Vibrotactile Stimulation for Stroke Rehabilitation

Recruiting at 1 trial location

Overseen By Mazen Al Borno, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Must not be taking: Anti-spasticity therapy

Disqualifiers: Pacemakers, Defibrillators, Lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special wearable gear, such as gloves and shirts, can enhance arm use in stroke patients. The wearables provide vibrotactile stimulation, a gentle vibration that may improve arm function when combined with regular therapy. Participants will either use these wearables or continue with their usual therapy. Individuals who experienced a stroke in the past two weeks and have some shoulder and elbow movement might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are under anti-spasticity therapy, you cannot participate in the trial.

What prior data suggests that this vibrotactile stimulation is safe for stroke rehabilitation?

Research shows that vibrotactile stimulation, similar to that used in this trial, has been tested in other studies and appears safe. For instance, studies have found that vibrotactile stimulation gloves can significantly reduce symptoms like muscle tightness and stiffness in stroke patients without major side effects. These gloves have been used daily in similar treatments, and most people have tolerated them well.

Since this trial is in an early stage, the main goal is to ensure the treatment's safety for participants. Researchers closely monitor for any side effects or discomfort. So far, individuals using similar devices in past studies have not reported serious problems, suggesting the treatment is likely safe. However, as with any medical trial, participants will be monitored to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vibrotactile stimulation for stroke rehabilitation because it introduces a new approach to therapy by using wearable technology. Unlike traditional rehabilitation methods, which typically involve physical exercises and occupational therapy, this treatment uses shirts and gloves that deliver vibrations to stimulate the body. This method has the potential to enhance recovery by providing continuous sensory feedback, possibly accelerating the rehabilitation process. Additionally, the convenience of wearing these devices after conventional therapy sessions could make it easier to integrate into daily routines, maximizing therapy benefits without additional effort.

What evidence suggests that vibrotactile stimulation is effective for stroke rehabilitation?

Research has shown that vibrotactile stimulation, like the one used in this trial, can help stroke patients improve arm movement. Participants in this trial will wear vibrotactile stimulation shirts and gloves. Studies have found that using a vibrotactile glove can reduce muscle stiffness and tension in stroke survivors. These improvements are often as good as or better than those seen with Botox injections. Early findings also suggest that this type of stimulation can effectively reduce muscle tightness, which is common after a stroke. Overall, vibrotactile stimulation appears promising in helping stroke patients regain arm movement. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for stroke patients who are currently inpatients at rehabilitation units, had a stroke on one side of the body within the last 2 weeks, and have some arm movement. They should be able to stay for 2-3 weeks in rehab and participate in additional therapy with special gloves and shirts that provide gentle vibrations.

Inclusion Criteria

My arm movement score is between 6 and 58.

I can lift my arm and bend my elbow.

Expected to stay 1-3 weeks in the rehabilitation unit

Exclusion Criteria

Patients that are dependent on pacemakers

Patients that have defibrillators

I have swelling in my arm or a special connection for dialysis on an arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy

2-3 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Stimulation

Trial Overview

The study is testing if wearing gloves and shirts that give off gentle vibrations (vibrotactile stimulation) can help improve arm function after a stroke. Patients will use these wearables for five hours daily along with their regular therapy, while their progress is compared to those receiving only conventional therapy.

How Is the Trial Designed?

Group I: Vibrotactile Stimulation Experimental Treatment 1 Intervention

Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day.

Group II: Control Active Control 1 Intervention

Participants undergo conventional therapy only.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

The study involved 19 patients with chronic stroke and demonstrated that perturbation-based pinch task training significantly improved sensory function in the affected thumb, as measured by the Semmes-Weinstein monofilament test, immediately after training.

At the 12-week follow-up, the experimental group also showed significant improvements in the box and block test, indicating enhanced motor performance, while the control group had notable improvements in wrist and coordination scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Hsu, HY., Kuan, TS., Tsai, CL., et al.[2021]

The VibroTactile Stimulation (VTS) Glove significantly reduced spastic hypertonia in patients with chronic stroke, showing clinically meaningful improvements in spasticity scores after 8 weeks of use and even 4 weeks after stopping the intervention.

For patients who were also receiving Botulinum toxin (BTX-A), over half experienced greater symptom relief with the VTS Glove compared to their previous BTX-A treatment, indicating that the VTS Glove could be an effective alternative or complement to traditional spasticity treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. Seim, C., Chen, B., Han, C., et al.[2023]

The study developed a wireless wearable device that provides real-time vibrotactile feedback to assist in motor learning for bilateral reaching motions, which is particularly useful for at-home rehabilitation after a stroke.

Preliminary results from one hemiparetic stroke survivor and one healthy subject showed that vibrotactile feedback effectively improved motion symmetry and altered reaching trajectories, suggesting its potential for enhancing motor learning in both populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable vibrotactile device for upper-limb bilateral motion training in stroke rehabilitation: A case study. Hung, CT., Croft, EA., Van der Loos, HF.[2020]

A systematic review of 75 studies on noninvasive electrical stimulation (ES) in stroke recovery found that adverse events were mostly minor, with tingling being the most common at 18.1% prevalence among participants.

While some adverse events like itching and discomfort were associated with specific stimulation parameters, the overall safety profile of ES appears favorable, with only two severe adverse events reported, indicating it can be a safe therapeutic option for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. Turnbull, C., Boomsma, A., Milte, R., et al.[2023]

Mobilization and Tactile Stimulation (MTS) can lead to improvements in upper limb motor function and impairment in chronic stroke survivors, even more than a year after their stroke, as shown in a study with 8 participants.

While all participants showed improvements in motor impairment, clinically significant enhancements in motor function were observed in half of the participants, with recovery often taking several days to manifest after starting the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. Winter, JM., Crome, P., Sim, J., et al.[2022]

The Arm Usage Coach (AUC) system, which provides VibroTactile (VT) feedback to encourage arm movement in stroke patients, was found to be a feasible and accepted method for enhancing upper extremity use during daily activities.

Initially, most participants preferred acoustic or visual feedback, but after using the AUC, nine out of ten participants favored VT feedback, indicating its effectiveness in motivating arm use in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a VibroTactile Feedback System in Stroke Subjects. Held, JP., Klaassen, B., van Beijnum, BF., et al.[2022]

Vibrotactile stimulation can effectively enhance spatial discrimination and tactile intensity perception in both healthy individuals and amputees, with circular arrangements of vibrators yielding better results than linear ones.

The study found that the intensity and duration of vibrations significantly affect perception, with amputees achieving up to 91.67% accuracy using the optimal circular proportional arrangement, suggesting strong potential for improving sensory feedback in prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vibration characteristics and vibror arrangement on the tactile perception of the upper arm in healthy subjects and upper limb amputees. Guemann, M., Bouvier, S., Halgand, C., et al.[2021]

The study used fMRI to show that a novel vibrotactile stimulator effectively activates the sensorimotor cortex in healthy subjects during vibration of the palm, indicating its potential for assessing sensory and motor functions.

The new device allows for controlled vibration frequencies and amplitudes, making it a promising alternative for evaluating patients who cannot perform active motor tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging of the human sensorimotor cortex using a novel vibrotactile stimulator. Golaszewski, SM., Siedentopf, CM., Baldauf, E., et al.[2019]

The TheraBracelet, which provides imperceptible vibratory stimulation to the wrist, was found to be feasible and safe for use during hand therapy in stroke survivors, with no adverse events reported.

In a pilot study with 12 chronic stroke survivors, those using TheraBracelet showed significant improvements in motor function (measured by the Box and Block Test) compared to a control group, suggesting it may enhance recovery outcomes when used alongside traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Seo, NJ., Woodbury, ML., Bonilha, L., et al.[2023]

In a study involving 16 chronic stroke survivors, the VTS Glove, which provides vibrotactile stimulation, significantly improved tactile perception and reduced spasticity in the affected hand over an 8-week period.

Participants using the VTS Glove also experienced increased voluntary finger flexion and improved range of motion in the elbow and shoulder, suggesting that wearable stimulation devices can enhance hand function in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. Seim, CE., Wolf, SL., Starner, TE.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7824932/

Wearable vibrotactile stimulation for upper extremity ...

Upper limb disability occurs in about 50% of cases [4, 5] and diminished tactile perception in about 35-55% [6, 7]. Current methods of therapy ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999323002381

Daily Vibrotactile Stimulation Exhibits Equal or Greater ...

The VTS Glove, which delivers mobile or home-based upper extremity VTS in stroke survivors, provides reduction of spasticity and hypertonia equal to or ...

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frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1206027/full

Relief of post-stroke spasticity with acute vibrotactile ...

Cutaneous vibrotactile stimulation of the hand provides significant reductions in spastic hypertonia, compared to muscle stimulation.

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archives-pmr.org

archives-pmr.org/article/S0003-9993(23)00238-1/abstract

Daily Vibrotactile Stimulation Exhibits Equal or Greater ...

The VTS Glove was associated with greater average improvement in spasticity and hypertonia than Botox injection.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11326884/

Daily vibrotactile stimulation from a wearable device exhibits ...

The purpose of this study was to assess the efficacy of the VTS Glove for home-based therapy in stroke patients with upper limb spastic ...