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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.

Tracking Information
First Submitted Date  ICMJE September 20, 2017
First Posted Date  ICMJE October 23, 2017
Results First Submitted Date  ICMJE January 4, 2019
Results First Posted Date  ICMJE March 6, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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.
  • Feasibility - User Compliance in Wearing the Device [ Time Frame: Two 1-month durations ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
Safety - Occurrence of Adverse Events [ Time Frame: 1 month ]
Users will be evaluated to determine if there is an emergence of numbness after 1 month of using the device
Change History Complete list of historical versions of study NCT03318341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
Feasibility - User compliance in using the device [ Time Frame: 1 month ]
Users will be evaluated to determine if they are utilizing the device for at least 8 hours each day.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TheraBracelet Phase I
Official Title  ICMJE TheraBracelet Phase I Small Business Technology Transfer Research (STTR) - The 1st and Only Wearable to Instantly Improve Hand Function
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Hand Function
  • Stroke
  • Upper Extremity
  • Hemiparesis
  • Cerebrovascular Accident
  • Stroke Rehabilitation
Intervention  ICMJE
  • Device: Real Stimulation
    The device applies wrist vibration at a subthreshold (imperceptible) level.
  • Device: Sham Stimulation
    The device applies no vibration.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Real Stimulation
    • Device: Sham Stimulation
  • 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.
    Interventions:
    • Device: Real Stimulation
    • Device: Sham Stimulation
Publications * Seo NJ, Enders LR, Fortune A, Cain S, Vatinno AA, Schuster E, Ramakrishnan V, Feng W. Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Transl Stroke Res. 2019 Aug 23. doi: 10.1007/s12975-019-00724-9. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
24
Actual Study Completion Date  ICMJE November 28, 2018
Actual Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03318341
Other Study ID Numbers  ICMJE 1R41HD090792-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party TheraBracelet, Inc.
Study Sponsor  ICMJE TheraBracelet, Inc.
Collaborators  ICMJE Medical University of South Carolina
Investigators  ICMJE
Principal Investigator: Na Jin Seo, PhD Medical University of South Carolina
PRS Account TheraBracelet, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP