Abdominal Electrical Stimulation for Balance and Muscle Thickness in Stroke Patients

NCT ID: NCT07143630

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NMES + Core Stabilization Exercises

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type 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.

Core Stabilization Exercises

Intervention Type 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.

Core Stabilization Exercises Only

Group Type ACTIVE_COMPARATOR

Core Stabilization Exercises

Intervention Type 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.

Interventions

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Neuromuscular Electrical Stimulation

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.

Intervention Type DEVICE

Core Stabilization Exercises

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Chattanooga multichanel stimulator Trunk stabilization training

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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tuba sarıkaya

Resident in Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuba SARIKAYA

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

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Başakşehir Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tuba SARIKAYA

Role: CONTACT

+90 554 728 00 96

Ümit YALÇIN

Role: CONTACT

Facility Contacts

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Tuba SARIKAYA

Role: primary

Ümit YALÇIN

Role: backup

Other Identifiers

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26.02.2025.79

Identifier Type: -

Identifier Source: org_study_id

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