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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plantar Vibration Intervention Group | Experimental | 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. |
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| Placebo Vibration Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merve TUNÇDEMİR DURSUN, Asst. Prof. | Contact | 5069452008 | +90 | merve.kd@hotmail.com |
| Ömer DURSUN, Assoc. Prof. | Contact | 5426088687 | +90 | fztomrdrsn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Merve TUNÇDEMİR DURSUN, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| Ömer DURSUN, Assoc. Prof. | Bitlis Eren University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Bolu | Merkez | 14280 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.
| 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. |
|
| Ahmet Burak MAVUŞ, M.Sc. |
| Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital |
| Principal Investigator |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |