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StrokeNCT07143630

Abdominal Electrical Stimulation for Balance and Muscle Thickness in Stroke Patients

A study testing Neuromuscular Electrical Stimulation and Core Stabilization Exercises in people with Stroke, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Stroke
What is being tested?
Neuromuscular Electrical Stimulation and Core Stabilization Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Aug 2025to 11 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Başakşehir Çam and Sakura City Hospital

    Istanbul, 34480

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Abdominal Electrical Stimulation on Balance and Ultrasound-Measured Muscle Thickness in Stroke Patients: A Prospective Randomized Controlled Trials

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.

Read the 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.

Conditions
Stroke
Being tested
Neuromuscular Electrical Stimulation, Core Stabilization Exercises
Keywords
postural balance, balance impairment, rehabilitation, neuromuscular electrical stimulation, abdominal muscle
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical StimulationDevice

    Also called Chattanooga multichanel stimulator

    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 ExercisesBehavioural

    Also called Trunk stabilization training

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

Study groups in NCT07143630
Study groupRoleWhat they receive
NMES + Core Stabilization ExercisesExperimentalNot described
Receives: Device: Neuromuscular Electrical Stimulation; Behavioral: Core Stabilization Exercises
Core Stabilization Exercises OnlyActive comparatorNot described
Receives: Behavioral: Core Stabilization Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and after 15 sessions (≈3 weeks)

  2. Abdominal Muscle Thickness (Ultrasound)

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

    Measured: Baseline and after 15 sessions (≈3 weeks)]

Secondary outcomes (6)

  1. Trunk Control (Trunk Control test)

    Measured: Baseline and after 15 sessions (≈3 weeks)]

  2. Fear of Falling (Visual Analog Scale - VAS)

    Fear of falling will be evaluated using a Visual Analog Scale (VAS; score range: 0-10 cm, where 0 = no fear and 10 = maximum fear). Higher scores indicate greater fear of falling.

    Measured: Baseline and after 15 sessions (≈3 weeks)]

  3. Change in Postural Control (Postural Assessment Scale for Stroke Patients)

    Postural control will be assessed using the Postural Assessment Scale for Stroke Patients (PASS; score range: 0-36). Higher scores indicate better postural control, lower scores indicate worse control.

    Measured: Baseline and after 15 sessions (≈3 weeks)]

  4. Functional Ambulation (Functional Ambulation Classification - FAC)

    Ambulation will be measured using the Functional Ambulation Classification (FAC; score range: 0-5). Higher scores indicate better functional ambulation.

    Measured: Baseline and after 15 sessions (≈3 weeks)]

  5. Mobility (Timed Up and Go Test - TUG)

    Mobility will be assessed using the Timed Up and Go Test (TUG; measured in seconds). Lower times indicate better mobility, higher times indicate worse mobility.

    Measured: Baseline and after 15 sessions (≈3 weeks)]

  6. Motor Recovery (Brunnstrom Stages)

    Motor recovery will be assessed using Brunnstrom Stages of Motor Recovery (score range: Stage 1-6). Higher stages indicate better motor recovery.

    Measured: Baseline and after 15 sessions (≈3 weeks)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start28 Aug 2025
  3. Primary completion11 Apr 2026
  4. Study completion11 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143630
Sponsor's protocol ID
26.02.2025.79
Status last verified
Aug 2025
First submitted
20 Aug 2025
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation and Core Stabilization Exercises in people with Stroke, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Balance Performance (Berg Balance Scale) (time frame: Baseline and after 15 sessions (≈3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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