Static and Dynamic Hand Orthoses as Adjuncts to Occupational Therapy for Upper Extremity Recovery After Subacute Stroke: A Randomized Controlled Trial
Sponsor study identifier
interventional
102
1 country
1
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2, 2026
Actual (reported)October 7, 2026
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)
Upper extremity motor function will be assessed using the FMA-UE, which evaluates motor impairment and recovery of the affected upper extremity after stroke. The total FMA-UE motor score ranges from 0 to 66, with higher scores indicating better motor function.
Baseline, Week 4, and Week 8
Modified Ashworth Scale (MAS)
Baseline, Week 4, and Week 8
Medical Research Council Scale (MRC) - Finger Flexion
Baseline, Week 4, and Week 8
Medical Research Council Scale (MRC) - Finger Extension
Baseline, Week 4, and Week 8
Hand Dynamometer (JAMAR)
Baseline, Week 4, and Week 8
Box and Block Test (BBT)
Baseline, Week 4, and Week 8
Participants will receive a standardized occupational therapy program consisting of 45-minute sessions, 5 days per week for 4 weeks, for a planned total of 20 sessions. No upper extremity orthosis will be used as part of the study intervention.
Participants will receive the same standardized occupational therapy program as the control group and will additionally use a dynamic hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session.
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.
ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki
Thermi, Central Macedonia, 57001, Greece
Georgios Kalogirou, MSc
University of Western Macedonia
Ioannis Ventoulis, PhD
University of Western Macedonia
First Submitted
October 2, 2026
First Posted
October 7, 2026
Study Start
October 2026
Effect of DFM on Quadriceps Spasticity in Stroke Patients
Participants will receive the same standardized occupational therapy program as the control group and will additionally use a static hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session.
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.
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-10
Individual participant data (IPD) will not be shared with other researchers because the study protocol does not include a predefined data-sharing plan. Participant data will be pseudonymized and used exclusively for the purposes of this doctoral research, in accordance with the approved protocol, institutional requirements, and applicable data protection regulations.
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Source: ClinicalTrials.gov.
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