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

NCT03431025 | Unknown

• 1 other identifier: 2016P001688/SRH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Change in Fugl-Meyer during intervention

  Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).

  12 weeks

• Change in Motor Activity Log Quality Score during intervention

  Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  12 weeks

• Change in Motor Activity Log Quantity Score during intervention

  Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  12 weeks

• Change in Fugl-Meyer during washout

  Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).

  12 weeks (end of intervention), 20 weeks (follow-up)

• Change in Motor Activity Log Quality Score during washout

  Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  12 weeks (end of intervention), 20 weeks (follow-up)

• Change in Motor Activity Log Quantity Score during washout

  Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  12 weeks (end of intervention), 20 weeks (follow-up)

Secondary Outcomes (4)

• Change in Wolf Motor Function Test time-subscale during intervention

  12 weeks

• Change in Wolf Motor Function Test quality-subscale during intervention

  12 weeks

• Change in Wolf Motor Function Test time-subscale during washout

  12 weeks (end of intervention), 20 weeks (follow-up)

• Change in Wolf Motor Function Test quality-subscale during washout

  12 weeks (end of intervention), 20 weeks (follow-up)

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Device: Wearable sensors and biofeedback

Interventions

Wearable sensors and biofeedback 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.

Intervention

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BioSensics: lead
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Joseph T Gwin, PhD

  BioSensics

  PRINCIPAL INVESTIGATOR

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Adans-Dester, PT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 13, 2018
• Study Start: March 28, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)