Forearm Rotation Orthosis for Stroke

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01987414
First received: October 29, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Stroke
Behavioral: occupational therapy task-oriented approach
Device: Forearm rotation orthosis
Other: No treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Canadian Occupational Performance Measure [ Time Frame: Week 1, 8, and 15 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Goniometric measurements [ Time Frame: Week 1, 8, and 15 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Orthosis wearing diary [ Time Frame: Week 1 through 15 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987414

Contacts
Contact: Chih-Huang Yu, MS 4259855517 yuxxx648@umn.edu
Contact: Virgil Mathiowetz, PhD 6126263759 mathi003@umn.edu

Locations
United States, Minnesota
Sister Kenny Rehabilitation Institute: Research Center Not yet recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Matthew White, BS    612-863-7642    matthew.white@allina.com   
Sub-Investigator: Matthew White, BS         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
  More Information

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01987414     History of Changes
Other Study ID Numbers: 1309M42881
Study First Received: October 29, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Stroke
Cardiovascular Accident
Task-oriented approach
Orthosis
occupational therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 27, 2014