Status:
UNKNOWN
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
Lead Sponsor:
Reuth Rehabilitation Hospital
Collaborating Sponsors:
Loewenstein Hospital
BioXtreme
Conditions:
Stroke
Brain Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Cerebrovascular accident \[CVA or commonly known as stroke\] and traumatic brain injury (TBI) are common causes of morbidity, and motor impairments. Many stroke and TBI patients encounter ...
Detailed Description
Background: Stroke and traumatic brain injury (TBI) are leading causes for morbidity, hospitalization, and extended injury of motor system as well as movement learning. It has been proven that roughly...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06010823
Start Date
September 1 2023
End Date
December 1 2024
Last Update
September 22 2023
Active Locations (2)
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1
Loewenstein Rehabilitation Center
Raanana, Israel
2
Reuth Rehabilitation Hospital
Tel Aviv, Israel, 6902732