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TheraBracelet Phase I

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ClinicalTrials.gov Identifier: NCT03318341
Recruitment Status : Completed
First Posted : October 23, 2017
Results First Posted : March 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
TheraBracelet, Inc.

Brief Summary:
This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.

Condition or disease Intervention/treatment Phase
Hand Function Stroke Upper Extremity Hemiparesis Cerebrovascular Accident Stroke Rehabilitation Device: Real Stimulation Device: Sham Stimulation Not Applicable

Detailed Description:
Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. Existing devices such as hand-opening orthoses are expensive, uncomfortable, bulky, and meant for use during short therapy sessions as opposed to during daily living. Thus their impact is limited. Consequently, the development of efficacious and affordable assistive device is of importance. This project addresses this critical gap by providing an innovative patent-pending technology. The "TheraBracelet" is a wristband applying imperceptible vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors' touch sensation and hand dexterity in previous studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. The essential next step, thus the objective of this Phase I project, is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the real vibration condition compared to the sham vibration condition (wearing the device without vibration). The feasibility and safety level comparable to those of wearing a watch and of a comparable FDA-approved device will support viability of TheraBracelet with necessary regulatory approvals. This project is expected to lead to an assistive wristband that increases hand function during activities of daily living for a large number of stroke survivors with hand impairment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will use a 2×2 crossover design. Participants will be randomly assigned to either the treatment or control condition for the first month, followed by a 2-week washout period and then crossover to the other condition.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants will be blinded to the conditions, since they will not perceive any vibration for both conditions. The researcher conducting the evaluations with participants will also be blinded with the following procedure: A person outside the university will generate a random condition assignment sequence and send a custom program to the researcher to use.
Primary Purpose: Treatment
Official Title: TheraBracelet Phase I Small Business Technology Transfer Research (STTR) - The 1st and Only Wearable to Instantly Improve Hand Function
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : November 28, 2018

Arm Intervention/treatment
Real then Sham
Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies sham stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.
Device: Real Stimulation
The device applies wrist vibration at a subthreshold (imperceptible) level.

Device: Sham Stimulation
The device applies no vibration.

Sham then Real
Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies sham stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.
Device: Real Stimulation
The device applies wrist vibration at a subthreshold (imperceptible) level.

Device: Sham Stimulation
The device applies no vibration.




Primary Outcome Measures :
  1. Safety - Occurrence of Device-Related Adverse Events (AE) [ Time Frame: Two 1-month durations ]
    Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.

  2. Feasibility - User Compliance in Wearing the Device [ Time Frame: Two 1-month durations ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years or older
  • Time since stroke: > 3 months
  • Those with at least some movement in the affected upper limb
  • Ability to put on the device at home
  • Ability to perform the Box and Block Test with a score > 0

Exclusion Criteria:

  • Comorbidity such as neuropathy, orthopaedic conditions in the hand
  • Compromised skin integrity of the hand/wrist.
  • Participation in an upper limb rehabilitation program concurrently
  • Pregnancy
  • A language barrier or cognitive impairment that precludes following
  • Individuals whose swelling changes dramatically during the day
  • Participant has received Botulinum toxin injection in the past 3 months
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318341


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
TheraBracelet, Inc.
Medical University of South Carolina
Investigators
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Principal Investigator: Na Jin Seo, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by TheraBracelet, Inc.:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TheraBracelet, Inc.
ClinicalTrials.gov Identifier: NCT03318341     History of Changes
Other Study ID Numbers: 1R41HD090792-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2017    Key Record Dates
Results First Posted: March 6, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request.
Time Frame: The data will become available within 1 year from the study completion date for 6 years.
Access Criteria: De-identified data only

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by TheraBracelet, Inc.:
physical stimulation
Subliminal stimulation
stroke rehabilitation
upper extremity
paresis
patient safety
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms