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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

Tracking Information
First Submitted Date  ICMJE October 29, 2013
First Posted Date  ICMJE November 19, 2013
Results First Submitted Date  ICMJE August 6, 2019
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Canadian Occupational Performance Measure [ Time Frame: Week 1, 8, and 15 ]
We use it to evaluate participants' self-perceived functional performance and satisfaction with performance. Collected data will be used to measure changes within and between groups on self-perceived performance and satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Goniometric measurements [ Time Frame: Week 1, 8, and 15 ]
    We will use goniometric measurements to assess active and passive range of motion of the upper extremity. We will measure changes within and between groups in range of motion of the upper extremity between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Hand-held dynamometry [ Time Frame: Week 1, 8, and 15 ]
    It will be used for measuring muscle strength of the upper extremity. We will measure changes within and between groups on muscle strength between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Manual Muscle Testing [ Time Frame: Week 1, 8, and 15 ]
    This test will be used to evaluate muscle strength of the upper extremity. We will measure changes within and between groups on muscle strength between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Jamar Dynamometer [ Time Frame: Week 1, 8, and 15 ]
    We will use this to evaluate participants' grip strength. We will measure changes within and between groups on grip strength between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Pinch gauge [ Time Frame: Week 1, 8, and 15 ]
    This will be used to assess participants' pinch strength. We will measure changes within and between groups on pinch strength between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Wolf Motor Functional Test [ Time Frame: Week 1, 8, and 15 ]
    We use this to quantitatively assess participants' motor function of the upper extremity. We will measure changes within and between groups in motor function between week 1 and 8, week 1 and 15, as well as week 8 and 15.
  • Motor Activity Log [ Time Frame: Week 1, 8, and 15 ]
    This test is used to measuring participants' actual use of the involved arm in the real world. We will measure changes within and between groups in actual use of the arm between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 12, 2013)
Orthosis wearing diary [ Time Frame: Week 1 through 15 ]
Participants in the orthotic wearing condition will need to complete a dairy of orthosis wearing for measuring adherence with the orthosis throughout the study period. Collected data will be used to compare changes within the groups on adherence with the orthosis between week 1 and 8, week 1 and 15, as well as week 8 and 15.
 
Descriptive Information
Brief Title  ICMJE Forearm Rotation Orthosis for Stroke
Official Title  ICMJE Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
  • Other: No treatment
    Participants will maintain their daily routines during the no treatment period.
    Other Name: control
Study Arms  ICMJE
  • Experimental: Group A
    Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
    Interventions:
    • Behavioral: occupational therapy task-oriented approach
    • Device: Forearm rotation orthosis
  • Active Comparator: Group B
    no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
    Interventions:
    • Behavioral: occupational therapy task-oriented approach
    • Other: No treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
40
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987414
Other Study ID Numbers  ICMJE 1309M42881
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Minnesota
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP