NCT07864090Not yet recruiting
Upper Extremity Orthoses Combined With Occupational Therapy in Subacute Stroke
Static and Dynamic Hand Orthoses as Adjuncts to Occupational Therapy for Upper Extremity Recovery After Subacute Stroke: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Western Macedonia
- Diseases
- Stroke
- NCT number
- NCT07864090
What you commit to
- Study type: Interventional
- Planned participants: 102
- From Oct 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous stroke.
- Botulinum toxin type A injection in the affected upper extremity within the previous 4 months or a planned injection during the study period.
Other illness
- Other significant neurological disorder affecting upper extremity function (e.g., Parkinson disease, multiple sclerosis, peripheral neuropathy).
- Severe cognitive impairment (MoCA \<11).
- Absence of upper extremity motor impairment.
- Severe orthopedic condition or anatomical deformity of the affected upper extremity that substantially limits passive movement or safe orthosis application.
- Unstable clinical condition.
- Severe or uncontrolled psychiatric disorder affecting safety or cooperation.
- Skin lesions, ulcers, or other conditions of the affected upper extremity that preclude safe orthosis use.
Other
- Severe upper extremity spasticity (MAS = 4).
- Severe pain in the affected upper extremity that limits movement and/or safe orthosis application (VAS ≥75/100 or pain that restricts passive movement/orthosis fitting).
- Inability to remain seated for approximately 45 minutes.
- Inability to cooperate with or adhere to the study protocol.
- Participation in another clinical trial or recent intervention that may influence study outcomes.
- Inability to provide valid informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ANAGENNISI Recovery and Rehabilitation Center of Thessaloniki Coordinator of this site? Confirm its status | Thermi | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.