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NCT07864090
Upper Extremity Orthoses Combined With Occupational Therapy in Subacute Stroke
Conditions: Stroke (Subacute)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: University of Western Macedonia
Location: ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki Thermi Central 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).
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* First-ever stroke confirmed by CT or MRI (ischemic or hemorrhagic).
* Time since stroke: from Day 8 to 6 months (subacute phase of recovery).
* Presence of motor impairment in the affected upper extremity.
* Modified Ashworth Scale (MAS) score of 0-3 in the affected upper extremity.
* Montreal Cognitive Assessment (MoCA) score ≥11.
* Ability to understand and follow simple one- to two-step commands.
* Ability to remain seated for approximately 45 minutes.
* Clinically stable condition.
* Provision of written informed consent
Exclusion Criteria:
* Previous stroke.
* Other significant neurological disorder affecting upper extremity function (e.g., Parkinson disease, multiple sclerosis, peripheral neuropathy).
* Severe upper extremity spasticity (MAS = 4).
* Severe cognitive impairment (MoCA \
Source: ClinicalTrials.gov (NCT07864090). StuddyBuddy aggregates publicly available trial information.