Trial Outcomes & Findings for Long-term Telerehabilitation for Patients With Stroke (NCT NCT03460587)

NCT ID: NCT03460587

Last Updated: 2020-12-17

Results Overview

measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2020-12-17

Participant Flow

Participant milestones

Measure	Home-based Telerehabilitation Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Telerehabilitation for Patients With Stroke

Baseline characteristics by cohort

Measure	Home-based Telerehabilitation n=13 Participants Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Time post-stroke	129 days n=5 Participants
Arm motor Fugl-Meyer score	46 units on a scale n=5 Participants
Leg motor Fugl-Meyer score	28 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: All patients who signed informed consent.

measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

Outcome measures

Measure

Home-based Telerehabilitation n=13 Participants Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.

Fugl-Meyer Arm Motor Scale

59 units on a scale Interval 52.5 to 61.5

SECONDARY outcome

Timeframe: 90 days

Population: All patients who signed informed consent

measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment

Outcome measures

Measure

Home-based Telerehabilitation n=13 Participants Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.

Fugl-Meyer Leg Motor Scale

28 units on a scale Interval 27.0 to 30.5

Adverse Events

Home-based Telerehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven C. Cramer, MD

UCLA

Phone: 424-522-7273

Email: sccramer@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place