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

NCT ID: NCT06367140

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

constraint-induced movement therapy groups

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.

Group Type: EXPERIMENTAL

EMG-triggered CIMCT device

Intervention Type: DEVICE

The study tested an EMG-triggered CIMCT device for stroke rehab, involving EMG sensors, a stationary bike, and a control unit displaying muscle activity. The protocol included warm-up, therapist-guided exercises, and cool-down, performed under supervision.

general cycling training groups

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.

Group Type: SHAM_COMPARATOR

general cycling training

Intervention Type: DEVICE

The training aimed to improve overall physical fitness and potentially aid in stroke recovery through regular cycling activity, conducted under supervision to ensure participant safety and adherence to the protocol.

Interventions

EMG-triggered CIMCT device

The study tested an EMG-triggered CIMCT device for stroke rehab, involving EMG sensors, a stationary bike, and a control unit displaying muscle activity. The protocol included warm-up, therapist-guided exercises, and cool-down, performed under supervision.

Intervention Type: DEVICE

general cycling training

The training aimed to improve overall physical fitness and potentially aid in stroke recovery through regular cycling activity, conducted under supervision to ensure participant safety and adherence to the protocol.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Kyungdong University

OTHER

Sponsor Role: collaborator

Sahmyook University

OTHER

Sponsor Role: lead

Responsible Party

Changho Song

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaemyoung Park, Ph.D.

Role: STUDY_CHAIR

Sahmyook University

Jung hyun Kim, prof

Role: STUDY_DIRECTOR

Seoul National University Hospital

Kyeongjin Lee, prof

Role: STUDY_DIRECTOR

Kyungdong University

Changho Song, prof

Role: PRINCIPAL_INVESTIGATOR

Sahmyook University

Locations

Department of Physicla Therapy, Sahmyook University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SYU 2021-06-001-002

Identifier Type: -

Identifier Source: org_study_id