Clinical trial NCT01987414: Forearm Rotation Orthosis for Stroke
Official title: Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Cardiovascular Accident
Task-oriented approach
Orthosis
occupational therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM) - Performance
timeFrame: Week 1, 8, and 15
measure: Canadian Occupational Performance Measure (COPM) - Satisfaction
timeFrame: Week 1, 8, and 15
measure: Wolf Motor Function Test (WMFT) - Time
timeFrame: Week 1, 8, and 15
measure: Wolf Motor Function Test (WMFT) - Function
timeFrame: Week 1, 8, and 15
measure: Motor Activity Log (MAL) - Amount of Use
timeFrame: Week 1, 8, and 15
measure: Motor Activity Log (MAL) - How Well
timeFrame: Week 1, 8, and 15
Secondary outcomes:
measure: Goniometric Measurements - Shoulder Flexion
timeFrame: Week 1, 8, and 15
measure: Goniometric Measurements - Shoulder Abduction
timeFrame: Week 1, 8, and 15
measure: Goniometric Measurements - Elbow Extension
timeFrame: Week 1, 8, and 15
measure: Goniometric Measurements - Forearm Pronation
timeFrame: Week 1, 8, and 15
measure: Goniometric Measurements - Forearm Supination
timeFrame: Week 1, 8, and 15
measure: Goniometric Measurements - Wrist Extension
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Shoulder Flexion
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Shoulder Abduction
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Elbow Extension
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Forearm Pronation
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Forearm Supination
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Wrist Extension
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Grip
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Palmar Pinch
timeFrame: Week 1, 8, and 15
measure: Upper Extremity Strength - Lateral Pinch
timeFrame: Week 1, 8, and 15
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Rehabilitation Building, University of Minnesota
state: Minnesota
Study officials:
affiliation: Rehabilitation Science Program at the University of Minnesota
name: Chih-Huang Yu, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Program in Occupational Therapy, University of Minnesota
name: Virgil Mathiowetz, PhD
role: STUDY_DIRECTOR
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