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

Stroke Clinical Trial

Official title:

Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431025
• Other study ID #: 2016P001688/SRH
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2021
• Source: BioSensics
• Contact: Catherine Adans-Dester, PT
• Phone: 617-952-6321
• Email: cadans-dester[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
BioSensics	Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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	Change in Wolf Motor Function Test time-subscale during intervention	Change in Wolf Motor Function Test time-subscale score from baseline (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)	12 weeks
Secondary	Change in Wolf Motor Function Test quality-subscale during intervention	Change in Wolf Motor Function Test quality-subscale score from baseline (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)	12 weeks
Secondary	Change in Wolf Motor Function Test time-subscale during washout	Change in Wolf Motor Function Test time-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)	12 weeks (end of intervention), 20 weeks (follow-up)
Secondary	Change in Wolf Motor Function Test quality-subscale during washout	Change in Wolf Motor Function Test quality-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)	12 weeks (end of intervention), 20 weeks (follow-up)