Hand Function, Stroke, Upper Extremity, Hemiparesis, Cerebrovascular Accident, Stroke Rehabilitation
Conditions
Keywords
physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, patient safety
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.
Interventions
DEVICEReal Stimulation
The device applies wrist vibration at a subthreshold (imperceptible) level.
DEVICESham Stimulation
The device applies no vibration.
Sponsors
Medical University of South Carolina
TheraBracelet, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Feasibility - User Compliance in Wearing the Device | Two 1-month durations | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 13 |
| 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 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. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Real Then Sham | Total | Sham Then Real |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 13 Participants | 6 Participants |
| Region of Enrollment United States | 13 participants | 26 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 8 / 13 | 6 / 12 | 6 / 13 | 7 / 12 |
| serious Total, serious adverse events | 1 / 13 | 2 / 12 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Feasibility - User Compliance in Wearing the Device
Time frame: Two 1-month durations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Real Then Sham | Feasibility - User Compliance in Wearing the Device | Compliance Month 1 | 13 Participants |
| Real Then Sham | Feasibility - User Compliance in Wearing the Device | Compliance Month 2 | 13 Participants |
| Sham Then Real | Feasibility - User Compliance in Wearing the Device | Compliance Month 1 | 12 Participants |
| Sham Then Real | Feasibility - User Compliance in Wearing the Device | Compliance Month 2 | 12 Participants |
Primary
Safety - Occurrence of Device-Related Adverse Events (AE)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Real Then Sham | Safety - Occurrence of Device-Related Adverse Events (AE) | AE Month 1 | 2 Participants |
| Real Then Sham | Safety - Occurrence of Device-Related Adverse Events (AE) | AE Month 2 | 0 Participants |
| Sham Then Real | Safety - Occurrence of Device-Related Adverse Events (AE) | AE Month 1 | 4 Participants |
| Sham Then Real | Safety - Occurrence of Device-Related Adverse Events (AE) | AE Month 2 | 1 Participants |