Menu
Recruiting NCT07551141

Effects of Plantar Vibration on Gait and Balance in Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plantar Vibration, Placebo Plantar Vibration.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Patients With Chronic Stroke: A Randomized Controlled Trial

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Gait Speed [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi — Bolu

Identifiers

NCT: NCT07551141 · Beuftr_2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗