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Upper Extremity Orthoses Combined With Occupational Therapy in Subacute Stroke
Sponsor: University of Western Macedonia
Summary
This randomized controlled trial will investigate whether static or dynamic hand orthoses used as adjuncts to occupational therapy improve upper extremity recovery in adults with subacute stroke. Participants will be randomly assigned to one of three parallel groups: conventional occupational therapy alone, occupational therapy combined with a dynamic hand orthosis, or occupational therapy combined with a static hand orthosis. All groups will receive a standardized occupational therapy program for 4 weeks. Participants in the two orthosis groups will additionally use the assigned orthosis for 120 minutes per day, 5 days per week, following the occupational therapy session. Clinical outcomes will be assessed at baseline, at the end of the 4-week intervention, and at 8 weeks from the start of the intervention. The primary outcome will be upper extremity motor function assessed with the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).
Official title: Static and Dynamic Hand Orthoses as Adjuncts to Occupational Therapy for Upper Extremity Recovery After Subacute Stroke: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Standardized Occupational Therapy
A standardized, individualized occupational therapy program focused on upper extremity rehabilitation. Treatment may include mobilization, motor control training, hand function activities, muscle activation and strengthening, task-oriented functional activities, activities of daily living, sensory retraining when clinically indicated, and motor learning strategies. Sessions will last 45 minutes and will be delivered 5 days per week for 4 weeks, for a planned total of 20 sessions.
Dynamic Hand Orthosis
A dynamic hand orthosis used as an adjunct to the standardized occupational therapy program. The orthosis will be worn for 120 minutes per day, 5 days per week for 4 weeks, following completion of the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.
Static Resting Hand Orthosis
A commercially available static resting hand orthosis (VITA Orthopaedics Resting Hand Orthosis 03-2-005) used as an adjunct to the standardized occupational therapy program. The orthosis will be worn for 120 minutes per day, 5 days per week for 4 weeks, following completion of the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.
Locations (1)
ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki
Thermi, Central Macedonia, Greece