61 Participants Needed

Sensory Stimulation for Stroke Recovery

NJ
Overseen ByNa Jin Seo, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.36789

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.23568

Eligibility Criteria

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.
I am 18 years old or older.
See 1 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Concomitant Sensory Stimulation
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: VibrationActive Control1 Intervention
The device will deliver imperceptible vibration for the treatment group.
Group II: No VibrationPlacebo Group1 Intervention
The device will deliver no vibration for the control group.

Find a Clinic Near You

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+

Findings from Research

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.
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.
Sensory stimulation in acute stroke therapy.von Bornstรคdt, 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.
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]

References

Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. [2022]
Sensory stimulation in acute stroke therapy. [2023]
Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]
Sensory syndromes. [2012]
Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]
Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. [2022]
Effect of Using TheraBracelet on Grasping versus Reaching in Poststroke Rehabilitation. [2023]
TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. [2023]
Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. [2023]