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CompletedNCT07863271Updated Oct 7, 2026

The Effect of Local Vibration Therapy Combined With a Structured Exercise Program on Functional Status in Individuals With Chronic Stroke

An interventional study of Structured Exercise Group(YEG) and Conventional Exercise Group(GEG) in Chronic Stroke, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2025, registered Sep 2026).
Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Stroke

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Keywords

  • stroke
  • local vibration
  • structured exercise
  • balance
  • motor function
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Medipol University is the lead sponsor of 320 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Conventional Exercise Group(GEG)

  • Experimental
    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.

    Behavioral: Structured Exercise Group(YEG)

Interventions

  • BehavioralStructured Exercise Group(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.

    Also known as: YEG

  • BehavioralConventional Exercise Group(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.

    Also known as: GEG

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Post-intervention and Post-treatment (Week 12)

Secondary outcomes

  1. 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).

    Time frame: Post-intervention and Post-treatment (Week 12)

  2. 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.

    Time frame: Post-intervention and Post-treatment (Week 12)

  3. 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.

    Time frame: Post-intervention and Post-treatment (Week 12)

  4. 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.

    Time frame: Post-intervention and Post-treatment (Week 12)

  5. 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.

    Time frame: Post-intervention and Post-treatment (Week 12)

07

Study locations

1 site
  • Yeni Huzur Medical Center
    Istanbul, Istanbul 34403, Turkey (Türkiye)
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Nov 27, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2025 to primary completion in Feb 2026, 3 months.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 3 months is below that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2026
First posted
Oct 7, 2026
StartActual
Nov 27, 2025
Primary completionActual
Feb 28, 2026
CompletionActual
Feb 28, 2026
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07863271
Lead sponsor
Medipol University
Responsible party
Aleyna Derin Ekinci (Physiotherapist, Medipol University) — Principal investigator
First posted
Oct 7, 2026
Start date
Nov 27, 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026
Last update
Oct 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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