Sensory Stimulation for Stroke Recovery

Overseen By Na Jin Seo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Spasticity medications

Disqualifiers: Severe spasticity, Orthopaedic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding gentle vibration to hand exercises, known as Concomitant Sensory Stimulation (or TheraBracelet), can help stroke survivors regain better hand function compared to exercises alone. Participants will be divided into two groups: one will receive the vibration, and the other will not. It is ideal for individuals who experienced a stroke over six months ago and face challenges with hand movements in daily activities.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.

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've changed spasticity medication or had a botulinum toxin injection in the last 3 months.

What prior data suggests that this sensory stimulation technique is safe for stroke recovery?

Research has shown that using vibration as part of sensory therapy is generally safe for stroke recovery. In one study with 25 participants, only 24% experienced mild side effects, indicating that the treatment likely does not worsen hand function. These findings suggest that this therapy is safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of concomitant sensory stimulation for stroke recovery because it introduces a novel method of using imperceptible vibrations to aid rehabilitation. Unlike traditional treatments like physical therapy or medication that focus on motor skills or blood thinning, this approach targets sensory pathways, potentially enhancing the brain's ability to rewire itself and improve function after a stroke. By stimulating the senses in a subtle way, the treatment hopes to accelerate recovery and improve outcomes in a manner that's both non-invasive and complementary to existing therapies.

What evidence suggests that combining vibration with hand task practice is effective for stroke recovery?

Research has shown that using vibration during therapy can improve hand movement in people who have had a stroke. In this trial, participants in the "Vibration" arm will receive imperceptible vibration as part of their treatment. Studies have found that combining vibration with regular hand exercises can lead to better recovery. For instance, one study showed that patients using both methods experienced significant improvements in hand function. Another study found that only a few participants had mild side effects, indicating that this treatment is generally safe. Overall, these findings suggest that adding vibration to therapy may enhance recovery for stroke survivors. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had a stroke at least 6 months ago and have difficulty with hand tasks. They must be able to follow instructions and not be on certain spasticity medications or undergoing other upper limb therapies. Severe spasticity, skin issues at the wrist, or other conditions affecting arm function disqualify them.

Inclusion Criteria

It has been over 6 months since my stroke.

I can complete hand tasks quickly, in less than 120 seconds.

Your average time to complete the Wolf Motor Function Test is more than 10 seconds.

Exclusion Criteria

I haven't changed my spasticity medication or had a botulinum toxin injection in my arm in the last 3 months.

I am currently receiving therapy for my arm.

I have a health condition that affects my arm's ability to move or feel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either imperceptible vibration or no vibration during hand task practice to enhance hand functional recovery

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concomitant Sensory Stimulation

Trial Overview The study is testing if adding vibration to regular hand exercises helps improve hand function better than just doing the exercises alone after a stroke. Participants will either receive real vibration stimulation or no stimulation while practicing hand tasks.

How Is the Trial Designed?

Group I: Vibration Active Control 1 Intervention

The device will deliver imperceptible vibration for the treatment group.

Group II: No Vibration Placebo Group 1 Intervention

The device will deliver no vibration for the control group.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A clinical trial is investigating the effectiveness of the TheraBracelet, a wrist-worn device that provides imperceptible vibration, in improving hand function for chronic stroke survivors during a 6-week hand task practice program.

The study aims to show that combining TheraBracelet stimulation with hand task practice is more effective than practice alone, potentially enhancing independence and quality of life for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Seo, NJ., Ramakrishnan, V., Woodbury, ML., et al.[2022]

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]

A systematic review of 8 studies on active sensory interventions for post-stroke upper limb recovery found that techniques like mirror therapy and motor imagery show promise, but strong evidence for their effectiveness in improving motor recovery is lacking.

The review highlights the need for a comprehensive active sensory protocol that combines cognitive, sensory, motor, and functional elements, and calls for high-quality randomized trials to better evaluate these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. Arya, KN., Pandian, S., Joshi, AK., et al.[2022]

Early sensory stimulation within the first 6 hours after an ischemic stroke may have significant effects on recovery, with preclinical studies showing both neuroprotective benefits and potential increases in infarct volumes by 30-50%.

Understanding the impact of acute sensory stimulation is crucial, as stroke patients often experience uncontrolled sensory inputs during transport and treatment, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory stimulation in acute stroke therapy. von Bornstädt, D., Gertz, K., Lagumersindez Denis, N., et al.[2023]

The TheraBracelet, a device providing low-level vibration, was found to be safe for chronic stroke survivors when worn for over 8 hours a day for 2 months, with fewer adverse events reported during the real stimulation month compared to the sham month.

Out of 25 participants, only 24% experienced mild adverse events, indicating that prolonged sensory stimulation does not significantly worsen hand function or sensation, suggesting it could be a beneficial tool for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Seo, NJ., Enders, LR., Fortune, A., et al.[2021]

In a pilot study involving 12 chronic stroke survivors, the use of the TheraBracelet, which provides subsensory vibratory stimulation, combined with self-directed therapy significantly improved hand function compared to a control group without vibration.

Participants who adhered to the therapy tasks showed greater improvements in hand function, indicating that both the use of the TheraBracelet and consistent practice of therapeutic tasks are important for recovery in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. Scronce, G., Ramakrishnan, V., Vatinno, AA., et al.[2023]

In a study involving 12 chronic stroke patients, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) combined with repetitive motor practice showed potential to improve sensory recovery, with 64% of participants regaining some sensation after treatment.

The results suggest that taVNS may enhance sensory recovery alongside motor rehabilitation, but further research with a larger group is needed to fully understand its effects on overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. Baig, SS., Falidas, K., Laud, PJ., et al.[2020]

In a pilot study with 12 stroke patients, the TheraBracelet showed significant improvements in grasping ability compared to reaching, suggesting it may be particularly beneficial for individuals with grasping deficits.

The study's findings indicate that TheraBracelet can enhance manual dexterity during task practice therapy, providing valuable insights for clinicians on how to effectively implement this treatment for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Using TheraBracelet on Grasping versus Reaching in Poststroke Rehabilitation. Pennington, A., Ramakrishnan, V., Scronce, G., et al.[2023]

Somatosensory deficits are very common after a stroke, affecting about 80% of survivors, and can significantly hinder their ability to interact with their environment, impacting their quality of life and safety.

While some recovery of sensory function can occur during rehabilitation without specific training, specialized sensory interventions have shown promise in improving both somatosensory and motor functions in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory syndromes. Klingner, CM., Witte, OW., Günther, A.[2012]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35382902/

Concomitant sensory stimulation during therapy to enhance ... Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8981199/

Concomitant sensory stimulation during therapy to enhance ... This research is expected to result in an efficacious therapeutic adjunct to enhance upper extremity rehabilitation outcomes for people with stroke.

3. archives-pmr.org archives-pmr.org/article/S0003-9993(17)30559-2/fulltext

TheraBracelet Sensory Stimulation To Enhance Hand ... To determine the efficacy of concomitant sensory stimulation during therapy on improving paretic hand function for chronic stroke survivors.

4. withpower.com withpower.com/trial/phase-stroke-10-2020-096c4

Sensory Stimulation for Stroke Recovery · Info for Participants Out of 25 participants, only 24% experienced mild adverse events, indicating that prolonged sensory stimulation does not significantly worsen hand function or ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/3682898

Effect of Self‐Directed Home Therapy Adherence ... This pilot study suggests that adherence to self-directed therapy at home combined with subsensory stimulation may affect recovery outcomes in stroke survivors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04569123

Study Details | NCT04569123 | Concomitant Sensory ... Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.

7. researchgate.net researchgate.net/publication/359746042_Concomitant_sensory_stimulation_during_therapy_to_enhance_hand_functional_recovery_post_stroke

(PDF) Concomitant sensory stimulation during therapy to ... Twelve chronic stroke survivors were randomly assigned to the treatment group receiving peripheral sensory stimulation or the control group receiving no ...