Effects of Plantar Vibration on Gait and Balance in Stroke

April 19, 2026 updated by: Merve Tunçdemir, Bitlis Eren University

Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Individuals With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study, utilizing a randomized placebo controlled design, is planned to be conducted on a minimum of 58 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 Type

Interventional

Enrollment (Estimated)

58

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 Contact

  • Name: Merve TUNÇDEMİR DURSUN, Asst. Prof.
  • Phone Number: +90 5069452008
  • Email: merve.kd@hotmail.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Bolu, Merkez, Turkey (Türkiye), 14280
        • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plantar Vibration Intervention Group
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.
Other: Plantar Vibration
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 Comparator: Placebo Vibration Group
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.
Other: Placebo Plantar Vibration
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
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.
Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: Merve TUNÇDEMİR DURSUN, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Ömer Dursun, Assoc. Prof., Bitlis Eren University
  • Principal Investigator: Ahmet Burak Mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beuftr_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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