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

NCT ID: NCT03431025

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2021-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Wearable sensors and biofeedback

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

BioSensics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph T Gwin, PhD

Role: PRINCIPAL_INVESTIGATOR

BioSensics

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine Adans-Dester, PT

Role: CONTACT

cadans-dester@partners.org

617-952-6321

Facility Contacts

Catherine Adans-Dester, PT

Role: primary

cadans-dester@partners.org

617-952-6321

Other Identifiers

2016P001688/SRH

Identifier Type: -

Identifier Source: org_study_id