Forearm Rotation Orthosis for Stroke

University of Minnesota (UMN)

Status

Completed

Conditions

Stroke

Treatments

Other: No treatment

Device: Forearm rotation orthosis

Behavioral: occupational therapy task-oriented approach

Study type

Interventional

Funder types

Other

Identifiers

NCT01987414

1309M42881

Details and patient eligibility

About

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:

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;
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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