Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Individuals With Stroke: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bitlis Eren University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Gait Speed
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Placebo Plantar Vibration (Other)
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.
Intervention: Plantar Vibration (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Merve Tunçdemir
Assistant Professor
Bitlis Eren University