Clinical trial NCT03431025: Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
Official title: Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiparesis
Lead sponsor: BioSensics
Sponsor class: INDUSTRY
Collaborators: name: Spaulding Rehabilitation Hospital
First posted: 2018-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Fugl-Meyer during intervention
timeFrame: 12 weeks
measure: Change in Motor Activity Log Quality Score during intervention
timeFrame: 12 weeks
measure: Change in Motor Activity Log Quantity Score during intervention
timeFrame: 12 weeks
measure: Change in Fugl-Meyer during washout
timeFrame: 12 weeks (end of intervention), 20 weeks (follow-up)
measure: Change in Motor Activity Log Quality Score during washout
timeFrame: 12 weeks (end of intervention), 20 weeks (follow-up)
measure: Change in Motor Activity Log Quantity Score during washout
timeFrame: 12 weeks (end of intervention), 20 weeks (follow-up)
Secondary outcomes:
measure: Change in Wolf Motor Function Test time-subscale during intervention
timeFrame: 12 weeks
measure: Change in Wolf Motor Function Test quality-subscale during intervention
timeFrame: 12 weeks
measure: Change in Wolf Motor Function Test time-subscale during washout
timeFrame: 12 weeks (end of intervention), 20 weeks (follow-up)
measure: Change in Wolf Motor Function Test quality-subscale during washout
timeFrame: 12 weeks (end of intervention), 20 weeks (follow-up)
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: BioSensics
name: Joseph T Gwin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: