Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
Stroke, Brain Injuries, Paresis
About this trial
This is an interventional treatment trial for Stroke focused on measuring Brain plasticity, Upper limb function, Robotic rehabilitation, Error augmentation or enhancement
Eligibility 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.
Sites / Locations
- Loewenstein Rehabilitation CenterRecruiting
- Reuth Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
All the participants allocated to this group will undergo rehabilitation according to each medical center's standard rehabilitation practice. In addition, the participants will receive 12 therapy sessions incorporating error enhancement (3 session a week, for a period of 4 weeks), lasting approximately 25-30 minutes each.
All participants allocated to this study group will undergo rehabilitation according to each medical center's standard rehabilitation practice.