Effects of Plantar Vibration on Gait and Balance in Stroke
1 other identifier
interventional
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jul 2026
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
Study Completion
Last participant's last visit for all outcomes
September 1, 2026
April 24, 2026
April 1, 2026
2 months
April 19, 2026
April 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention
Study Arms (2)
Plantar Vibration Intervention Group
EXPERIMENTALIn 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 COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Merkez, 14280, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 19, 2026
First Posted
April 24, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04