Stroke
Conditions
Keywords
Stroke, Cardiovascular Accident, Task-oriented approach, Orthosis, occupational therapy
Brief summary
The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm. Hypotheses of this study are: 1. participants who wear the forearm rotation orthosis will demonstrate significantly greater improvement in functional performance and active range of motion of forearm rotators compared to those who do not; 2. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and 3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.
Detailed description
Persons with central nervous system (CNS) dysfunction often have difficulty incorporating their affected limb effectively and efficiently into functional tasks due to muscle weakness and/or spasticity. This may further interfere with their performance of everyday activities and restrict life roles. Traditional rehabilitation interventions emphasize spasticity reduction. However, active movement and muscle strength of forearm supination are found strongly related to motor function, rather than spasticity. In contrast, task-oriented movement training trials have demonstrated promising evidence that persons with CNS dysfunction benefit from the training in improvement of motor function and increase functional use of the affected limb. Orthotic intervention is one therapeutic option for this population. Most orthotic designs for this population are static, developed for sympton reduction or deformity prevention, and aimed at the wrist and hand. However, its effects on spasticity reduction remain controversial. Given that static orthotics may interfere with functional performance and further develop the learned nonuse of the affected limb, a dynamic or mobilization orthosis would be appropriate for enhancing functional performance. Moreover, an orthosis that assists forearm rotation is speculated to enhance functional performance. This study will examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm.
Interventions
BEHAVIORALoccupational therapy task-oriented approach
It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
DEVICEForearm rotation orthosis
The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.
OTHERNo treatment
Participants will maintain their daily routines during the no treatment period.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of stroke for at least three months * Be 18 years of age or older * Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent * Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity * Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension) * Not receive any rehabilitative interventions concurrent with the study
Exclusion criteria
* Severe joint deformities or contractures of the affected upper extremity that limit range of motion required for functional tasks * Capability of voluntarily extending the wrist and fingers through the full range * Other rehabilitation interventions concurrent with the study * Have serious uncontrolled medical problems, such as seizures and visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) - Performance | Week 1, 8, and 15 | Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 1, 8, and 15 | Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Wolf Motor Function Test (WMFT) - Time | Week 1, 8, and 15 | This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Wolf Motor Function Test (WMFT) - Function | Week 1, 8, and 15 | This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Motor Activity Log (MAL) - Amount of Use | Week 1, 8, and 15 | This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Motor Activity Log (MAL) - How Well | Week 1, 8, and 15 | This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Strength - Shoulder Flexion | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Shoulder Abduction | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Elbow Extension | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Forearm Pronation | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Shoulder Flexion | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Wrist Extension | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Grip | Week 1, 8, and 15 | A Jamar Dynamometer will be used to measure grip strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Palmar Pinch | Week 1, 8, and 15 | A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Lateral Pinch | Week 1, 8, and 15 | A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Upper Extremity Strength - Forearm Supination | Week 1, 8, and 15 | A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Shoulder Abduction | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Elbow Extension | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Forearm Pronation | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Forearm Supination | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
| Goniometric Measurements - Wrist Extension | Week 1, 8, and 15 | A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
Forearm rotation orthosis: The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension. | 8 |
| Group B no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
No treatment: Participants will maintain their daily routines during the no treatment period. | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Group B | Total | Group A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 13 Participants | 8 Participants |
| Age, Continuous | 58.5 year STANDARD_DEVIATION 10.17 | 55.86 year STANDARD_DEVIATION 11.09 | 53.88 year STANDARD_DEVIATION 11.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 14 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
Primary
Canadian Occupational Performance Measure (COPM) - Performance
Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Canadian Occupational Performance Measure (COPM) - Performance | Week 1 (Pre-test) | 2.95 score on a scale | Standard Deviation 0.77 |
| Group A | Canadian Occupational Performance Measure (COPM) - Performance | Week 8 (Post-test 1) | 3.3 score on a scale | Standard Deviation 1.21 |
| Group A | Canadian Occupational Performance Measure (COPM) - Performance | Week 15 (Post-test 2) | 5.8 score on a scale | Standard Deviation 1.34 |
| Group B | Canadian Occupational Performance Measure (COPM) - Performance | Week 1 (Pre-test) | 3.77 score on a scale | Standard Deviation 1.33 |
| Group B | Canadian Occupational Performance Measure (COPM) - Performance | Week 8 (Post-test 1) | 3.43 score on a scale | Standard Deviation 1.05 |
| Group B | Canadian Occupational Performance Measure (COPM) - Performance | Week 15 (Post-test 2) | 5.98 score on a scale | Standard Deviation 1.53 |
Primary
Canadian Occupational Performance Measure (COPM) - Satisfaction
Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 1 (Pre-test) | 2.73 score on a scale | Standard Deviation 1.11 |
| Group A | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 8 (Post-test 1) | 3.18 score on a scale | Standard Deviation 1.54 |
| Group A | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 15 (Post-test 2) | 5.93 score on a scale | Standard Deviation 1.19 |
| Group B | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 1 (Pre-test) | 3.17 score on a scale | Standard Deviation 1.48 |
| Group B | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 8 (Post-test 1) | 3.1 score on a scale | Standard Deviation 1.18 |
| Group B | Canadian Occupational Performance Measure (COPM) - Satisfaction | Week 15 (Post-test 2) | 5.65 score on a scale | Standard Deviation 1.29 |
Primary
Motor Activity Log (MAL) - Amount of Use
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Motor Activity Log (MAL) - Amount of Use | Week 1 (Pre-test) | .46 score on a scale | Standard Deviation 0.42 |
| Group A | Motor Activity Log (MAL) - Amount of Use | Week 8 (Post-test 1) | .56 score on a scale | Standard Deviation 0.57 |
| Group A | Motor Activity Log (MAL) - Amount of Use | Week 15 (Post-test 2) | .81 score on a scale | Standard Deviation 0.64 |
| Group B | Motor Activity Log (MAL) - Amount of Use | Week 1 (Pre-test) | 1.06 score on a scale | Standard Deviation 0.85 |
| Group B | Motor Activity Log (MAL) - Amount of Use | Week 15 (Post-test 2) | 1.61 score on a scale | Standard Deviation 1.22 |
| Group B | Motor Activity Log (MAL) - Amount of Use | Week 8 (Post-test 1) | 1.01 score on a scale | Standard Deviation 0.96 |
Primary
Motor Activity Log (MAL) - How Well
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Motor Activity Log (MAL) - How Well | Week 1 (Pre-test) | .52 units on a scale | Standard Deviation 0.47 |
| Group A | Motor Activity Log (MAL) - How Well | Week 8 (Post-test 1) | .56 units on a scale | Standard Deviation 0.54 |
| Group A | Motor Activity Log (MAL) - How Well | Week 15 (Post-test 2) | .86 units on a scale | Standard Deviation 0.66 |
| Group B | Motor Activity Log (MAL) - How Well | Week 1 (Pre-test) | 1.15 units on a scale | Standard Deviation 0.75 |
| Group B | Motor Activity Log (MAL) - How Well | Week 8 (Post-test 1) | 1.18 units on a scale | Standard Deviation 1.19 |
| Group B | Motor Activity Log (MAL) - How Well | Week 15 (Post-test 2) | 1.63 units on a scale | Standard Deviation 1.2 |
Primary
Wolf Motor Function Test (WMFT) - Function
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Wolf Motor Function Test (WMFT) - Function | Week 1 (Pre-test) | 2.07 score on a scale | Standard Deviation 0.35 |
| Group A | Wolf Motor Function Test (WMFT) - Function | Week 8 (Post-test 1) | 2.16 score on a scale | Standard Deviation 0.41 |
| Group A | Wolf Motor Function Test (WMFT) - Function | Week 15 (Post-test 2) | 2.16 score on a scale | Standard Deviation 0.36 |
| Group B | Wolf Motor Function Test (WMFT) - Function | Week 1 (Pre-test) | 2.8 score on a scale | Standard Deviation 0.94 |
| Group B | Wolf Motor Function Test (WMFT) - Function | Week 8 (Post-test 1) | 2.77 score on a scale | Standard Deviation 1.33 |
| Group B | Wolf Motor Function Test (WMFT) - Function | Week 15 (Post-test 2) | 2.9 score on a scale | Standard Deviation 1.33 |
Primary
Wolf Motor Function Test (WMFT) - Time
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Wolf Motor Function Test (WMFT) - Time | Week 1 (Pre-test) | 66.25 seconds | Standard Deviation 17.99 |
| Group A | Wolf Motor Function Test (WMFT) - Time | Week 8 (Post-test 1) | 63.25 seconds | Standard Deviation 14.88 |
| Group A | Wolf Motor Function Test (WMFT) - Time | Week 15 (Post-test 2) | 61.41 seconds | Standard Deviation 15.57 |
| Group B | Wolf Motor Function Test (WMFT) - Time | Week 1 (Pre-test) | 40.38 seconds | Standard Deviation 40.45 |
| Group B | Wolf Motor Function Test (WMFT) - Time | Week 8 (Post-test 1) | 39.15 seconds | Standard Deviation 39.49 |
| Group B | Wolf Motor Function Test (WMFT) - Time | Week 15 (Post-test 2) | 44.65 seconds | Standard Deviation 39.36 |
Secondary
Goniometric Measurements - Elbow Extension
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Elbow Extension | Week 1 (Pre-test) | 117.25 degrees | Standard Deviation 17.52 |
| Group A | Goniometric Measurements - Elbow Extension | Week 8 (Post-test 1) | 113.13 degrees | Standard Deviation 21.01 |
| Group A | Goniometric Measurements - Elbow Extension | Week 15 (Post-test 2) | 125.25 degrees | Standard Deviation 10.31 |
| Group B | Goniometric Measurements - Elbow Extension | Week 1 (Pre-test) | 103.67 degrees | Standard Deviation 33.21 |
| Group B | Goniometric Measurements - Elbow Extension | Week 8 (Post-test 1) | 97.5 degrees | Standard Deviation 21.36 |
| Group B | Goniometric Measurements - Elbow Extension | Week 15 (Post-test 2) | 119.83 degrees | Standard Deviation 30.22 |
Secondary
Goniometric Measurements - Forearm Pronation
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Forearm Pronation | Week 1 (Pre-test) | 63.13 degrees | Standard Deviation 19.14 |
| Group A | Goniometric Measurements - Forearm Pronation | Week 8 (Post-test 1) | 61.63 degrees | Standard Deviation 30.42 |
| Group A | Goniometric Measurements - Forearm Pronation | Week 15 (Post-test 2) | 65.63 degrees | Standard Deviation 23.37 |
| Group B | Goniometric Measurements - Forearm Pronation | Week 1 (Pre-test) | 67.67 degrees | Standard Deviation 16.81 |
| Group B | Goniometric Measurements - Forearm Pronation | Week 8 (Post-test 1) | 64 degrees | Standard Deviation 27.94 |
| Group B | Goniometric Measurements - Forearm Pronation | Week 15 (Post-test 2) | 59.17 degrees | Standard Deviation 18.28 |
Secondary
Goniometric Measurements - Forearm Supination
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Forearm Supination | Week 1 (Pre-test) | 38 degrees | Standard Deviation 29.89 |
| Group A | Goniometric Measurements - Forearm Supination | Week 8 (Post-test 1) | 38.13 degrees | Standard Deviation 29.92 |
| Group A | Goniometric Measurements - Forearm Supination | Week 15 (Post-test 2) | 55.13 degrees | Standard Deviation 27.48 |
| Group B | Goniometric Measurements - Forearm Supination | Week 1 (Pre-test) | 51.33 degrees | Standard Deviation 24.87 |
| Group B | Goniometric Measurements - Forearm Supination | Week 8 (Post-test 1) | 47.5 degrees | Standard Deviation 33.58 |
| Group B | Goniometric Measurements - Forearm Supination | Week 15 (Post-test 2) | 53.33 degrees | Standard Deviation 27.14 |
Secondary
Goniometric Measurements - Shoulder Abduction
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Shoulder Abduction | Week 1 (Pre-test) | 96 degrees | Standard Deviation 33.56 |
| Group A | Goniometric Measurements - Shoulder Abduction | Week 8 (Post-test 1) | 85.75 degrees | Standard Deviation 25.27 |
| Group A | Goniometric Measurements - Shoulder Abduction | Week 15 (Post-test 2) | 87.75 degrees | Standard Deviation 31.35 |
| Group B | Goniometric Measurements - Shoulder Abduction | Week 1 (Pre-test) | 95.17 degrees | Standard Deviation 32.33 |
| Group B | Goniometric Measurements - Shoulder Abduction | Week 8 (Post-test 1) | 87.83 degrees | Standard Deviation 26.28 |
| Group B | Goniometric Measurements - Shoulder Abduction | Week 15 (Post-test 2) | 90.33 degrees | Standard Deviation 27.34 |
Secondary
Goniometric Measurements - Shoulder Flexion
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Shoulder Flexion | Week 1 (Pre-test) | 103.5 degrees | Standard Deviation 30.56 |
| Group A | Goniometric Measurements - Shoulder Flexion | Week 8 (Post-test 1) | 92.75 degrees | Standard Deviation 33.52 |
| Group A | Goniometric Measurements - Shoulder Flexion | Week 15 (Post-test 2) | 100.38 degrees | Standard Deviation 38.06 |
| Group B | Goniometric Measurements - Shoulder Flexion | Week 1 (Pre-test) | 99 degrees | Standard Deviation 41.91 |
| Group B | Goniometric Measurements - Shoulder Flexion | Week 8 (Post-test 1) | 93 degrees | Standard Deviation 29.15 |
| Group B | Goniometric Measurements - Shoulder Flexion | Week 15 (Post-test 2) | 96 degrees | Standard Deviation 29.5 |
Secondary
Goniometric Measurements - Wrist Extension
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Goniometric Measurements - Wrist Extension | Week 1 (Pre-test) | 20.25 degrees | Standard Deviation 17.5 |
| Group A | Goniometric Measurements - Wrist Extension | Week 8 (Post-test 1) | 23.13 degrees | Standard Deviation 19.81 |
| Group A | Goniometric Measurements - Wrist Extension | Week 15 (Post-test 2) | 26.25 degrees | Standard Deviation 21.67 |
| Group B | Goniometric Measurements - Wrist Extension | Week 8 (Post-test 1) | 40.38 degrees | Standard Deviation 22.71 |
| Group B | Goniometric Measurements - Wrist Extension | Week 15 (Post-test 2) | 39.17 degrees | Standard Deviation 22.23 |
| Group B | Goniometric Measurements - Wrist Extension | Week 1 (Pre-test) | 36.67 degrees | Standard Deviation 19.4 |
Secondary
Upper Extremity Strength - Elbow Extension
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Elbow Extension | Week 1 (Pre-test) | 12.9 lbs | Standard Deviation 5.27 |
| Group A | Upper Extremity Strength - Elbow Extension | Week 8 (Post-test 1) | 11.98 lbs | Standard Deviation 3.13 |
| Group A | Upper Extremity Strength - Elbow Extension | Week 15 (Post-test 2) | 12.81 lbs | Standard Deviation 6.62 |
| Group B | Upper Extremity Strength - Elbow Extension | Week 1 (Pre-test) | 13.97 lbs | Standard Deviation 7.77 |
| Group B | Upper Extremity Strength - Elbow Extension | Week 8 (Post-test 1) | 16.43 lbs | Standard Deviation 7.81 |
| Group B | Upper Extremity Strength - Elbow Extension | Week 15 (Post-test 2) | 17.56 lbs | Standard Deviation 10.46 |
Secondary
Upper Extremity Strength - Forearm Pronation
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Forearm Pronation | Week 1 (Pre-test) | 10.83 lbs | Standard Deviation 4.99 |
| Group A | Upper Extremity Strength - Forearm Pronation | Week 8 (Post-test 1) | 10.97 lbs | Standard Deviation 3.6 |
| Group A | Upper Extremity Strength - Forearm Pronation | Week 15 (Post-test 2) | 11.74 lbs | Standard Deviation 6.29 |
| Group B | Upper Extremity Strength - Forearm Pronation | Week 1 (Pre-test) | 11.87 lbs | Standard Deviation 5.49 |
| Group B | Upper Extremity Strength - Forearm Pronation | Week 8 (Post-test 1) | 11.51 lbs | Standard Deviation 6.3 |
| Group B | Upper Extremity Strength - Forearm Pronation | Week 15 (Post-test 2) | 11.98 lbs | Standard Deviation 9.96 |
Secondary
Upper Extremity Strength - Forearm Supination
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Forearm Supination | Week 1 (Pre-test) | 6.06 lbs | Standard Deviation 4.86 |
| Group A | Upper Extremity Strength - Forearm Supination | Week 15 (Post-test 2) | 6.3 lbs | Standard Deviation 3.36 |
| Group A | Upper Extremity Strength - Forearm Supination | Week 8 (Post-test 1) | 5.76 lbs | Standard Deviation 3.56 |
| Group B | Upper Extremity Strength - Forearm Supination | Week 1 (Pre-test) | 7.74 lbs | Standard Deviation 3.74 |
| Group B | Upper Extremity Strength - Forearm Supination | Week 8 (Post-test 1) | 6.58 lbs | Standard Deviation 3.12 |
| Group B | Upper Extremity Strength - Forearm Supination | Week 15 (Post-test 2) | 8.15 lbs | Standard Deviation 3.74 |
Secondary
Upper Extremity Strength - Grip
A Jamar Dynamometer will be used to measure grip strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Grip | Week 1 (Pre-test) | 13.21 lbs | Standard Deviation 7.06 |
| Group A | Upper Extremity Strength - Grip | Week 15 (Post-test 2) | 17.38 lbs | Standard Deviation 6.79 |
| Group A | Upper Extremity Strength - Grip | Week 8 (Post-test 1) | 13.77 lbs | Standard Deviation 9.62 |
| Group B | Upper Extremity Strength - Grip | Week 8 (Post-test 1) | 28.5 lbs | Standard Deviation 22.33 |
| Group B | Upper Extremity Strength - Grip | Week 15 (Post-test 2) | 28.55 lbs | Standard Deviation 17.76 |
| Group B | Upper Extremity Strength - Grip | Week 1 (Pre-test) | 29.39 lbs | Standard Deviation 18.83 |
Secondary
Upper Extremity Strength - Lateral Pinch
A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Lateral Pinch | Week 1 (Pre-test) | 6.94 lbs | Standard Deviation 3.71 |
| Group A | Upper Extremity Strength - Lateral Pinch | Week 8 (Post-test 1) | 7.32 lbs | Standard Deviation 4.82 |
| Group A | Upper Extremity Strength - Lateral Pinch | Week 15 (Post-test 2) | 9.27 lbs | Standard Deviation 3.53 |
| Group B | Upper Extremity Strength - Lateral Pinch | Week 1 (Pre-test) | 17.72 lbs | Standard Deviation 12.61 |
| Group B | Upper Extremity Strength - Lateral Pinch | Week 8 (Post-test 1) | 16.72 lbs | Standard Deviation 14.28 |
| Group B | Upper Extremity Strength - Lateral Pinch | Week 15 (Post-test 2) | 16.84 lbs | Standard Deviation 11.13 |
Secondary
Upper Extremity Strength - Palmar Pinch
A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Palmar Pinch | Week 1 (Pre-test) | .67 lbs | Standard Deviation 1.28 |
| Group A | Upper Extremity Strength - Palmar Pinch | Week 8 (Post-test 1) | .88 lbs | Standard Deviation 1.1 |
| Group A | Upper Extremity Strength - Palmar Pinch | Week 15 (Post-test 2) | 1.17 lbs | Standard Deviation 1.73 |
| Group B | Upper Extremity Strength - Palmar Pinch | Week 1 (Pre-test) | 6.06 lbs | Standard Deviation 6.5 |
| Group B | Upper Extremity Strength - Palmar Pinch | Week 8 (Post-test 1) | 4.95 lbs | Standard Deviation 6.71 |
| Group B | Upper Extremity Strength - Palmar Pinch | Week 15 (Post-test 2) | 5.11 lbs | Standard Deviation 5.78 |
Secondary
Upper Extremity Strength - Shoulder Abduction
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Shoulder Abduction | Week 1 (Pre-test) | 15.1 lbs | Standard Deviation 6.24 |
| Group A | Upper Extremity Strength - Shoulder Abduction | Week 8 (Post-test 1) | 15.32 lbs | Standard Deviation 6.57 |
| Group A | Upper Extremity Strength - Shoulder Abduction | Week 15 (Post-test 2) | 17.65 lbs | Standard Deviation 9.7 |
| Group B | Upper Extremity Strength - Shoulder Abduction | Week 1 (Pre-test) | 17.82 lbs | Standard Deviation 10.69 |
| Group B | Upper Extremity Strength - Shoulder Abduction | Week 8 (Post-test 1) | 16.99 lbs | Standard Deviation 11.73 |
| Group B | Upper Extremity Strength - Shoulder Abduction | Week 15 (Post-test 2) | 18.68 lbs | Standard Deviation 13.61 |
Secondary
Upper Extremity Strength - Shoulder Flexion
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Shoulder Flexion | Week 1 (Pre-test) | 14.91 lbs | Standard Deviation 7.01 |
| Group A | Upper Extremity Strength - Shoulder Flexion | Week 8 (Post-test 1) | 15.13 lbs | Standard Deviation 5.3 |
| Group A | Upper Extremity Strength - Shoulder Flexion | Week 15 (Post-test 2) | 17.36 lbs | Standard Deviation 10.08 |
| Group B | Upper Extremity Strength - Shoulder Flexion | Week 1 (Pre-test) | 14.48 lbs | Standard Deviation 6.99 |
| Group B | Upper Extremity Strength - Shoulder Flexion | Week 8 (Post-test 1) | 18.06 lbs | Standard Deviation 11.53 |
| Group B | Upper Extremity Strength - Shoulder Flexion | Week 15 (Post-test 2) | 21.13 lbs | Standard Deviation 15.22 |
Secondary
Upper Extremity Strength - Wrist Extension
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Time frame: Week 1, 8, and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Upper Extremity Strength - Wrist Extension | Week 1 (Pre-test) | 8.72 lbs | Standard Deviation 6.13 |
| Group A | Upper Extremity Strength - Wrist Extension | Week 8 (Post-test 1) | 8.38 lbs | Standard Deviation 5.76 |
| Group A | Upper Extremity Strength - Wrist Extension | Week 15 (Post-test 2) | 9.74 lbs | Standard Deviation 6.17 |
| Group B | Upper Extremity Strength - Wrist Extension | Week 1 (Pre-test) | 11.98 lbs | Standard Deviation 7.2 |
| Group B | Upper Extremity Strength - Wrist Extension | Week 8 (Post-test 1) | 15.2 lbs | Standard Deviation 11.59 |
| Group B | Upper Extremity Strength - Wrist Extension | Week 15 (Post-test 2) | 14.79 lbs | Standard Deviation 11.31 |