- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386119
Investigation of the Effects of Vestibular Rehabilitation and Dynamic Neuromuscular (Dynamic)
August 4, 2026 updated by: merve yilmaz menek, Istanbul Medipol University Hospital
Investigation of the Effects of Vestibular Rehabilitation and Dynamic Neuromuscular Stabilization Exercises on Balance and Mobility in Patients With Hemiplegia
This study will aim to investigate the effects of vestibular rehabilitation, dynamic neuromuscular stabilization (DNS), and conservative rehabilitation exercises on balance and mobility in hemiplegic patients, and to compare the exercise programs with one another.
Evaluation tools include the Brunnstrom Motor Staging, Fugl-Meyer Upper Extremity Motor Function Scale, Modified Ashworth Scale, Mini-Mental State Examination, Berg Balance Scale, Stroke Impact Scale, and Timed Up and Go test.
Study Overview
Status
Completed
Detailed Description
This study will aim to investigate the effects of vestibular rehabilitation, dynamic neuromuscular stabilization (DNS), and conservative rehabilitation exercises on balance and mobility in hemiplegic patients, and to compare the exercise programs with one another.
A total of 45 hemiplegic patients will enrolled and randomized into three groups: Conventional Exercise Group (CEG, n = 15), Dynamic Neuromuscular Stabilization Group (DNSG, n = 15), and Vestibular Rehabilitation Group (VRG, n = 15).
Each group will be participated in specialized exercise programs twice a week for six weeks.
All groups will be underwent assessments before and after treatment.
Evaluation tools include the Brunnstrom Motor Staging, Fugl-Meyer Upper Extremity Motor Function Scale, Modified Ashworth Scale, Mini-Mental State Examination, Berg Balance Scale, Stroke Impact Scale, and Timed Up and Go test.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being 18 years of age or older
- Having experienced at least one stroke and presenting with hemiplegic symptoms
- Having passed at least one year since the stroke even
- Scoring at least 24 points on the Mini-Mental State Examination (MMSE)
- Being able to walk independently for at least 30 meters without assistance
- Being able to comply with and participate in the exercise program
Exclusion Criteria:
- Individuals with chronic pulmonary and/or cardiac diseases
- Presence of uncontrolled hypertension
- Conditions accompanied by peripheral nerve injury or lower motor neuron disorders
- Presence of additional neurological disorders such as ataxia, dyskinesia, or dystonia
- Severe spasticity, peripheral lesions, pressure ulcers, marked muscle atrophy, obesity, skin irritation, or use of a cardiac pacemaker
- Presence of vestibular symptoms such as vertigo or dizziness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Conventional Exercise Group
Conventional Exercise will be conducted in this group
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This group participated in Conventional Exercise programs twice a week for six weeks.
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Experimental: Group 2: Dynamic Neuromuscular Stabilization Group
Dynamic Neuromuscular Stabilization exercises will be done in this group
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This group participated in Dynamic Neuromuscular Stabilization Exercise programs twice a week for six weeks.
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Experimental: Group 3: Vestibular Rehabilitation Group
Vestibular Rehabilitation will be conducted in this group
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This group participated in Vestibular Rehabilitation programs twice a week for six weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Fugl-Meyer Assessment of Upper Extremity
Time Frame: From the beginning of treatment to the end of the 6th week
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It is a standardized, stroke-specific, performance-based outcome measure used in clinical trials to evaluate motor recovery of the upper limb.
It assesses movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand, providing a quantitative measure of motor impairment and recovery over time.
The maximum score for the arm section is 36.
During the finger-to-nose test, coordination and speed of movement are evaluated out of 6 points, while tremor, dysmetria, and speed of movement in the upper extremity are also examined in detail.
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From the beginning of treatment to the end of the 6th week
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Modified Ashworth Scale (MAS)
Time Frame: From the beginning of treatment to the end of the 6th week
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It is a widely used clinical outcome measure in clinical trials to assess spasticity by grading the resistance encountered during passive muscle stretching.
The joint is passively moved with repetitive and rapid movements, and the joint's resistance to these movements is scored.
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From the beginning of treatment to the end of the 6th week
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Mini-Mental State Examination (MMSE)
Time Frame: From the beginning of treatment to the end of the 6th week
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It is a brief, standardized cognitive screening tool used in clinical trials to assess global cognitive function, including orientation, attention, memory, language, and visuospatial abilities.
The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Scores of 24-30 indicate normal cognition, 18-23 mild cognitive impairment, and ≤17 moderate to severe cognitive impairment.
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From the beginning of treatment to the end of the 6th week
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Berg Balance Scale (BBS)
Time Frame: From the beginning of treatment to the end of the 6th week
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This is a 14-item scale that assesses a patient's ability to maintain balance for a specific period during static and various functional movements.
The scoring system ranges from 0 to 4, with 0 meaning "cannot" and 4 meaning "can do independently," and the maximum total score is 56.
A total score between 0-20 indicates a high risk of falls; between 21-40 indicates a moderate risk of falls; and between 41-56 indicates a low risk of falls.
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From the beginning of treatment to the end of the 6th week
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Stroke Impact Scale (SIS)
Time Frame: From the beginning of treatment to the end of the 6th week
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It is a stroke-specific, patient-reported outcome measure widely used in clinical trials to evaluate the perceived impact of stroke on multiple domains of health-related quality of life.
Based on the obtained score, 0 indicates no recovery, whereas 100 represents complete recovery.
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From the beginning of treatment to the end of the 6th week
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Timed Up and Go (TUG)
Time Frame: From the beginning of treatment to the end of the 6th week
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The test is a simple and widely used functional mobility assessment in clinical trials.
It measures the time required for an individual to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
Shorter completion times indicate better functional mobility and balance, and the test is commonly used to assess fall risk and mobility limitations.
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From the beginning of treatment to the end of the 6th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MERVE YILMAZ MENEK, Medipol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2026
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
August 5, 2026
Study Registration Dates
First Submitted
January 28, 2026
First Submitted That Met QC Criteria
January 28, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-3748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will be made available to other researchers upon reasonable request, if deemed necessary.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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