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Completed

NCT Number: NCT01987414

Forearm Rotation Orthosis for Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Rehabilitation Building, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

occupational therapy task-oriented approach

Behavioral

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.

Other names: OT task-oriented approach

Forearm rotation orthosis

Device

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.

No treatment

Other

Participants will maintain their daily routines during the no treatment period.

Other names: control

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM) - Performance

    Time frame: 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.

  2. Canadian Occupational Performance Measure (COPM) - Satisfaction

    Time frame: 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.

  3. Wolf Motor Function Test (WMFT) - Time

    Time frame: 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.

  4. Wolf Motor Function Test (WMFT) - Function

    Time frame: 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.

  5. Motor Activity Log (MAL) - Amount of Use

    Time frame: 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.

  6. Motor Activity Log (MAL) - How Well

    Time frame: 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 outcomes

  1. Goniometric Measurements - Shoulder Flexion

    Time frame: 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.

  2. Goniometric Measurements - Shoulder Abduction

    Time frame: 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.

  3. Goniometric Measurements - Elbow Extension

    Time frame: 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.

  4. Goniometric Measurements - Forearm Pronation

    Time frame: 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.

  5. Goniometric Measurements - Forearm Supination

    Time frame: 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.

  6. Goniometric Measurements - Wrist Extension

    Time frame: 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.

  7. Upper Extremity Strength - Shoulder Flexion

    Time frame: 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.

  8. Upper Extremity Strength - Shoulder Abduction

    Time frame: 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.

  9. Upper Extremity Strength - Elbow Extension

    Time frame: 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.

  10. Upper Extremity Strength - Forearm Pronation

    Time frame: 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.

  11. Upper Extremity Strength - Forearm Supination

    Time frame: 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.

  12. Upper Extremity Strength - Wrist Extension

    Time frame: 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.

  13. Upper Extremity Strength - Grip

    Time frame: 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.

  14. Upper Extremity Strength - Palmar Pinch

    Time frame: 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.

  15. Upper Extremity Strength - Lateral Pinch

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2013
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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