Effect of Plantar Vibration in Stroke

April 15, 2025 updated by: Omer Dursun, Bitlis Eren University

Effect of Plantar Vibration on Ankle Proprioception in Stroke Patients

The aim of the study is to investigate the effect of plantar vibration on the ankle proprioception of patients with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14280
        • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

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:

  1. Two months or longer elapsed since the stroke,
  2. A Mini-Mental State Examination score of 24 or higher,
  3. Being between 45 and 75 years of age,
  4. Having a Brunnstrom stage of 4 or above,
  5. Ability to stand independently for 20 seconds or more,
  6. Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary.

Exclusion Criteria:

  1. The presence of severe osteoarthritis in the lower extremity,
  2. The presence of cancer or diabetic neuropathy,
  3. The presence of vestibular disorder,
  4. The presence of lower extremity ulceration or amputation,
  5. Hemodynamic instability,
  6. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  7. Having experienced an acute lower extremity injury in the last six weeks,
  8. History of lower extremity surgery,
  9. Alcohol consumption in the last 24 hours
  10. Posterior circulation stroke involving the basilar artery or cerebellum

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
Placebo Comparator: Placebo Vibration Group
In addition to the conventional treatment program, the placebo plantar vibration application will be applied to the plantar region of the patients in the placebo group. For the application, the local vibration device will be moved without touching the patient's skin while it is operational. The placebo plantar vibration will be applied for 30 minutes each day over 3 consecutive days.
Other: Placebo Plantar Vibration
The patients in the placebo group will receive placebo plantar vibration intervention with a frequency of 100 Hz on the affected plantar region, without touching the skin, for 30 minutes each day over 3 consecutive days.
Experimental: Local Vibration Intervention Group
In addition to the conventional treatment program, the patients in this group will receive plantar vibration application on the affected plantar region, utilizing a frequency of 100 Hz. The plantar vibration will be applied for 30 minutes each day over 3 consecutive days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Proprioception
Time Frame: Change from baseline ankle proprioception immediately and one week after the intervention
The effect of plantar vibration on ankle proprioception will be evaluated using the Cybex isokinetic dynamometer. The device will analyze the passive joint position sense of the ankle in various positions.
Change from baseline ankle proprioception immediately and one 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: ömer dursun, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Burak Mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 5, 2025

Primary Completion (Actual)

April 14, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-7

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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