Effects of Abdominal Electrical Stimulation on Balance and Ultrasound-Measured Muscle Thickness in Stroke Patients: A Prospective Randomized Controlled Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Change in Balance Performance (Berg Balance Scale)
Study Overview
Brief Summary
Stroke is a leading cause of balance impairment and trunk muscle weakness, which restricts independence in daily activities. Neuromuscular electrical stimulation (NMES) is a safe rehabilitation method to activate muscles. This study will evaluate the effects of NMES applied to the abdominal muscles on balance and ultrasound-measured muscle thickness in stroke patients. The findings may provide evidence for new treatment strategies to enhance trunk function and improve quality of life after stroke.
Detailed Description
Stroke is a leading cause of long-term disability and frequently results in impaired balance and trunk muscle weakness, limiting independence in daily life. Abdominal muscles are essential for postural stability, and their weakness may adversely affect mobility and functional outcomes in stroke patients. Neuromuscular electrical stimulation (NMES) is a safe rehabilitation method used to promote muscle contraction and improve strength. While NMES has shown positive effects on limb muscles, its impact on abdominal muscles and balance remains insufficiently studied.
In this prospective randomized controlled trial, participants will be randomly allocated into two groups. The control group will perform core stabilization exercises, while the intervention group will receive core stabilization exercises combined with abdominal NMES. Balance will be assessed using validated clinical scales, and abdominal muscle thickness will be measured by ultrasound. The study aims to determine the additional effects of abdominal NMES on balance, trunk control, and functional recovery in stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 65 years.
- •At least 1 month since the onset of stroke.
- •Ability to maintain sitting balance without support.
- •Ability to stand with or without support.
- •Voluntary agreement to participate in the study (signed informed consent).
Exclusion Criteria
- •History of hemiplegia on the contralateral side of the body.
- •Medically unstable condition.
- •History of orthopedic or neurological disease that may cause balance impairment.
- •Presence of balance problems prior to stroke.
- •Body mass index (BMI) ≥ 35
- •Presence of a cardiac pacemaker.
- •Diagnosis of malignancy.
- •Epilepsy.
- •Pregnancy.
- •Open wound or infection in the area where stimulation will be applied.
- •Lack of cooperation or inability to follow instructions.
Arms & Interventions
NMES + Core Stabilization Exercises
Intervention: Neuromuscular Electrical Stimulation (Device)
NMES + Core Stabilization Exercises
Intervention: Core Stabilization Exercises (Behavioral)
Core Stabilization Exercises Only
Intervention: Core Stabilization Exercises (Behavioral)
Outcomes
Primary Outcomes
Change in Balance Performance (Berg Balance Scale)
Time Frame: Baseline and after 15 sessions (≈3 weeks)
Balance will be assessed using the Berg Balance Scale (BBS; maximum score: 56, minimum score: 0). Higher scores indicate better balance, lower scores indicate worse balance.
Abdominal Muscle Thickness (Ultrasound)
Time Frame: Baseline and after 15 sessions (≈3 weeks)]
Abdominal muscle thickness will be measured in millimeters by ultrasound at rest. Higher values indicate greater muscle thickness.
Change in Balance Performance (Berg Balance Scale)
Time Frame: Baseline and after 15 sessions (≈3 weeks)
Balance will be assessed using the Berg Balance Scale (BBS; maximum score: 56, minimum score: 0). Higher scores indicate better balance, lower scores indicate worse balance.
Abdominal Muscle Thickness (Ultrasound)
Time Frame: Baseline and after 15 sessions (≈3 weeks)]
Abdominal muscle thickness will be measured in millimeters by ultrasound at rest. Higher values indicate greater muscle thickness.
Secondary Outcomes
- Trunk Control (Trunk Control test)(Baseline and after 15 sessions (≈3 weeks)])
- Fear of Falling (Visual Analog Scale - VAS)(Baseline and after 15 sessions (≈3 weeks)])
- Functional Ambulation (Functional Ambulation Classification - FAC)(Baseline and after 15 sessions (≈3 weeks)])
- Mobility (Timed Up and Go Test - TUG)(Baseline and after 15 sessions (≈3 weeks)])
- Motor Recovery (Brunnstrom Stages)(Baseline and after 15 sessions (≈3 weeks)])
- Change in Postural Control (Postural Assessment Scale for Stroke Patients)(Baseline and after 15 sessions (≈3 weeks)])
- Trunk Control (Trunk Control test)(Baseline and after 15 sessions (≈3 weeks)])
- Fear of Falling (Visual Analog Scale - VAS)(Baseline and after 15 sessions (≈3 weeks)])
- Change in Postural Control (Postural Assessment Scale for Stroke Patients)(Baseline and after 15 sessions (≈3 weeks)])
- Functional Ambulation (Functional Ambulation Classification - FAC)(Baseline and after 15 sessions (≈3 weeks)])
- Mobility (Timed Up and Go Test - TUG)(Baseline and after 15 sessions (≈3 weeks)])
- Motor Recovery (Brunnstrom Stages)(Baseline and after 15 sessions (≈3 weeks)])
Investigators
tuba sarıkaya
Resident in Physical Medicine and Rehabilitation
Başakşehir Çam & Sakura City Hospital