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NCT Number: NCT07551141

Effects of Plantar Vibration on Gait and Balance in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet Burak MAVUŞ, MSc

CONTACT

[email protected]

5388178351 ext. +90

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plantar Vibration

Other

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 Vibration

Other

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 outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Burak MAVUŞ, M.Sc.

CONTACT

[email protected]

5388178351 ext. +90

Merve TUNÇDEMİR DURSUN, Asst. Prof.

CONTACT

[email protected]

5069452008 ext. +90

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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