NCT05820815

Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke

Protocol for a Single-blind Randomized Controlled Clinical Trial to Investigate the Feasibility and Safety of In-bed Self-exercise Based on Electromyography Sensor Feedback in Patients With Subacute Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this to investigate the feasibility and safety of in-bed self-exercises based on EMG-sensor feedback in subacute stroke patients. The main question is feasibility and safety. It aims to answer are: \[Pittsburgh Rehabilitation Participation Scale\] \[The number and percentage of participating sessions\] \[The number and percentage of completed sessions\] \[The number and percentage of successful sessions\] \[The mean amplitude of muscle contractions in a session\] \[The duration and percentage of participating sessions during self-exercise\] \[Rivermead motor assessment\] \[Manual muscle test\] \[brunnstrom stages of motor recovery\] \[Fugl Meyer assessment of lower extremity\] \[Berg balance scale\] \[Functional ambulation category\] \[modified Rankin scale\] \[modified Barthel index\] \[Short-form Health Survery 36 version 2\]

Detailed description

The intervention group is provided with graded exercise using the in-bed self-exercises based on EMG-sensor feedback according to muscle strength of the hemiplegic lower extremity and Brunnstrom stages of motor recovery in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	in-bed self-exercises based on EMG-sensor feedback intervention	It presents the exercise method and amount of exercise for self-exercise and performs self-exercise while receiving feedback from muscle activity during self-exercise.

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-03-25
• Completion: 2026-12-01
• First posted: 2023-04-20
• Last updated: 2025-06-02

Locations

1 site across 1 country: South Korea