Trial results for a study investigating the Rehabilitation Robotic System ReHand in Stroke patients were posted on ClinicalTrials.gov on 2025-08-05, showing that the intervention group achieved a median Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 45.0 compared to 36.0 in the control group.
Background
Stroke often leads to significant functional deficits, particularly affecting upper extremity function and overall independence. Rehabilitation is crucial for recovery, and new technologies like robotic systems aim to enhance these efforts. The ReHand system was investigated to assess its efficacy in improving patient recovery after a cerebral stroke.
Trial design
This completed study, identified as Phase NA, enrolled 120 participants with Stroke, Rehabilitation, and Robotic Exoskeleton. The trial aimed to investigate the efficacy of the ReHand rehabilitation system for the recovery of patients after a stroke. Participants were randomized into an intervention group receiving the ReHand robotic system alongside standard rehabilitation, and a control group receiving standard rehabilitation only. The study assessed functional state using the Barthel Index and Functional Independence Measure (FIM) scale, and neurological deficit using the National Institutes of Health Stroke Scale (NIHSS) and the Frenchay Arm Test. Additional measures included the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Modified Wolf Motor Function Test (mWMFT).
Key results
The trial results compared the outcomes between the intervention group (Robot Rehand + Standard Rehabilitation) and the control group (Standard Rehabilitation Only) across several key assessments:
- For the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), the intervention group had a median score of 45.0, compared to 36.0 for the control group.
- On the Barthel Index (BI), the intervention group achieved a median score of 70.0, while the control group had a median score of 55.0.
- The Functional Independence Measure Scale (FIM) showed a median score of 76.0 for the intervention group and 61.0 for the control group.
- For the National Institutes of Health Stroke Scale (NIHSS), the intervention group had a median score of 4.0, which was lower than the control group's median score of 6.5.
- The Frenchay Arm Test showed a mean score of 3.0 for the intervention group, compared to 2.0 for the control group.
- The Modified Wolf Motor Function Test (mWMFT) indicated a median score of 53.0 for the intervention group and 44.0 for the control group.
What this means
The posted results suggest that incorporating the ReHand robotic system into standard rehabilitation for stroke patients may lead to improved functional and neurological outcomes. Across multiple assessment scales, including the Fugl-Meyer Assessment for Upper Extremity, Barthel Index, Functional Independence Measure, and Modified Wolf Motor Function Test, patients in the intervention group consistently demonstrated higher median or mean scores, indicating better recovery and independence. A lower median NIHSS score in the intervention group also suggests reduced neurological deficit. These findings imply that robotic exoskeleton systems like ReHand could be a valuable addition to post-stroke rehabilitation protocols, potentially enhancing recovery for individuals affected by stroke.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06937346, titled "Rehabilitation Robotic System ReHand", were posted on 2025-08-05 on clinicaltrials.gov.