Protocol for a single-blind randomized controlled clinical trial to investigate the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke.

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Electromyography*/methods ; Exercise Therapy*/methods ; Stroke*/physiopathology ; Stroke*/therapy ; Stroke Rehabilitation*/methods ; Stroke Rehabilitation*/instrumentation ; Feedback*; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Feasibility Studies ; Pilot Projects ; Single-Blind Method

Background: The dosage and intensity of physical therapy are crucial factors influencing the motor recovery of the hemiplegic lower limb in patients with subacute stroke. Biofeedback using wearable sensors may provide opportunities for patients with stroke to effectively guide self-exercises with monitoring of muscular activities in hemiplegic lower limbs. This study aims to explore the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke.
Methods: This is a pilot randomized controlled trial comparing conventional physical therapy with additional in-bed self-exercises based on electromyography sensor feedback and conventional physical therapy alone. The interventions will be adjusted according to the muscle strength and Brunnstrom recovery stage in the hemiplegic lower limbs. The primary outcome measure is the Pittsburgh Rehabilitation Participation Scale. The secondary outcome measures include the number and percentage of participating sessions, number and percentage of effortful sessions, number and percentage of successful sessions, mean amplitude of muscle contractions in a session, duration and percentage of participating sessions during self-exercises, Rivermead Motor Assessment, Manual Muscle Test, Brunnstrom recovery stage, Fugl-Meyer assessment, Berg Balance Scale, Functional Ambulation Category, modified Rankin scale, and Short-Form Health Survey 36 version 2.
Results: The results will be described in future studies.
Conclusion: This clinical trial will estimate the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke. If the expected results are achieved in this study, stroke rehabilitation methods will be enriched.
Trial Registration: clinicialtrials.gov, NCT05820815.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: JH Kim, BM Oh, JT Han, DH Kang, and WH Lee have applied for a patent on the method and system of EMG-based in-bed rehabilitation for stroke patients.
(Copyright: © 2024 Kim et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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ClinicalTrials.gov NCT05820815

Date Created: 20250108 Date Completed: 20250108 Latest Revision: 20250115

20250115

PMC11684591

10.1371/journal.pone.0310178

39775073