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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are: Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function? Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.

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 data supports the idea that Vibrotactile Stimulation for Stroke Rehabilitation is an effective treatment?

The available research shows that Vibrotactile Stimulation (VTS) can be an effective treatment for stroke rehabilitation. One study found that daily VTS provided equal or greater relief from muscle stiffness compared to a common treatment using botulinum toxin. Another study using a wearable VTS glove showed potential improvements in hand function for stroke survivors. These findings suggest that VTS can help improve movement and reduce muscle tightness in people recovering from a stroke. ^{1 2 3 4 5}

What safety data exists for vibrotactile stimulation in stroke rehabilitation?

The available research on vibrotactile stimulation for stroke rehabilitation suggests it is a promising method for improving motor function. The studies reviewed do not specifically report adverse events related to vibrotactile stimulation, indicating it may be a safe option. However, detailed safety data is limited, and more comprehensive studies are needed to fully understand the safety profile of this treatment. ^{2 5 6 7 8}

Is Vibrotactile Stimulation a promising treatment for stroke rehabilitation?

Yes, Vibrotactile Stimulation is a promising treatment for stroke rehabilitation. It can provide equal or greater relief from muscle stiffness compared to some drugs, and it helps improve hand function in stroke survivors. ^{1 2 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a VibroTactile Feedback System in Stroke Subjects. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A wearable vibrotactile device for upper-limb bilateral motion training in stroke rehabilitation: A case study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. [2023]

9. England 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging of the human sensorimotor cortex using a novel vibrotactile stimulator. [2019]