Vibrotactile Stimulation for Stroke Recovery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Marquette University
Must not be taking: Aminoglycosides, Curare-like agents
Disqualifiers: Bleeding disorder, Epilepsy, Schizophrenia, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain antibiotics or agents that affect neuromuscular function.
What data supports the effectiveness of the treatment Vibrotactile stimulation for stroke recovery?
Research shows that using mechanical vibration, similar to vibrotactile stimulation, can improve hand motor function in stroke survivors by enhancing sensory input. Additionally, motor rehabilitation programs that include tactile elements have been found to improve tactile sensation in individuals with chronic stroke, suggesting potential benefits for recovery.12345
Is vibrotactile stimulation safe for humans?
Research shows that using vibrotactile stimulation devices, like the TheraBracelet, is generally safe for stroke survivors, with only mild side effects such as worsened sensory scores in some cases. Most participants did not experience significant adverse effects, indicating that this type of stimulation is safe for prolonged use.678910
How is the treatment Vibrotactile Stimulation unique for stroke recovery?
Vibrotactile Stimulation (VTS) is unique because it uses mechanical vibrations to stimulate the affected limb, which can improve hand function and reduce muscle tightness in stroke survivors. Unlike traditional therapies, VTS can be delivered through a wearable device like the VTS Glove, making it suitable for both clinical and home use.147810
Eligibility Criteria
This trial is for stroke survivors with mild-to-moderate arm impairment, who can feel touch in the affected arm or thigh and have a minimal ability to extend their wrist. They must be at least 6 months post-stroke from an MCA event, able to consent and follow instructions, and have specific proprioceptive deficits. People with bleeding disorders, muscle diseases like ALS or myasthenia gravis, epilepsy, severe psychiatric conditions, pacemakers or significant heart issues cannot join.Inclusion Criteria
I had a stroke but can still stabilize and grip objects.
I can feel touch in my arm or thigh on the same side as my lesion.
I can slightly bend my wrist upwards.
See 4 more
Exclusion Criteria
You have a history of other mental health conditions like schizophrenia.
I am not currently using drugs that affect muscle function.
I have a tumor inside my brain.
See 9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Baseline Testing
Participants complete baseline tests of cognitive performance and sensorimotor impairment
3 days
3 visits (in-person)
Training
Participants undergo 20 sessions of training with supplemental kinesthetic feedback to improve motor control
20 days
20 visits (in-person)
Post-Training Assessment
Participants are re-tested on their capability to use a 3-DOF vibrotactile display for reach-to-grasp actions
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after training
4 weeks
Treatment Details
Interventions
- Vibrotactile stimulation (Behavioral Intervention)
Trial OverviewThe study tests if vibrotactile stimulation—a type of sensory feedback—can help improve arm function after stroke. Thirty participants will try this method while doing tasks like reaching out or simulating drinking from a glass to see if it enhances motor control.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Stroke Cohort - Whole Task TrainingExperimental Treatment1 Intervention
Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance
Group II: Stroke Cohort - Progressive TrainingExperimental Treatment1 Intervention
Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance
Vibrotactile stimulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Vibrotactile stimulation for:
- Rehabilitation of upper limb function in chronic stroke patients
- Relief of post-stroke spasticity
🇪🇺 Approved in European Union as Vibrotactile stimulation for:
- Rehabilitation of upper limb function in chronic stroke patients
- Improvement of tactile perception and voluntary movement
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Marquette UniversityMilwaukee, WI
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Who Is Running the Clinical Trial?
Marquette UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
Medical College of WisconsinCollaborator
References
Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. [2021]To investigate the effects of perturbation-based pinch task training on the sensorimotor performance of the upper extremities of patients with chronic stroke via a novel vibrotactile therapy system.
Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. [2022]Background. Up to 85% of people with chronic stroke experience somatosensory impairment, which contributes to poor sensorimotor control and non-use of the affected limb. Neurophysiological mechanisms suggest motor rehabilitation may improve tactile sense post-stroke, however, somatosensory recovery has rarely been reported in controlled trials. Objective. To compare the effect of four upper limb motor rehabilitation programs on the recovery of tactile sensation in adults with chronic stroke. Methods. Adults with chronic stroke and mild or moderate upper extremity hemiparesis (n = 167) were enrolled in a multi-site randomized controlled trial. Participants completed three weeks of gaming therapy, gaming therapy with additional telerehabilition, Constraint-Induced Movement therapy, or traditional rehabilitation. Here, we report the results of a secondary outcome, tactile sensation, measured with monofilaments, before and after treatment, and 6 months later. Results. A mixed-effects general linear model revealed similar positive change in tactile sensitivity regardless of the type of training. On average, participants were able to detect a stimulus that was 32% and 33% less after training and at 6-month follow-up, respectively. One-third of participants experienced recategorization of their level of somatosensory impairment (e.g., regained protective sensation) following training. Poorer tactile sensation at baseline was associated with greater change. Conclusions. About one-third of individuals with mild/moderate chronic hemiparesis experience sustained improvements in tactile sensation following motor rehabilitation, regardless of the extent of tactile input in the rehabilitation program. Potential for sensory improvement is an additional motivator for those post-stroke. Characteristics of those who improve and mechanisms of improvement are important future questions. Clinicaltrials.gov NCT02631850.
Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]Sensory impairment is associated with reduced functional recovery in stroke survivors. Invasive vagus nerve stimulation (VNS) paired with rehabilitative interventions improves motor recovery in chronic stroke. Noninvasive approaches, for example, transcutaneous auricular VNS (taVNS) are safe, well-tolerated and may also improve motor function in those with residual weakness. We report the impact of taVNS paired with a motor intervention, repetitive task practice, on sensory recovery in a cohort of patients with chronic stroke.
Effect of remote sensory noise on hand function post stroke. [2020]Hand motor impairment persists after stroke. Sensory inputs may facilitate recovery of motor function. This pilot study tested the effectiveness of tactile sensory noise in improving hand motor function in chronic stroke survivors with tactile sensory deficits, using a repeated measures design. Sensory noise in the form of subthreshold, white noise, mechanical vibration was applied to the wrist skin during motor tasks. Hand dexterity assessed by the Nine Hole Peg Test and the Box and Block Test and pinch strength significantly improved when the sensory noise was turned on compared with when it was turned off in chronic stroke survivors. The subthreshold sensory noise to the wrist appears to induce improvements in hand motor function possibly via neuronal connections in the sensoriomotor cortex. The approach of applying concomitant, unperceivable mechanical vibration to the wrist during hand motor tasks is easily adoptable for clinic use as well as unsupervised home use. This pilot study suggests a potential for a wristband-type assistive device to complement hand rehabilitation for stroke survivors with sensorimotor deficit.
Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. [2022]To explore the effects of Mobilization and Tactile Stimulation (MTS) and patterns of recovery in chronic stroke (>12mo) when upper limb (UL) "performance" has reached a clear plateau.
Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.
Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. [2021]Evaluate the feasibility and potential impacts on hand function using a wearable stimulation device (the VTS Glove) which provides mechanical, vibratory input to the affected limb of chronic stroke survivors.
Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. [2023]To test the feasibility and efficacy of the VibroTactile Stimulation (VTS) Glove, a wearable device that provides VTS to the impaired limb to reduce spastic hypertonia.
A wearable vibrotactile device for upper-limb bilateral motion training in stroke rehabilitation: A case study. [2020]Real-time feedback is essential for motor learning. Automated feedback is especially valuable for at-home stroke rehabilitation in the absence of therapist supervision. This study examined the effect of real-time corrective vibrotactile feedback for training bilateral reaching motions. A bilateral upper-limb motor learning system, comprising a wireless wearable sleeve-armband device for providing vibrotactile feedback, a computer target game, and a customized motion tracking technology, was developed and evaluated on both hemiparetic stroke survivors and able-bodied people. This paper introduces the system and presents preliminary data for one hemiparetic stroke subject and one healthy subject performing bimanual reaching motions in the transverse plane. Vibrotactile training was found to successfully alter both subjects' original trajectories and to improve the motion symmetry of the stroke subject. These preliminary findings indicated the potential efficacy of vibrotactile cues for unsupervised motor learning in both the healthy and the stroke populations.
Effect of vibration characteristics and vibror arrangement on the tactile perception of the upper arm in healthy subjects and upper limb amputees. [2021]Vibrotactile stimulation is a promising venue in the field of prosthetics to retrain sensory feedback deficits following amputation. Discrimination is well established at the forearm level but not at the upper arm level. Moreover, the effects of combining vibration characteristics such as duration and intensity has never been investigated.