Effects of Plantar Vibration on Gait Speed and Dynamic Balance in Patients With Chronic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Gait Speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Plantar Vibration (Other)
结局指标
主要结局
Gait Speed
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Merve Tunçdemir
Assistant Professor
Bitlis Eren University