Extra high-dose arm and hand training early after stroke to improve upper-limb recovery
Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients
We will try extra technology-based arm and hand training in people 1–6 weeks after stroke to help them regain upper-limb movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adi Negev-Nahalat Eran Academic / other |
| Locations | 2 sites (Ofakim and 1 other locations) |
| Trial ID | NCT07056049 on ClinicalTrials.gov |
What this trial studies
This interventional program enrolls adults 1–6 weeks after an ischemic or hemorrhagic stroke who retain some active shoulder and wrist/finger movement. Participants receive additional technology-based upper-extremity training for 120 minutes per day, five days a week, for four weeks on top of usual care. Outcomes are measured at baseline and followed for a total study duration of six months to track motor recovery. The protocol targets high-dosage, high-intensity repetitive practice during the subacute period when neuroplasticity may be greatest.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) 1–6 weeks after a confirmed ischemic or hemorrhagic stroke with at least 20° of active shoulder flexion, some wrist or finger movement, ability to give informed consent, and without severe spasticity, painful shoulder, unstable medical conditions, or major communication/cognitive deficits.
Not a fit: Patients with severe spasticity or non-neural loss of range of motion, a painful shoulder that limits reaching, major cognitive or communication impairments, or unstable medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, patients could regain more arm and hand function and achieve greater independence in daily activities.
How similar studies have performed: Animal studies and some human trials suggest intensive early training can improve motor recovery, but clinical evidence is not yet conclusive and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI * First-ever stroke or previous stroke with no upper extremity weakness * 1 week ≤ Time after stroke onset ≤ 6 weeks * Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement * Ability to provide inform consent Exclusion Criteria: * A painful shoulder limiting an active forward reach * Severe spasticity or non-neural loss of range of motion * Cognitive or communication impairments as determined by the clinical team Unstable medical conditions
Where this trial is running
Ofakim and 1 other locations
- Adi Negev-Nahalat Eran — Ofakim, Israel (Not_yet_recruiting)
- Adi Negev-Nahalat Eran — Ofakim, Israel (Recruiting)
Study contacts
- Principal investigator: Lior Shmuelof, Prof. — Ben-Gurion University of the Negev
- Study coordinator: Gil Meir
- Email: gilmeir10@gmail.com
- Phone: +972 0548340307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.