An interventional study of Conventional Physiotherapy and Plantar Vibration in Stroke, sponsored by Bitlis Eren University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment
The aim of this study is to investigate the effects of a custom-made vibration insole on gait, balance, and fall risk in patients with stroke.
The study, utilizing a randomized controlled design, is planned to be conducted in a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Participants will be randomly assigned to either the intervention group, receiving a custom-made vibration insole in addition to conventional physiotherapy, or the control group, receiving conventional physiotherapy alone.
7,448 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 34 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Bitlis Eren University is the lead sponsor of 50 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation.
Other: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation, in addition to plantar vibration delivered using the custom-made vibration insole for 30 minutes per day over three consecutive days.
Other: Conventional Physiotherapy · Other: Plantar Vibration
Participants in this group will receive conventional physiotherapy every weekday throughout the study period, including therapeutic exercises and functional electrical stimulation aimed at improving lower-extremity muscle strength and gait.
Participants in this group will receive plantar vibration using a custom-made vibration insole for 30 minutes per day over three consecutive days, in addition to conventional physiotherapy throughout the study period.
Overall Postural Stability Index Measurement
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Time frame: Change from baseline overall postural stability index immediately and one week after the intervention
Fall Risk Assessment
Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with three 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.
Time frame: Change from baseline fall risk immediately and one week after the intervention
Anteroposterior Stability Index Measurement
The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction. Lower scores indicate smaller deviations and better anteroposterior postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Time frame: Change from baseline anteroposterior stability index immediately and one week after the intervention
Mediolateral Stability Index Measurement
The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction. Lower scores indicate smaller deviations and better mediolateral postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Time frame: Change from baseline mediolateral stability index immediately and one week after the intervention
Timed Up and Go Test
The Timed Up and Go test will be used to assess dynamic balance and functional mobility. Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. The time required to complete the task will be recorded in seconds. Shorter completion times indicate better functional mobility and dynamic balance.
Time frame: Change from baseline Timed Up and Go test performance immediately and one week after the intervention
10-Meter Walk Test
Walking speed will be assessed using the 10-Meter Walk Test. Participants will be instructed to walk a 10-meter distance at their usual walking speed, and the time required to complete the test will be recorded. Walking speed will be calculated in meters per second (m/s), with higher speeds indicating better walking performance.
Time frame: Change from baseline walking speed immediately and one week after the intervention
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bitlis Eren University