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Forearm Rotation Orthosis for Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987414
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: occupational therapy task-oriented approach Device: Forearm rotation orthosis Other: No treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Group A
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
Behavioral: 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.
Other Name: OT task-oriented approach

Device: 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.

Active Comparator: Group B
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
Behavioral: 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.
Other Name: OT task-oriented approach

Other: No treatment
Participants will maintain their daily routines during the no treatment period.
Other Name: control




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987414


Locations
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United States, Minnesota
Children's Rehabilitation Building, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Chih-Huang Yu, MS Rehabilitation Science Program at the University of Minnesota
Study Director: Virgil Mathiowetz, PhD Program in Occupational Therapy, University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Publications:
Gillen G. Upper extremity function and management. In G. Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby, 2011.
Milazzo S, Gillen G. Splinting applications. In G Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby, 2011

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01987414    
Other Study ID Numbers: 1309M42881
First Posted: November 19, 2013    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information gathered from outcome measures will be shared with other researchers at request. Study PI will seek approval from IRB at the University of Minnesota for means of sharing. Researchers will need to contact the study PI to obtain the information.
Keywords provided by University of Minnesota:
Stroke
Cardiovascular Accident
Task-oriented approach
Orthosis
occupational therapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases