Vibrotactile Stimulation for Lower Limb Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- H-reflex amplitude Baseline (Aim 1)
研究概览
简要总结
The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are:
- Which areas of the body are the best for applying VTS?
- Does VTS help improve walking speed in people with lower limb spasticity?
Participants will:
- Receive 15 minutes of VTS treatment on different parts of the body
- Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking)
- Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience
- Complete assessments after the treatment to measure change in mobility
- Complete surveys about how comfortable the device is to use
详细描述
This study will investigate both the neurophysiological mechanisms and clinical effects of VTS in individuals with poststroke lower limb spasticity.
Aim 1 will assess how different anatomical placements of VTS impact neuromuscular activity and spasticity.
Aim 2 will test the feasibility and efficacy of VTS during both static and dynamic gait contexts using a randomized crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Given the nature of the intervention (wearable vibrotactile stimulation), full participant blinding is not feasible. However, bias will be minimized through the following:
Outcome assessments (e.g., 10MWT, MAS, TUG) will be performed by blinded raters who are not involved in administering the intervention and will remain unaware of the VTS condition.
Participants will be instructed not to disclose their condition to outcome assessors. Statistical analysis will be conducted by team members who are blinded to the intervention sequence.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥6 months following neurologic diagnosis leading to spasticity
- •Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.
- •Ability to stand (with or without assistance) and lie supine.
- •Able to understand and comply with study procedures.
排除标准
- •Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.
- •Previous surgery to treat spasticity in the affected lower limb.
- •Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.
- •Unstable medication regimens for spasmolysis or muscle relaxation.
- •Participation in tone-related treatments (e.g., physiotherapy, TENS, acupuncture) within 4 weeks prior to baseline. If ongoing treatment started more than 4 weeks before baseline, it should remain consistent throughout the study
研究组 & 干预措施
VTS Static Use, then Dynamic Use (Aim 2)
The participant will first use the VTS device for 60 minutes daily for three consecutive days while in a static position. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days during active gait training.
干预措施: Vibrotactile Stimulation (Static Use) (Device)
VTS Neurophysiological Mechanism (Aim 1)
The participant will use the VTS device for three 15-minutes sessions, once for each anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.
干预措施: Vibrotactile Stimulation (Neurophysiological Mechanism) (Device)
VTS Dynamic Use, then Static Use (Aim 2)
The participant will first use the VTS device for 60 minutes daily for three consecutive days during active gait training. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days while in a static position.
干预措施: Vibrotactile Stimulation (Dynamic Use) (Device)
结局指标
主要结局
H-reflex amplitude Baseline (Aim 1)
时间窗: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
H-reflex amplitude After Intervention (Aim 1)
时间窗: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
Surface EMG activity of gastrocnemius/soleus Baseline (Aim 1)
时间窗: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
Surface EMG activity of gastrocnemius/soleus After Intervention (Aim 1)
时间窗: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
Modified Ashworth Scale at Screening
时间窗: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Modified Ashworth Scale at Baseline (Aim 1)
时间窗: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Modified Ashworth Scale After Intervention (Aim 1)
时间窗: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Modified Ashworth Scale at Baseline (Aim 2)
时间窗: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Modified Ashworth Scale After Intervention (Aim 2)
时间窗: Immediately after intervention for 3 consecutive days for Aim 2
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Passive range of motion at the ankle at Screening
时间窗: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Passive range of motion at the ankle at Baseline (Aim 1)
时间窗: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Passive range of motion at the ankle After Intervention (Aim 1)
时间窗: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Passive range of motion at the ankle at Baseline (Aim 2)
时间窗: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Passive range of motion at the ankle After Intervention (Aim 2)
时间窗: Immediately after intervention for 3 consecutive days for Aim 2
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
10 meter walk test at Baseline (Aim 2)
时间窗: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
10 meter walk test at Baseline After Intervention (Aim 2)
时间窗: Immediately after intervention for 3 consecutive days for Aim 2
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
次要结局
- Timed up and go (TUG) at Baseline (Aim 2)(Baseline measurement immediately before intervention for 3 consecutive days for Aim 2)
- Timed up and go (TUG) After Intervention (Aim 2)(Immediately after intervention for 3 consecutive days for Aim 2)
- Two minute walk test (TMWT) at Baseline (Aim 2)(Baseline measurement immediately before intervention for 3 consecutive days for Aim 2)
- Two minute walk test (TMWT) After Intervention (Aim 2)(Immediately after intervention for 3 consecutive days for Aim 2)
- Berg Balance Scale (BBS) at Baseline (Aim 2)(Baseline measurement immediately before intervention for 3 consecutive days for Aim 2)
- Berg Balance Scale (BBS) After Intervention (Aim 2)(Immediately after intervention for 3 consecutive days for Aim 2)
- Global Impression of Change Scale (GICS) at Baseline (Aim 2)(Baseline measurement immediately before intervention for 3 consecutive days for Aim 2)
- Global Impression of Change Scale (GICS) After Intervention (Aim 2)(Immediately after intervention for 3 consecutive days for Aim 2)
- Short form 12 (SF12) at Baseline (Aim 2)(Baseline measurement immediately before intervention for 3 consecutive days for Aim 2)
- Short form 12 (SF12) After Intervention (Aim 2)(Immediately after intervention for 3 consecutive days for Aim 2)