TheraBracelet Phase I

• Sponsor: TheraBracelet, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03318341
• Collaborator: Medical University of South Carolina (Other)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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.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: Jan 9, 2018
• Actual Primary Completion Date: Oct 22, 2018
• Actual Study Completion Date: Nov 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Safety - Occurrence of Device-Related Adverse Events (AE) [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 [Two 1-month durations]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• TheraBracelet, Inc.
• Medical University of South Carolina

Investigators

• Principal Investigator: Na Jin Seo, PhD, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 2, 2018

More Information

Publications

None provided.

• Responsible Party: TheraBracelet, Inc.
• ClinicalTrials.gov Identifier: NCT03318341
• Other Study ID Numbers: 1R41HD090792-01A1
• First Posted: Oct 23, 2017
• Last Update Posted: May 7, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by TheraBracelet, Inc.: physical stimulation; Subliminal stimulation; stroke rehabilitation; upper extremity; paresis; patient safety
• Additional relevant MeSH terms: Stroke; Paresis

Study Results

Participant Flow

Arm/Group Title	Real Then Sham	Sham Then Real
Arm/Group Description	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 no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month. Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level. Sham Stimulation: The device applies no vibration.	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 no 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. Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level. Sham Stimulation: The device applies no vibration.
Period Title: Month 1
STARTED	13	13
COMPLETED	13	12
NOT COMPLETED	0	1
Period Title: Month 1
STARTED	13	12
COMPLETED	13	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Real Then Sham	Sham Then Real	Total
Arm/Group Description	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 no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month. Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level. Sham Stimulation: The device applies no vibration.	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 no 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. Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level. Sham Stimulation: The device applies no vibration.	Total of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (11)	58 (10)	60 (11)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	4 30.8%	8 30.8%
Male	9 69.2%	9 69.2%	18 69.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%	1 7.7%	2 7.7%
Not Hispanic or Latino	12 92.3%	12 92.3%	24 92.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 38.5%	6 46.2%	11 42.3%
White	7 53.8%	6 46.2%	13 50%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.7%	1 7.7%	2 7.7%
Region of Enrollment (participants) [Number]
United States	13 100%	13 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Safety - Occurrence of Device-Related Adverse Events (AE)
Description	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.
Time Frame	Two 1-month durations

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Real Then Sham	Sham Then Real
Arm/Group Description	Receive real stimulation for 1 month, then sham stimulation for 1 month.	Receive sham stimulation for 1 month, then real stimulation for 1 month.
Measure Participants	13	12
AE Month 1	2 15.4%	4 30.8%
AE Month 2	0 0%	1 7.7%

2. Primary Outcome

Title	Feasibility - User Compliance in Wearing the Device
Time Frame	Two 1-month durations

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Real Then Sham	Sham Then Real
Arm/Group Description	Receive real stimulation for 1 month, then sham stimulation for 1 month.	Receive sham stimulation for 1 month, then real stimulation for 1 month.
Measure Participants	13	12
Compliance Month 1	13 100%	12 92.3%
Compliance Month 2	13 100%	12 92.3%

Adverse Events

Time Frame	Adverse event data were collected for 2.5 month study period.
Arm/Group Title	Real Then Sham - Month 1 (Real)		Sham Then Real - Month 1 (Sham)		Real Then Sham - Month 2 (Sham)		Sham Then Real - Month 2 (Real)
Arm/Group Description	Receive real stimulation for month 1		Receive sham stimulation for month 1		Receive sham stimulation for month 2.		Receive real stimulation month 2.
All Cause Mortality
	Real Then Sham - Month 1 (Real)		Sham Then Real - Month 1 (Sham)		Real Then Sham - Month 2 (Sham)		Sham Then Real - Month 2 (Real)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)		0/13 (0%)		0/12 (0%)
Serious Adverse Events
	Real Then Sham - Month 1 (Real)		Sham Then Real - Month 1 (Sham)		Real Then Sham - Month 2 (Sham)		Sham Then Real - Month 2 (Real)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		2/12 (16.7%)		0/13 (0%)		0/12 (0%)
General disorders
Transient ischemic attack-like symptoms	0/13 (0%)	0	2/12 (16.7%)	2	0/13 (0%)	0	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Skin surgery	1/13 (7.7%)	1	0/12 (0%)	0	0/13 (0%)	0	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Real Then Sham - Month 1 (Real)		Sham Then Real - Month 1 (Sham)		Real Then Sham - Month 2 (Sham)		Sham Then Real - Month 2 (Real)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/13 (61.5%)		6/12 (50%)		6/13 (46.2%)		7/12 (58.3%)
General disorders
Temporary feeling of numbness or worsening in sensory scores	3/13 (23.1%)	6	3/12 (25%)	22	2/13 (15.4%)	3	5/12 (41.7%)	10
Temporary increase in Modified Ashworth scale scores	1/13 (7.7%)	1	0/12 (0%)	0	0/13 (0%)	0	0/12 (0%)	0
Temporary increase in pain	0/13 (0%)	0	2/12 (16.7%)	2	0/13 (0%)	0	1/12 (8.3%)	1
Temporary swelling	0/13 (0%)	0	0/12 (0%)	0	1/13 (7.7%)	1	3/12 (25%)	5
Other	2/13 (15.4%)	3	0/12 (0%)	0	2/13 (15.4%)	2	1/12 (8.3%)	2
Musculoskeletal and connective tissue disorders
Temporary reduction in grip strength	1/13 (7.7%)	1	0/12 (0%)	0	1/13 (7.7%)	1	1/12 (8.3%)	1
Skin and subcutaneous tissue disorders
Temporary skin irritation	3/13 (23.1%)	4	1/12 (8.3%)	3	2/13 (15.4%)	4	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.