Recruiting

Tele-Rehabilitation

Sponsor:

BioSensics

Code:

NCT03431025

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Wearable sensors and biofeedback

Study Details

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.

Conditions

Stroke

Hemiparesis

Study ID

NCT03431025

Start date

Mar 28, 2019

Status verified date

Feb, 2021

Completion date

Aug 31, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Participants in the Control Arm will wear sensors to monitor their upper limb movement but will not receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.

experimental: Intervention

Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.

Interventions

Wearable sensors and biofeedback

Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.

Primary outcome measure

  • Change in Fugl-Meyer during intervention [ Time Frame: 12 weeks ]
  • Change in Motor Activity Log Quality Score during intervention [ Time Frame: 12 weeks ]
  • Change in Motor Activity Log Quantity Score during intervention [ Time Frame: 12 weeks ]
  • Change in Fugl-Meyer during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
  • Change in Motor Activity Log Quality Score during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
  • Change in Motor Activity Log Quantity Score during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]

Central Contacts and Locations

Central contacts

Catherine Adans-Dester, PT

617-952-6321cadans-dester@partners.org

Locations

Spaulding Rehabilitation Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Catherine Adans-Dester, PT

617-952-6321cadans-dester@partners.org

More Information

Sponsor

BioSensics

Last update posted

Mar 2, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BioSensics on 2021-03-02.