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

Stroke Clinical Trial

Official title:

Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06367140
• Other study ID #: SYU 2021-06-001-002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Physicla Therapy, Sahmyook University	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Sahmyook University	Kyungdong University, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength	A manual muscle tester (Model 01163, Lafayette, USA, 2003) was used to evaluate lower extremity muscle strength in this study. The knee extensors, knee flexors, dorsiflexors, and plantar flexors, which are primarily responsible for the pedaling motion, were assessed. Moreover, both sides were evaluated.	baseline-4weeks
Primary	Static Balance	This study utilized a commercially available GB300 (Metitur Ltd., Jyvaskyla, Finland) posture measurement system for posture measurement, which included a movable triangular-shaped platform and a ruler that displayed the position of the feet. The aforementioned system was useful for analyzing balance problems and the effectiveness of rehabilitation. The posture management system is also commonly used to assess balance ability in athletes, older individuals, patients with stroke, and patients with hemiplegia. The sampling frequency was set at 50 Hz. The participants stood with their eyes open and facing forward for 30 s while fixed to the equipment; this was repeated three times. Subsequently, they stood in the same position with their eyes closed and facing forward for 30 s for three additional measurements.	baseline-4weeks
Primary	Timed Up and Go (TUG)	The Timed up-and-go (TUG) test was used to assess the balance ability in this study. In the test, the participant sits in a chair with armrests, rises from the chair at the same time as the word "start" is spoken, walks at the most stable and comfortable speed to a point 3 m in front of them, and then returns and measures the time to sit down in the chair. It has a high intra-rater reliability (r=.99) and inter-rater reliability (r=.98). The raters performed three measurements using a stopwatch and recorded the average value.	baseline-4weeks
Primary	Berg Balance Scale	The Berg Balance Scale is used to assess functional balance in a wide range of participants, including older individuals at a high risk of falling and patients with acute and chronic diseases. Moreover, Berg Balance Scale is a functional balance test method that considers three aspects of functional balance: postural maintenance, postural control by manual exercise, and response to external perturbations. these activities are scored from 0 to 4, with 0 being the worst and 4 being the best performance of independent tasks. The maximum total score is 56 points. A lower score suggests impaired stability.	baseline-4weeks
Primary	Functional Reach Test (FRT)	The functional reach test (FRT) assesses the limits of physical stability and measures dynamic balance and flexibility while the participant performs a functional task. The FRT measures the maximum distance a participant can extend their arm forward from a standing position while maintaining fixed support. The distance was measured in centimeters using a Laser Rangefinder (DLE50, BOSCH, Germany). The results represented the averages of three consecutive measurements. The reliability of this test was 0.89.	baseline-4weeks
Primary	Modified Barthel Index (MBI)	The modified Barthel index (MBI) developed by was used to measure the performance of daily living behaviors. The MBI consists of 10 items: self-care, bathing, feeding, climbing stairs, dressing, bowel control, bladder control, walking, and transferring. The scoring system ranged from 5 to 15, with a score of 100 if all items could be performed completely independently. The inter-rater reliability was 0.93-0.98, and the Cronbach's alpha value was 0.84.	baseline-4weeks