Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants

Launched by REUTH REHABILITATION HOSPITAL · Aug 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new robotic training system designed to help improve arm and hand movement for people who have had a stroke or a traumatic brain injury (TBI). Many patients with these conditions struggle with using their arms due to weakness or difficulty controlling their movements. The robotic system aims to make therapy more effective by encouraging patients to practice their movements in a way that helps them become more accurate and fluid, ultimately enhancing their overall motor function.

To be eligible for this study, participants should be experiencing limited movement in one arm due to a stroke or TBI, and it must be at least two weeks since their injury but less than 18 months. They should also be able to follow instructions and participate actively in therapy. The study will involve 96 participants divided into two groups: one group will use the robotic system for training, while the other will receive standard therapy. Throughout the four-week program, researchers will monitor safety and how well the robotic training helps improve arm function. Participants will have assessments at the beginning, halfway through, at the end, and three months later to track their progress. This study is currently recruiting patients and aims to find out if this innovative approach can make a real difference in rehabilitation.

Gender

ALL

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.