputees | Total |
|---|---|---|---|
| Age, Continuous | 23.6 years STANDARD_DEVIATION 6 | 56.1 years STANDARD_DEVIATION 10.4 | 39.9 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 10 participants | 8 participants | 18 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 10 |
Outcome results
Primary
Physical Function Performance 10 Test Score
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
Time frame: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Hand 1 (Hosmer 5XA) | Physical Function Performance 10 Test Score | 39.1 units on a scale | Standard Deviation 13.5 |
| Prosthetic Hand 2 (TRS Grip 3) | Physical Function Performance 10 Test Score | 37.0 units on a scale | Standard Deviation 18.3 |
| Non-amputee Controls | Physical Function Performance 10 Test Score | 68.1 units on a scale | Standard Deviation 14.2 |
Primary
Sternal Displacement During Towel Folding Task
Distance sternum is displaced while folding a towel was measured in meters.
Time frame: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Hand 1 (Hosmer 5XA) | Sternal Displacement During Towel Folding Task | 1.0 meters | Standard Deviation 0.13 |
| Prosthetic Hand 2 (TRS Grip 3) | Sternal Displacement During Towel Folding Task | 1.06 meters | Standard Deviation 0.12 |
| Non-amputee Controls | Sternal Displacement During Towel Folding Task | 0.88 meters | Standard Deviation 0.18 |