Lower Limb Spasticity
Conditions
Keywords
mobility, lower limb, spasticity, walking endurance, home device, quality of life, vts, LLS, gait, stroke
Brief summary
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
Detailed description
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.
Interventions
DEVICEVibrotactile Stimulation (Static Use)
The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be worn during static conditions (e.g., standing or seated) and is intended for daily use at home or in-clinic.
DEVICEVibrotactile Stimulation (Dynamic Use)
The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used in dynamic conditions (e.g., walking) and is intended for daily use at home or in-clinic.
DEVICEVibrotactile Stimulation (Neurophysiological Mechanism)
The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used to investigate the neurophysiological mechanisms through which VTS modulates spasticity at different anatomical sites and its effectiveness on improving mobility. investigate the underlying neurophysiological mechanisms through which VTS modulates spasticity and muscle tone at different anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.
Sponsors
Weill Medical College of Cornell University
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Aim 1 is a within-subject, counterbalanced mechanistic study evaluating neurophysiological effects of VTS applied to three anatomical sites. Aim 2 is a randomized crossover trial comparing the effects of VTS during (a) static positioning and (b) dynamic gait training, each applied over 3 consecutive daily sessions with a one-week washout period between conditions. This study includes a randomized, two-period crossover design in Aim 2, in which each participant will undergo two VTS conditions: (1) static use (resting position) and (2) dynamic use (during gait training). The order of these two intervention phases will be randomized to minimize order effects and participant-specific bias. Participants will be randomized in a 1:1 ratio to one of two sequences: Sequence A: Static VTS → Washout → Gait VTS Sequence B: Gait VTS → Washout → Static VTS
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ≥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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H-reflex amplitude Baseline (Aim 1) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go (TUG) at Baseline (Aim 2) | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 | Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better. |
| Timed up and go (TUG) After Intervention (Aim 2) | Immediately after intervention for 3 consecutive days for Aim 2 | Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better. |
| Two minute walk test (TMWT) at Baseline (Aim 2) | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 | Assesses functional mobility, balance, and fall risk. Time (s); lower is better. |
| Two minute walk test (TMWT) After Intervention (Aim 2) | Immediately after intervention for 3 consecutive days for Aim 2 | Assesses functional mobility, balance, and fall risk. Time (s); lower is better. |
| Berg Balance Scale (BBS) at Baseline (Aim 2) | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 | Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance. |
| Berg Balance Scale (BBS) After Intervention (Aim 2) | Immediately after intervention for 3 consecutive days for Aim 2 | Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance. |
| Global Impression of Change Scale (GICS) at Baseline (Aim 2) | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 | Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved. |
| Global Impression of Change Scale (GICS) After Intervention (Aim 2) | Immediately after intervention for 3 consecutive days for Aim 2 | Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved. |
| Short form 12 (SF12) at Baseline (Aim 2) | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 | Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better |
| Short form 12 (SF12) After Intervention (Aim 2) | Immediately after intervention for 3 consecutive days for Aim 2 | Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoan Stilling, M.D., M.S.
Weill Medical College of Cornell University
Outcome results
None listed