Stroke
Conditions
Keywords
Stroke, Plantar Vibration, Dynamic Balance, Gait Speed
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 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
OTHERPlantar 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.
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.
Sponsors
Bitlis Eren University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: the experimental group receiving plantar vibration therapy and the control group receiving a placebo intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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. * History of lower extremity surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | 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 | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMerve TUNÇDEMİR DURSUN, Asst. Prof.
CONTACTAhmet Burak MAVUŞ, M.Sc.
PRINCIPAL_INVESTIGATORMerve TUNÇDEMİR DURSUN, Asst. Prof.
Bitlis Eren University
PRINCIPAL_INVESTIGATORAhmet Burak MAVUŞ, M.Sc.
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
Outcome results
None listed