Clinical trial NCT06367140: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke
Official title: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Postural balance
Electromyography
Muscle Strength
Stroke
Lead sponsor: Sahmyook University
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Kyungdong University
First posted: 2024-04-16
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Muscle Strength
timeFrame: baseline-4weeks
measure: Static Balance
timeFrame: baseline-4weeks
measure: Timed Up and Go (TUG)
timeFrame: baseline-4weeks
measure: Berg Balance Scale
timeFrame: baseline-4weeks
measure: Functional Reach Test (FRT)
timeFrame: baseline-4weeks
measure: Modified Barthel Index (MBI)
timeFrame: baseline-4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Physicla Therapy, Sahmyook University
Study officials:
affiliation: Sahmyook University
name: Jaemyoung Park, Ph.D.
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Jung hyun Kim, prof
role: STUDY_DIRECTOR
affiliation: Kyungdong University
name: Kyeongjin Lee, prof
role: STUDY_DIRECTOR
affiliation: Sahmyook University
name: Changho Song, prof
role: PRINCIPAL_INVESTIGATOR
References: