Robotic training to improve arm function in stroke and brain injury patients
A Prospective, Randomized, Open-label, Two-arms, Multi Center Feasibility Study to Evaluate the Safety and Efficacy of the PlaXtreme Device for Rehabilitation of the Hand in Post-stroke and Post TBI Participants
This study is testing a robotic training system to see if it can help people recovering from stroke and brain injuries improve their arm function better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Reuth Rehabilitation Hospital Academic / other |
| Locations | 2 sites (Ra'anana and 1 other locations) |
| Trial ID | NCT06010823 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a robotic system designed to enhance upper limb function in patients recovering from stroke and traumatic brain injury (TBI). The study employs a randomized, multi-center approach to compare the effects of robotic training with error enhancement against a control group. Participants will undergo intensive rehabilitation aimed at improving motor function through adaptive and repetitive movements. The trial seeks to determine if this innovative method can lead to better recovery outcomes for individuals with motor impairments.
Who should consider this trial
Good fit: Ideal candidates include individuals with hemiparesis due to a first stroke or TBI, who are within 14 days to 18 months post-injury and have specific cognitive and motor function scores.
Not a fit: Patients with complete paralysis of the affected side or uncontrolled epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for patients recovering from stroke and TBI.
How similar studies have performed: Previous studies have shown promise for robotic training with error enhancement, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hemiparesis due to first stroke (ischemic or hemorrhagic) or TBI; * At least 14 days after the stroke or brain injury onset; * No more than 18 months after stroke or brain injury onset; * At least 4 weeks of remaining hospitalization in inpatient or outpatient rehabilitation ward; * Voluntary provided informed consent obtained prior to any screening procedures; * Cognitive status: Montreal Cognitive Assessment (MoCA test) score ≥ 22 or Mini Mental State Examination (MMSE) score \> 24; * Upper extremity function: Score between 35 and 52 points out of 66 on the Fugl- Meyer (FG) test with sub scores of 21-32/36 for the upper arm and 14-20/24 for the wrist and hand. Exclusion Criteria: * Complete paralysis of the affected side; * Uncontrolled epilepsy; * Upper-limb pain \> 6 on 10-point Visual Analogue Scale (VAS); * Concomitant or past medical conditions that might interfere with the study (i.e. hemi spatial neglect, orthopedic problems, etc.); * Current participation in other interventional clinical study; * Fingers spasticity score on the affected hand \> 3 on Modified Ashworth Scale (MAS); * Pregnant or nursing women.
Where this trial is running
Ra'anana and 1 other locations
- Loewenstein Rehabilitation Center — Ra'anana, Israel (Recruiting)
- Reuth Rehabilitation Hospital — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Rami Mansour, MD — Reuth Rehabilitation Hospital
- Study coordinator: Rami Mansour
- Email: rami.mansour@reuth.org.il
- Phone: +972732701610
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.