Chronic StrokeNCT07863271
The Effect of Local Vibration Therapy Combined With a Structured Exercise Program on Functional Status in Individuals With Chronic Stroke
A study testing Structured Exercise Group(YEG) and Conventional Exercise Group(GEG) in people with Chronic Stroke, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if adding neck vibration to structured exercises improves balance and movement in adults with long-term stroke. The main questions it aims to answer are: Does this exercise and vibration program improve balance, walking, and daily living skills? Is structured exercise with… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Structured Exercise Group(YEG) and Conventional Exercise Group(GEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 80 years
- Diagnosis of ischemic stroke
- Post-stroke duration of at least 12 months (chronic stroke)
- Willingness to participate and provision of written informed consent
- Not currently participating in any ongoing physiotherapy or rehabilitation program
Who cannot join
- Presence of any neurological, orthopedic, or sensory condition other than stroke that affects postural balance (e.g., vestibular neuritis, benign paroxysmal positional vertigo [BPPV], uncorrected visual impairments)
- History of more than two stroke events
- Severe spasticity defined as a Modified Ashworth Scale score of ≥ 3 in the affected extremities
- Severe functional dependence defined as a Barthel Index score of ≤ 61
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeni Huzur Medical Center
Istanbul, Istanbul, 34403
About this study
The goal of this clinical trial is to learn if adding neck vibration to structured exercises improves balance and movement in adults with long-term stroke. The main questions it aims to answer are:
Does this exercise and vibration program improve balance, walking, and daily living skills?
Read more
Is structured exercise with neck vibration more effective than traditional exercise with neck vibration?
Researchers will compare a structured exercise group to a traditional exercise group to see if one works better.
Participants will:
Complete exercise sessions 2 days a week for 12 weeks
Receive 5 minutes of mild neck vibration after each exercise session
Take balance, walking, and daily activity tests at the start and end of the study
Read the detailed description
Stroke can lead to long-term difficulties with balance, walking, and everyday physical activities. This study evaluates and compares two different exercise programs, both combined with local cervical vibration, to support functional recovery in adults with chronic stroke.
Participants are randomly assigned to one of two groups:
Structured Exercise Group(YEG): Participants perform a specialized regimen that includes gaze stabilization, Cawthorne-Cooksey exercises, balance training, posture control, gait practice, and cervical and core strengthening.
Stroke can lead to long-term difficulties with balance, motor function, and everyday physical activities. This study evaluated and compared the effects of two different exercise programs (structured exercise versus traditional exercise), both combined with local cervical vibration, on balance, motor recovery, and functional performance in individuals with chronic stroke.
A total of 34 participants with chronic stroke (aged 40-80 years, with a stroke onset of at least 12 months) were randomly allocated into two equal groups:
Structured Exercise Group (n=17): Participants completed a comprehensive program consisting of gaze stabilization exercises, Cawthorne-Cooksey exercises, balance training, posture control, gait training, and cervical/core strengthening exercises.
Conventional Exercise Group (n=17)(GEG): Participants completed standard stroke rehabilitation exercises, including passive/active range of motion exercises, muscle stretching, strengthening, and gait training for both upper and lower extremities.
In both groups, 5 minutes of local vibration was applied to the cervical region immediately after each exercise session. Interventions were conducted 2 days per week for 12 weeks.
Participants were evaluated at baseline (pre-treatment) and at post-intervention (Week 12) using the following standardized outcome measures:
Fugl-Meyer Assessment of Lower Extremity(FMA-LE): Evaluates lower limb motor recovery.
Berg Balance Scale (BBS): Evaluates static and dynamic balance capacity.
Functional Reach Test (FRT): Measures margin of stability and forward reach limits.
Modified Ashworth Scale (MAS): It is used for the assessment of spasticity.
Timed Up and Go Test (TUG): It is used for measuring balance and mobility.
Functional Independence Measure (FIM) : Evaluates independence in daily living activities.
Stroke Impact Scale(SIS) : Measures health status and stroke-specific quality of life.
Barthel Index(BI): It is used for the assessment of activities of daily living.
- Conditions
- Chronic Stroke
- Being tested
- Structured Exercise Group(YEG), Conventional Exercise Group(GEG)
- Keywords
- stroke, local vibration, structured exercise, balance, motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise Group(YEG)Behavioural
Also called YEG
The Structured Exercise Group (n=17) received gaze stabilization exercises, Cawthorne-Cooksey exercises, mat activities, gait training, balance board training, tandem walking, head rotations during dynamic walking, chin-tuck exercise, cervical isometric exercises, core stabilization exercise, and posture training in front of a mirror. Each exercise was performed for 1 set of 10 repetitions, except for balance board training, which was applied as 3 repetitions of 10 seconds. Following the completion of all exercises, a 5-minute local vibration application was administered to the cervical region. The treatment program was scheduled as 2 days per week.
Conventional Exercise Group(GEG)Behavioural
Also called GEG
The Conventional Exercise Group (n=17) received range of motion exercises for the lower extremity, stretching exercises, gait training, and straight leg raise exercises. For the upper extremity, active/active-assisted/passive range of motion exercises, ball-squeezing exercise, multi-directional exercises with a bottle, reaching exercises, and weight-shifting exercises were administered. Each exercise was performed as 1 set of 10 repetitions. Following the completion of all exercises, a 5-minute local vibration application was administered to the cervical region. The treatment program was scheduled as 2 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Exercise Group(GEG) | Active comparator | The Conventional Exercise Group(GEG) (n=17) received range of motion, stretching, strengthening, and gait exercises targeting the upper and lower extremities. Following the exercise sessions, this groups received 5 minutes of local vibration to the cervical region, and the treatment program was conducted 2 days a week. Receives: Behavioral: Conventional Exercise Group(GEG) |
| Structured Exercise Group(YEG) | Experimental | The Structured Exercise Group(YEG) (n=17) received a program including gaze stabilization exercises, Cawthorne-Cooksey exercises, balance, posture, gait, and cervical/core exercises; Following the exercise sessions, this groups received 5 minutes of local vibration to the cervical region and the treatment program was conducted 2 days a week. Receives: Behavioral: Structured Exercise Group(YEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale(BBS)
The Berg Balance Scale consists of 14 functional tasks evaluating static and dynamic balance performance. Each task is scored on a 5-point scale (0 to 4), with total scores ranging from 0 to 56 (higher scores indicate superior balance control). The Minimal Detectable Change for clinical significance in individuals with stroke is established as 6 points.
Measured: Post-intervention and Post-treatment (Week 12)
Secondary outcomes (5)
Stroke Impact Scale(SIS)
The Stroke Impact Scale is a self- or caregiver-reported measure designed to assess health status and stroke-specific quality of life across 8 domains with a total of 59 items. Each item evaluates the level of difficulty experienced over the past week on a 5-point Likert scale. Domain scores range from 0 to 100, with higher scores indicating better quality of life and higher level of recovery. Additionally, the SIS includes a Visual Analog Scale (VAS) rating overall stroke recovery from 0 (no recovery) to 100 (full recovery).
Measured: Post-intervention and Post-treatment (Week 12)
Functional Independence Measure(FIM)
The Functional Independence Measure (FIM) evaluates functional autonomy across 18 items, divided into two primary subscales: Motor (13 items) and Cognitive (5 items). Each item is rated on a 7-point Likert scale ranging from 1 (total assistance / complete dependence - patient performs less than 25% of the task) to 7 (complete independence - patient performs the task safely and in a timely manner). The maximum achievable scores for the Motor and Cognitive subscales are 91 and 35, respectively. The total FIM score ranges from 18 to 126, with higher scores indicating greater functional independence.
Measured: Post-intervention and Post-treatment (Week 12)
Functional Reach Test(FRT)
The Functional Reach Test (FRT) assesses dynamic balance and stability limits. The participant stands sideways next to a wall with a measuring tape attached, with their preferred arm closer to the wall. The arm is extended forward to 90 degrees of shoulder flexion with the elbow straight and the hand in a fist. The initial position of the third metacarpal head is recorded. Maintaining the elbow, hand position, and horizontal alignment without taking a step or losing balance, the participant reaches forward as far as possible along the measuring tape. The difference between the baseline and maximum reach distance is recorded in centimeters (cm). The test is performed three times, and the best score (longest reach) is recorded, with higher values indicating better dynamic balance.
Measured: Post-intervention and Post-treatment (Week 12)
Fugl-Meyer Assessment of Lower Extremity(FMA-LE)
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) evaluates motor recovery stages and functional movement following stroke. This 17-item test assesses lower extremity motor function, including reflex activity, movement within and outside synergy patterns, and speed/coordination. It consists of two main components: Lower Extremity movement and Speed/Coordination. Each item is scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully). Total scores range from 0 to 34, with higher scores indicating better lower extremity motor function.
Measured: Post-intervention and Post-treatment (Week 12)
Timed Up And Go Test (TUG)
It is a test that measures mobility and balance in older adults. The TUG test was used in this study to assess mobility and balance. The score range for the TUG test can vary depending on the population tested and the criteria used for assessment; however, the general range is 10 to 20 seconds for older adults without mobility issues, and more than 20 seconds for those with mobility issues. The cutoff score indicating fall risk in elderly stroke patients is 14 seconds.
Measured: Post-intervention and Post-treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start27 Nov 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleyna Derin Ekinci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863271
- Sponsor's protocol ID
- E-10840098-202.3.02-8190
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with the informed consent form and institutional ethics committee regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Vibration Therapy Combined With a Structured Exercise Program on Functional Status in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07863271
- Acronym / sponsor ID
- E-10840098-202.3.02-8190
- Conditions
- Chronic Stroke
- Keywords
- stroke, local vibration, structured exercise, balance, motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if adding neck vibration to structured exercises improves balance and movement in adults with long-term stroke. The main questions it aims to answer are:
Does this exercise and vibration program improve balance, walking, and daily living skills?
Is structured exercise with neck vibration more effective than traditional exercise with neck vibration?
Researchers will compare a structured exercise group to a traditional exercise group to see if one works better.
Participants will:
Complete exercise sessions 2 days a week for 12 weeks
Receive 5 minutes of mild neck vibration after each exercise session
Take balance, walking, and daily activity tests at the start and end of the study
Detailed description
Stroke can lead to long-term difficulties with balance, walking, and everyday physical activities. This study evaluates and compares two different exercise programs, both combined with local cervical vibration, to support functional recovery in adults with chronic stroke.
Participants are randomly assigned to one of two groups:
Structured Exercise Group(YEG): Participants perform a specialized regimen that includes gaze stabilization, Cawthorne-Cooksey exercises, balance training, posture control, gait practice, and cervical and core strengthening.
Stroke can lead to long-term difficulties with balance, motor function, and everyday physical activities. This study evaluated and compared the effects of two different exercise programs (structured exercise versus traditional exercise), both combined with local cervical vibration, on balance, motor recovery, and functional performance in individuals with chronic stroke.
A total of 34 participants with chronic stroke (aged 40-80 years, with a stroke onset of at least 12 months) were randomly allocated into two equal groups:
Structured Exercise Group (n=17): Participants completed a comprehensive program consisting of gaze stabilization exercises, Cawthorne-Cooksey exercises, balance training, posture control, gait training, and cervical/core strengthening exercises.
Conventional Exercise Group (n=17)(GEG): Participants completed standard stroke rehabilitation exercises, including passive/active range of motion exercises, muscle stretching, strengthening, and gait training for both upper and lower extremities.
In both groups, 5 minutes of local vibration was applied to the cervical region immediately after each exercise session. Interventions were conducted 2 days per week for 12 weeks.
Participants were evaluated at baseline (pre-treatment) and at post-intervention (Week 12) using the following standardized outcome measures:
Fugl-Meyer Assessment of Lower Extremity(FMA-LE): Evaluates lower limb motor recovery.
Berg Balance Scale (BBS): Evaluates static and dynamic balance capacity.
Functional Reach Test (FRT): Measures margin of stability and forward reach limits.
Modified Ashworth Scale (MAS): It is used for the assessment of spasticity.
Timed Up and Go Test (TUG): It is used for measuring balance and mobility.
Functional Independence Measure (FIM) : Evaluates independence in daily living activities.
Stroke Impact Scale(SIS) : Measures health status and stroke-specific quality of life.
Barthel Index(BI): It is used for the assessment of activities of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Exercise Group(GEG) | Active comparator | Behavioral: Conventional Exercise Group(GEG)The Conventional Exercise Group(GEG) (n=17) received range of motion, stretching, strengthening, and gait exercises targeting the upper and lower extremities. Following the exercise sessions, this groups received 5 minutes of local vibration to the cervical region, and the treatment program was conducted 2 days a week. |
| Structured Exercise Group(YEG) | Experimental | Behavioral: Structured Exercise Group(YEG)The Structured Exercise Group(YEG) (n=17) received a program including gaze stabilization exercises, Cawthorne-Cooksey exercises, balance, posture, gait, and cervical/core exercises; Following the exercise sessions, this groups received 5 minutes of local vibration to the cervical region and the treatment program was conducted 2 days a week. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 80 years
- Diagnosis of ischemic stroke
- Post-stroke duration of at least 12 months (chronic stroke)
- Willingness to participate and provision of written informed consent
- Not currently participating in any ongoing physiotherapy or rehabilitation program
Key exclusion criteria (4 listed)
- Presence of any neurological, orthopedic, or sensory condition other than stroke that affects postural balance (e.g., vestibular neuritis, benign paroxysmal positional vertigo [BPPV], uncorrected visual impairments)
- History of more than two stroke events
- Severe spasticity defined as a Modified Ashworth Scale score of ≥ 3 in the affected extremities
- Severe functional dependence defined as a Barthel Index score of ≤ 61
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise Group(YEG)Also: YEGThe Structured Exercise Group (n=17) received gaze stabilization exercises, Cawthorne-Cooksey exercises, mat activities, gait training, balance board training, tandem walking, head rotations during dynamic walking, chin-tuck exercise, cervical isometric exercises, core stabilization exercise, and posture training in front of a mirror. Each exercise was performed for 1 set of 10 repetitions, except for balance board training, which was applied as 3 repetitions of 10 seconds. Following the completion of all exercises, a 5-minute local vibration application was administered to the cervical region. The treatment program was scheduled as 2 days per week. | Behavioural | Structured Exercise Group(YEG) |
| Conventional Exercise Group(GEG)Also: GEGThe Conventional Exercise Group (n=17) received range of motion exercises for the lower extremity, stretching exercises, gait training, and straight leg raise exercises. For the upper extremity, active/active-assisted/passive range of motion exercises, ball-squeezing exercise, multi-directional exercises with a bottle, reaching exercises, and weight-shifting exercises were administered. Each exercise was performed as 1 set of 10 repetitions. Following the completion of all exercises, a 5-minute local vibration application was administered to the cervical region. The treatment program was scheduled as 2 days per week. | Behavioural | Conventional Exercise Group(GEG) |
Primary outcome
Berg Balance Scale(BBS)
Time frame: Post-intervention and Post-treatment (Week 12)
The Berg Balance Scale consists of 14 functional tasks evaluating static and dynamic balance performance. Each task is scored on a 5-point scale (0 to 4), with total scores ranging from 0 to 56 (higher scores indicate superior balance control). The Minimal Detectable Change for clinical significance in individuals with stroke is established as 6 points.
5 secondary outcomes
Stroke Impact Scale(SIS)
Time frame: Post-intervention and Post-treatment (Week 12)
Functional Independence Measure(FIM)
Time frame: Post-intervention and Post-treatment (Week 12)
Functional Reach Test(FRT)
Time frame: Post-intervention and Post-treatment (Week 12)
Fugl-Meyer Assessment of Lower Extremity(FMA-LE)
Time frame: Post-intervention and Post-treatment (Week 12)
Timed Up And Go Test (TUG)
Time frame: Post-intervention and Post-treatment (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with the informed consent form and institutional ethics committee regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Group(YEG) and Conventional Exercise Group(GEG) in people with Chronic Stroke, run by Medipol University 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 4 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: finished, as of the sponsor's last update on 7 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Scale(BBS) (time frame: Post-intervention and Post-treatment (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.