Effects of Plantar Vibration on Gait and Balance in Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBitlis Eren University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of severe osteoarthritis in the lower extremities.
Diagnosis of cancer or diabetic neuropathy.
Presence of vestibular disorders.
Lower extremity ulceration or amputation.
Trial design
Design model
Parallel
Treatments tested in this trial
Plantar Vibration
Other interventionThe 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 interventionParticipants 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Plantar Vibration Intervention GroupExperimental treatment 1 intervention
Group B: Placebo Vibration GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the intervention2
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.
Time frame
Baseline (Day 1), immediately after the third intervention session (Day 3), and 1 week after the interventionSponsors and contacts
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Source ClinicalTrials.gov