Forearm Rotation Orthosis for Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • No treatment Behavioral
    Intervention Desc: Participants will maintain their daily routines during the no treatment period.
    ARM 1: Kind: Experimental
    Label: Group B
    Description: no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
  • Occupational therapy task-oriented approach Behavioral
    Other Names: OT task-oriented approach
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Group A
    Description: Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
    ARM 2: Kind: Experimental
    Label: Group B
    Description: no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
  • Forearm rotation orthosis Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Group A
    Description: Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Canadian Occupational Performance Measure Week 1, 8, and 15 No
Secondary Goniometric measurements Week 1, 8, and 15 No
Secondary Hand-held dynamometry Week 1, 8, and 15 No
Secondary Manual Muscle Testing Week 1, 8, and 15 No
Secondary Jamar Dynamometer Week 1, 8, and 15 No
Secondary Pinch gauge Week 1, 8, and 15 No
Secondary Wolf Motor Functional Test Week 1, 8, and 15 No
Secondary Motor Activity Log Week 1, 8, and 15 No

Sponsors