NCT07386119

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

HemiplegiaVestibular RehabilitationDynamic Neuromuscular StabilizationBalanceMobility

Outcome Measures

Primary Outcomes (6)

  • The Fugl-Meyer Assessment of Upper Extremity

    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.

    From the beginning of treatment to the end of the 6th week

  • Modified Ashworth Scale (MAS)

    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.

    From the beginning of treatment to the end of the 6th week

  • Mini-Mental State Examination (MMSE)

    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.

    From the beginning of treatment to the end of the 6th week

  • Berg Balance Scale (BBS)

    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.

    From the beginning of treatment to the end of the 6th week

  • Stroke Impact Scale (SIS)

    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.

    From the beginning of treatment to the end of the 6th week

  • Timed Up and Go (TUG)

    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.

    From the beginning of treatment to the end of the 6th week

Study Arms (3)

Group 1: Conventional Exercise Group

EXPERIMENTAL

Conventional Exercise will be conducted in this group

Other: Conventional Exercise programs

Group 2: Dynamic Neuromuscular Stabilization Group

EXPERIMENTAL

Dynamic Neuromuscular Stabilization exercises will be done in this group

Other: Dynamic Neuromuscular Stabilization

Group 3: Vestibular Rehabilitation Group

EXPERIMENTAL

Vestibular Rehabilitation will be conducted in this group

Other: Vestibular Rehabilitation Group

Interventions

This group participated in Conventional Exercise programs twice a week for six weeks.

Group 1: Conventional Exercise Group

This group participated in Dynamic Neuromuscular Stabilization Exercise programs twice a week for six weeks.

Group 2: Dynamic Neuromuscular Stabilization Group

This group participated in Vestibular Rehabilitation programs twice a week for six weeks.

Group 3: Vestibular Rehabilitation Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Yoon HS, Cha YJ, You JSH. Effects of dynamic core-postural chain stabilization on diaphragm movement, abdominal muscle thickness, and postural control in patients with subacute stroke: A randomized control trial. NeuroRehabilitation. 2020;46(3):381-389. doi: 10.3233/NRE-192983.

Related Links

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MERVE YILMAZ MENEK

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor will be masked in the assesment part in the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

January 17, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will be made available to other researchers upon reasonable request, if deemed necessary.

Locations