NCT05854485

Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.

Detailed description

Individuals with chronic stroke(\> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks. Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group. The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test. Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.

Conditions

• Stroke

Interventions

Type	Name	Description
COMBINATION_PRODUCT	REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group	Participants in this group will receive multi-muscle FES during arm robotic training
COMBINATION_PRODUCT	Robot only group	Participants in this group will receive arm robotic training only

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2023-05-11
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States