Status:
UNKNOWN
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
Lead Sponsor:
BioSensics
Collaborating Sponsors:
Spaulding Rehabilitation Hospital
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affec...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).
Exclusion
- Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
- Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
- Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
- Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
- Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
- Participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...).
- Recent (\< 3 months) Botox injection in the upper-extremity or plan to undergo injections during the study timeline.
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03431025
Start Date
March 28 2019
End Date
August 31 2021
Last Update
March 2 2021
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129