Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke

Sahmyook University

Status: Completed

Conditions: Stroke

Treatments: Device: general cycling training; Device: EMG-triggered CIMCT device

Study type: Interventional

Funder types: Other

Identifiers

NCT06367140

SYU 2021-06-001-002

Details and patient eligibility

About

The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki.

Full description

This research evaluates the effectiveness of EMG-triggered CIMCT in improving balance, lower extremity strength, and activities of daily living (ADLs) for chronic stroke patients with hemiplegia, a condition typically resulting from a stroke. The study's scope includes:

Duration and Type: A four-week, single-blind randomized controlled trial. Participants: Chronic stroke patients diagnosed with stroke-induced hemiplegia for more than six months, possessing specific levels of cognitive and motor recovery.

Interventions: Participants are randomly assigned to one of two groups:

CIMCT Group: Utilizes an EMG-triggered Constraint-Induced Movement Therapy device designed to engage the affected lower extremity actively.

GCT Group: Engages in activity using a standard stationary bicycle without EMG facilitation.

Enrollment: 58 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic stroke-induced hemiplegia
• Diagnosed with stroke for more than 6 months
• Achieving a minimum score of 24 points on the Mini-Mental State Examination
• Demonstrating motor recovery at or above level 3 according to the Brunnstrom stages

Exclusion criteria

• Individuals with neurological damage unrelated to their stroke
• Orthopedic issues such as fractures or peripheral nervous system damage in the lower limbs
• Visual or auditory impairments
• Those who had experienced more than one stroke
• Those with less than an 80% participation rate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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58 participants in 2 patient groups

constraint-induced movement therapy groups

Experimental group

Description:

The device utilized EMG sensors to collect signals from the leg muscles, which then controlled the cycling motion. This group underwent specific training sessions designed to enhance muscle activation on the affected side by inducing voluntary contractions through cycling, with the aim of improving muscle strength, balance, and activities of daily living. The sessions included a structured regimen of warm-up, active cycling with therapist-guided acceleration based on muscle activation, and cool-down periods, conducted under supervision for safety and effectiveness.

Treatment:

Device: EMG-triggered CIMCT device

general cycling training groups

Sham Comparator group

Description:

This group followed a similar session structure to the CIMCT group, including warm-up, cycling at a comfortable pace, and cool-down phases, but without the targeted muscle activation component.

Treatment:

Device: general cycling training