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

Seoul National University

Status: Enrolling

Conditions: Stroke

Treatments: Device: in-bed self-exercises based on EMG-sensor feedback intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05820815

20220150017 (Other Identifier)

0720222116

Details and patient eligibility

About

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]

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

in-bed self-exercises based on EMG-sensor feedback intervention

Experimental group

Description:

Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training. Additional in-bed self-exercises based on EMG-sensor feedback with conventional rehabilitation.

Treatment:

Device: in-bed self-exercises based on EMG-sensor feedback intervention

Conventional rehabilitation

No Intervention group

Description:

Conventional rehabilitation corresponds to general rehabilitation for lower extremity motor function in stroke patients and is mainly performed according to functional mobility with a range of motion. This includes lying down, standing, walking, and balance training.