StrokeNCT07551141
Effects of Plantar Vibration on Gait and Balance in Stroke
A study testing Plantar Vibration in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of local vibration applied to the plantar surface of the foot on gait speed and dynamic balance in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Plantar Vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2026to Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke occurred at least 6 months prior to enrollment.
- No cognitive or communication impairments that would interfere with participation.
- Ability to stand independently for 20 seconds or more.
- Ability to walk 10 meters independently, with or without walking aids or orthoses as needed.
- Age between 18 and 75 years.
- Lower extremity Brunnstrom stage of 4 or higher.
Who cannot join
- Presence of severe osteoarthritis in the lower extremities.
- Diagnosis of cancer or diabetic neuropathy.
- Presence of vestibular disorders.
- Lower extremity ulceration or amputation.
- History of vertigo.
- Alcohol consumption within the past 24 hours.
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- Hemodynamic instability.
- Stroke affecting the basilar artery or cerebellum (posterior circulation stroke).
- Presence of neurological disorders such as multiple sclerosis or Parkinson's disease.
- Acute lower extremity injury within the past 6 weeks.
- History of lower extremity surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu
Ahmet Burak MAVUŞ, MSc, 5388178351 ext. +90, a.burakmavus@gmail.com
About this study
Official title: Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Patients With Chronic Stroke: A Randomized Controlled Trial
This study aims to evaluate the effects of local vibration applied to the plantar surface of the foot on gait speed and dynamic balance in individuals with stroke.
Read the detailed description
The study, utilizing a randomized placebo controlled design, is planned to be conducted on a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive plantar vibration or placebo plantar vibration interventions.
- Conditions
- Stroke
- Being tested
- Plantar Vibration, Placebo Plantar Vibration
- Keywords
- Stroke, Plantar Vibration, Dynamic Balance, Gait Speed
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar VibrationOther
The patients in the study group will receive plantar vibration intervention with a frequency of 100 Hz on the affected plantar region for 30 minutes each day over 3 consecutive days.
Placebo Plantar VibrationOther
Participants in the placebo group will undergo the same procedure as the experimental group, including session duration and conventional rehabilitation, but the vibration device will not make contact with the plantar surface of the foot. The intervention will be delivered for 30 minutes per day over three consecutive days, with the device operating at 100 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Plantar Vibration Intervention Group | Experimental | In addition to the conventional rehabilitation program, participants in this group will receive plantar vibration applied to the affected plantar region at a frequency of 100 Hz. The vibration will be delivered for 30 minutes per day over three consecutive days, divided into three 10-minute application periods separated by 1-minute rests. Receives: Other: Plantar Vibration |
| Placebo Vibration Group | Placebo comparator | Participants in the placebo group will undergo the same procedure as the experimental group, including the session duration and conventional rehabilitation exercises, but the vibration device will not make contact with the plantar surface of the foot. The placebo plantar vibration will be applied for 30 minutes each day over 3 consecutive days. Participants are blinded to group allocation. Receives: Other: Placebo Plantar Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Gait speed will be assessed using the 10-Meter Walk Test. A 14-meter straight corridor will be used, with the 2nd and 12th meters marked. The stopwatch will start when the participant's foot crosses the 2-meter mark and stop when the foot crosses the 12-meter mark. No verbal encouragement or external motivation will be provided during the test. A change of 5.25 seconds in walking time or 0.05 m/s in walking speed after the intervention will be considered the minimal detectable change.
Measured: Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
Dynamic Balance
Dynamic balance will be assessed using the Timed Up and Go (TUG) test. Participants will be asked to stand up from a chair with arm support, walk 3 meters, turn around, walk back, and sit down. The time from standing up to sitting back down will be recorded with a stopwatch.
Measured: Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start24 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups: the experimental group receiving plantar vibration therapy and the control group receiving a placebo intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Tunçdemir, Bitlis Eren University
- Investigators
- Merve TUNÇDEMİR DURSUN, Asst. Prof., Principal investigator, Bitlis Eren UniversityAhmet Burak MAVUŞ, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551141
- Sponsor's protocol ID
- Beuftr_2
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Patients With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07551141
- Acronym / sponsor ID
- Beuftr_2
- Conditions
- Stroke
- Keywords
- Stroke, Plantar Vibration, Dynamic Balance, Gait Speed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Apr 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.
This study aims to evaluate the effects of local vibration applied to the plantar surface of the foot on gait speed and dynamic balance in individuals with stroke.
Detailed description
The study, utilizing a randomized placebo controlled design, is planned to be conducted on a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive plantar vibration or placebo plantar vibration interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: the experimental group receiving plantar vibration therapy and the control group receiving a placebo intervention.
| Arm | Type | Receives |
|---|---|---|
| Plantar Vibration Intervention Group | Experimental | Other: Plantar VibrationIn addition to the conventional rehabilitation program, participants in this group will receive plantar vibration applied to the affected plantar region at a frequency of 100 Hz. The vibration will be delivered for 30 minutes per day over three consecutive days, divided into three 10-minute application periods separated by 1-minute rests. |
| Placebo Vibration Group | Placebo comparator | Other: Placebo Plantar VibrationParticipants in the placebo group will undergo the same procedure as the experimental group, including the session duration and conventional rehabilitation exercises, but the vibration device will not make contact with the plantar surface of the foot. The placebo plantar vibration will be applied for 30 minutes each day over 3 consecutive days. Participants are blinded to group allocation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke occurred at least 6 months prior to enrollment.
- No cognitive or communication impairments that would interfere with participation.
- Ability to stand independently for 20 seconds or more.
- Ability to walk 10 meters independently, with or without walking aids or orthoses as needed.
- Age between 18 and 75 years.
Key exclusion criteria (11 listed)
- Presence of severe osteoarthritis in the lower extremities.
- Diagnosis of cancer or diabetic neuropathy.
- Presence of vestibular disorders.
- Lower extremity ulceration or amputation.
- History of vertigo.
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 |
|---|---|---|
| Plantar VibrationThe patients in the study group will receive plantar vibration intervention with a frequency of 100 Hz on the affected plantar region for 30 minutes each day over 3 consecutive days. | Other | Plantar Vibration Intervention Group |
| Placebo Plantar VibrationParticipants in the placebo group will undergo the same procedure as the experimental group, including session duration and conventional rehabilitation, but the vibration device will not make contact with the plantar surface of the foot. The intervention will be delivered for 30 minutes per day over three consecutive days, with the device operating at 100 Hz. | Other | Placebo Vibration Group |
Primary outcome
Gait Speed
Time frame: Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
Gait speed will be assessed using the 10-Meter Walk Test. A 14-meter straight corridor will be used, with the 2nd and 12th meters marked. The stopwatch will start when the participant's foot crosses the 2-meter mark and stop when the foot crosses the 12-meter mark. No verbal encouragement or external motivation will be provided during the test. A change of 5.25 seconds in walking time or 0.05 m/s in walking speed after the intervention will be considered the minimal detectable change.
Dynamic Balance
Time frame: Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
Dynamic balance will be assessed using the Timed Up and Go (TUG) test. Participants will be asked to stand up from a chair with arm support, walk 3 meters, turn around, walk back, and sit down. The time from standing up to sitting back down will be recorded with a stopwatch.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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.
Merve TUNÇDEMİR DURSUN, Asst. Prof. principal investigator
Bitlis Eren University
Ahmet Burak MAVUŞ, M.Sc. principal investigator
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantar Vibration in people with Stroke, run by Bitlis Eren 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 6 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: looking for participants now, as of the sponsor's last update on 2 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. Some participants in this study may receive a placebo. 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?
Contact Merve TUNÇDEMİR DURSUN, Asst. Prof. (5069452008 ext. +90, merve.kd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention). 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?
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 2 Oct 2026.