Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity

Status unconfirmed · Not applicable

Conditions studied: Stroke, Hemiparesis

In brief

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 affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.

Key facts

Study ID

NCT03431025

Run by

BioSensics

People needed

60

Starts

2019-03-28

Expected to finish

2021-08-31

Last updated by the study team

2021-03-02

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.