RecruitingNot ApplicableNCT05820815

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


Sponsor

Seoul National University Hospital

Enrollment

24 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

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: \[Pittsburgh Rehabilitation Participation Scale\] \[The number and percentage of participating sessions\] \[The number and percentage of completed sessions\] \[The number and percentage of successful sessions\] \[The mean amplitude of muscle contractions in a session\] \[The duration and percentage of participating sessions during self-exercise\] \[Rivermead motor assessment\] \[Manual muscle test\] \[brunnstrom stages of motor recovery\] \[Fugl Meyer assessment of lower extremity\] \[Berg balance scale\] \[Functional ambulation category\] \[modified Rankin scale\] \[modified Barthel index\] \[Short-form Health Survery 36 version 2\]


Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • years and older
  • the onset of the stroke is less than 3months ago
  • Lower extremity weakness due to stroke (MMT =< 4 grade)
  • Modified Rankine Scale 2-5 points
  • Cognitive ability to follow commands

Exclusion Criteria5

  • stroke recurrence
  • other neurological abnormalities (e.g. parkinson's disease).
  • severely impaired cognition
  • serious and complex medical conditions(e.g. active cancer)
  • cardiac pacemaker or other implanted electronic system

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Interventions

DEVICEin-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.


Locations(1)

Seoul National University Hospital

Seoul, Jongno, South Korea

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NCT05820815


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