Abdominal Electrical Stimulation for Balance and Muscle Thickness in Stroke Patients

NCT07143630 | Active Not Recruiting

• 1 other identifier: 26.02.2025.79
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

postural balance; balance impairment; rehabilitation; neuromuscular electrical stimulation; abdominal muscle

Outcome Measures

Primary Outcomes (2)

• Change in Balance Performance (Berg Balance Scale)

  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.

  Baseline and after 15 sessions (≈3 weeks)

• Abdominal Muscle Thickness (Ultrasound)

  Abdominal muscle thickness will be measured in millimeters by ultrasound at rest. Higher values indicate greater muscle thickness.

  Baseline and after 15 sessions (≈3 weeks)]

Secondary Outcomes (6)

• 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)]

Study Arms (2)

NMES + Core Stabilization Exercises

EXPERIMENTAL

Device: Neuromuscular Electrical Stimulation; Behavioral: Core Stabilization Exercises

Core Stabilization Exercises Only

ACTIVE COMPARATOR

Behavioral: Core Stabilization Exercises

Interventions

Neuromuscular Electrical Stimulation DEVICE

NMES will be applied to the abdominal muscles using a multichannel stimulator. Each session will last approximately 20 minutes, administered 5 times per week for a total of 15 sessions, in addition to core stabilization exercise program performed with the same frequency.

Also known as: Chattanooga multichanel stimulator

NMES + Core Stabilization Exercises

Core Stabilization Exercises BEHAVIORAL

Participants will perform a structured core stabilization exercise program. The program will be administered 5 times per week for a total of 15 sessions.

Also known as: Trunk stabilization training

Core Stabilization Exercises Only; NMES + Core Stabilization Exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tuba SARIKAYA

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Physical Medicine and Rehabilitation

Model Details: This study is a prospective, randomized, parallel-group trial. Stroke patients will be randomly assigned to one of two groups: (1) an intervention group receiving neuromuscular electrical stimulation (NMES) applied to the abdominal muscles in addition to core stabilization exercises, or (2) a control group performing only core stabilization exercises.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 28, 2025
• Primary Completion: April 11, 2026
• Study Completion: April 11, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)