An interventional study of Standardized Occupational Therapy and Dynamic Hand Orthosis in Stroke (Subacute), sponsored by University of Western Macedonia. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Western Macedonia · Not applicable, Interventional, and Treatment
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).
The study is a prospective, randomized, controlled, assessor-blinded, three-arm parallel-group clinical trial involving adults with subacute stroke undergoing inpatient rehabilitation. Its objective is to evaluate the effects of static and dynamic hand orthoses used as adjuncts to a standardized occupational therapy program for upper extremity rehabilitation.
Following baseline assessment, eligible participants will be randomly allocated to one of three groups: occupational therapy alone, occupational therapy combined with a dynamic hand orthosis, or occupational therapy combined with a static hand orthosis. All 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.
The occupational therapy program will follow a common therapeutic framework across all groups and will be individualized according to each participant's motor and functional status. Treatment may include upper extremity 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.
Participants allocated to either orthosis group will additionally use the assigned hand orthosis for 120 minutes per day, 5 days per week for 4 weeks, following the occupational therapy session. Adherence, tolerance, and safety related to orthosis use will be monitored throughout the intervention period.
Outcome assessments will be conducted by independent assessors blinded to group allocation at baseline, at Week 4, immediately following completion of the intervention, and at Week 8 from the start of the intervention. The primary outcome will be upper extremity motor function assessed using the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE). Secondary outcomes will include muscle tone, muscle strength, grip strength, gross manual dexterity, functional independence in activities of daily living, and pain.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 102 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Western Macedonia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Behavioral: Standardized Occupational Therapy
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.
Behavioral: Standardized Occupational Therapy · Device: Dynamic Hand Orthosis
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.
Behavioral: Standardized Occupational Therapy · Device: Static Resting Hand Orthosis
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.
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.
Also known as: Aurafix ORT-07A Thermoplastic Dynamic Splint
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.
Also known as: VITA Orthopaedics Resting Hand Orthosis 03-2-005
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.
Time frame: Baseline, Week 4, and Week 8
Modified Ashworth Scale (MAS)
Muscle tone of the affected upper extremity will be assessed using the MAS, focusing on the finger flexors. Scores range from 0 to 4, with higher scores indicating greater muscle tone/spasticity.
Time frame: Baseline, Week 4, and Week 8
Medical Research Council Scale (MRC) - Finger Flexion
Muscle strength of the finger flexors of the affected hand will be assessed using the MRC Scale. Strength will be graded from 0 to 5, with higher scores indicating greater muscle strength. The finger flexion score will be recorded and analyzed separately from the finger extension score.
Time frame: Baseline, Week 4, and Week 8
Medical Research Council Scale (MRC) - Finger Extension
Muscle strength of the finger extensors of the affected hand will be assessed using the MRC Scale. Strength will be graded from 0 to 5, with higher scores indicating greater muscle strength. The finger extension score will be recorded and analyzed separately from the finger flexion score.
Time frame: Baseline, Week 4, and Week 8
Hand Dynamometer (JAMAR)
Grip strength of the affected hand will be measured using a JAMAR hand dynamometer. Three maximal grip attempts will be performed, and the mean value of the three measurements will be recorded in kilograms. Higher values indicate greater grip strength.
Time frame: Baseline, Week 4, and Week 8
Box and Block Test (BBT)
Gross manual dexterity of the affected upper extremity will be assessed using the BBT. The outcome will be the number of blocks successfully transferred over the partition within 60 seconds. Higher scores indicate better gross manual dexterity.
Time frame: Baseline, Week 4, and Week 8
Modified Barthel Index (MBI)
Functional independence in activities of daily living will be assessed using the MBΙ. The total score ranges from 0 to 100, with higher scores indicating greater functional independence.
Time frame: Baseline, Week 4, and Week 8
Visual Analogue Scale (VAS)
Pain intensity in the affected upper extremity will be assessed using a 100-mm VAS, ranging from 0 to 100, where 0 indicates no pain and 100 indicates the maximum perceived pain. The anatomical location of pain will also be recorded when pain is present.
Time frame: Baseline, Week 4, and Week 8
Plan to share: No — 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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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Western Macedonia