Effect of Hemiparesis Side on Physiotherapy Outcomes Using the Luna EMG in Post-Ischemic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in Static and Dynamic Balance (Berg Balance Scale - BBS)
Study Overview
Brief Summary
The study evaluates the effectiveness of the Luna EMG robotic system in the rehabilitation of patients after ischemic stroke. The main objective is to assess the impact of robotic-assisted training on gait speed, balance, and bioelectrical activity of the thigh muscles (rectus femoris and biceps femoris). The study also analyzes whether the side of hemiparesis (left vs. right) influences the outcomes of physiotherapy. Participants are randomly assigned to either an experimental group receiving robotic therapy combined with standard rehabilitation or a control group receiving standard rehabilitation alone.
Detailed Description
This prospective, randomized clinical trial aims to determine the efficacy of Luna EMG-assisted training in post-stroke motor recovery. The study involves 62 patients aged 65-86 years recovering from ischemic stroke (4-15 weeks post-stroke).
Participants are randomized into two groups:
Experimental Group: Patients undergo a 4-week rehabilitation program consisting of standard physiotherapy (2 hours/day, 6 days/week) combined with robotic training using the Luna EMG device (20 minutes, 3 days/week). The robotic protocol includes reactive EMG-triggered exercises, continuous passive motion (CPM), and EMG biofeedback isometric exercises.
Control Group: Patients undergo the same standard physiotherapy program (2 hours/day, 6 days/week) but perform active resistance exercises instead of robotic training during the equivalent time slots.
The primary outcome measures include balance assessment (Timed Up and Go, Berg Balance Scale, Trunk Impairment Scale, Postural Assessment Scale for Stroke Patients) and gait speed (10-Meter Walk Test). Secondary outcomes involve the analysis of surface electromyography (sEMG) signals from the paretic lower limb muscles to evaluate changes in bioelectrical activity. The study specifically investigates comparative outcomes between patients with left-sided versus right-sided hemiparesis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 86 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of primary ischemic stroke
- •Time from stroke: 4 to 15 weeks
- •Age between 65 and 86 years
- •Limited or impaired lower limb function
- •Ability to walk 10 meters independently or with orthopedic assistance
- •Muscle strength of at least -3 on the modified Medical Research Council (MRC) scale
- •Cognitive function sufficient to understand instructions and participate in the study
- •Stable clinical status
- •Provided written informed consent
Exclusion Criteria
- •Hemorrhagic stroke or stroke in the posterior cerebral circulation
- •Lower limb spasticity greater than 1+ on the modified Ashworth Scale (MAS)
- •Functional limitations preventing the completion of selected tests
- •Recent orthopedic injuries affecting balance
- •Prior lower limb surgery
- •Sensory aphasia
- •Coexisting neurological disorders (e.g., Parkinson's disease, Huntington's disease)
- •Lack of patient cooperation or refusal to consent
Outcomes
Primary Outcomes
Change in Static and Dynamic Balance (Berg Balance Scale - BBS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The BBS is a 14-item objective measure that assesses static balance and fall risk in adult populations. Tasks include sitting to standing, standing unsupported, reaching, turning, etc. The score ranges from 0 to 56, where higher scores indicate better balance.
Change in Functional Mobility and Balance (Timed Up and Go Test - TUG)
Time Frame: Baseline and at 4 weeks (post-intervention)
The TUG test assesses mobility, balance, walking ability, and fall risk. The patient stands up from a chair, walks 3 meters, turns around, walks back, and sits down. The time taken to complete the task is measured in seconds. Lower time indicates better functional mobility.
Change in Trunk Control (Trunk Impairment Scale - TIS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The TIS evaluates motor impairment of the trunk after stroke. It assesses static sitting balance, dynamic sitting balance, and coordination. Higher scores indicate better trunk control and stability.
Change in Postural Control (Postural Assessment Scale for Stroke Patients - PASS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The PASS assesses postural control in patients after stroke. It measures the ability to maintain and change lying, sitting, and standing postures. Higher scores indicate better postural performance.
Change in Gait Speed (10-Meter Walk Test - 10MWT)
Time Frame: Baseline and at 4 weeks (post-intervention)
Assesses walking speed over a short distance. The patient walks 10 meters, and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. The result is calculated in meters per second (m/s). Higher speed indicates better gait performance.
Secondary Outcomes
- Change in Bioelectrical Activity of the Biceps Femoris Muscle(Baseline and at 4 weeks (post-intervention))
- Change in Bioelectrical Activity of the Rectus Femoris Muscle(Baseline and at 4 weeks (post-intervention))
- Change in Bioelectrical Activity of the Biceps Femoris Muscle(Baseline and at 4 weeks (post-intervention))