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?

The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

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.

Is the TheraBracelet safe for use in humans?

The TheraBracelet, a wrist-worn device providing low-level vibration, was tested in stroke survivors and found to be generally safe for daily use over a month. Some mild adverse events, like worsened sensory scores, were reported, but they were not consistently linked to the device. ^{1 2 3 4 5}

How is the TheraBracelet treatment different from other stroke recovery treatments?

The TheraBracelet treatment is unique because it uses a wrist-worn device to provide imperceptible vibratory stimulation during hand tasks, allowing for continuous sensory stimulation without interfering with natural movements. This approach contrasts with other methods that require separate time commitments and may disrupt hand activities. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Concomitant Sensory Stimulation, TheraBracelet, Concomitant Sensory Stimulation for stroke recovery?

Research suggests that sensory stimulation, like that provided by TheraBracelet, can be safe and may help improve recovery in stroke survivors by enhancing motor and sensory functions. Although more studies are needed, similar treatments have shown potential benefits in improving outcomes for stroke patients. ^{2 6 7 8 9}

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 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]

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]

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]

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]

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]

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 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]

Citations

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

Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. [2022]

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

Sensory stimulation in acute stroke therapy. [2023]

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

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]

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

Sensory syndromes. [2012]

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

Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. [2022]

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

Effect of Using TheraBracelet on Grasping versus Reaching in Poststroke Rehabilitation. [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. United States pubmed.ncbi.nlm.nih.gov

Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. [2023]