Trial Outcomes & Findings for Telerehabilitation Early After Stroke (NCT NCT04657770)

NCT ID: NCT04657770

Last Updated: 2023-04-19

Results Overview

Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment. We will be measuring change in scores from baseline to end of treatment (60 days).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2023-04-19

Participant Flow

Participant milestones

Measure	Telerehabilitation Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Telerehabilitation Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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 Withdrawal by Subject	3
Overall Study Completed training but withdrew before follow-up testing due to change in medical status	1

Baseline Characteristics

Telerehabilitation Early After Stroke

Baseline characteristics by cohort

Measure	Telerehabilitation n=19 Participants Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	8 Participants n=5 Participants
Race (NIH/OMB) White	7 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	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment.

We will be measuring change in scores from baseline to end of treatment (60 days).

Outcome measures

Measure

Telerehabilitation n=15 Participants Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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.

Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)

18.07 units on a scale Standard Deviation 10.85

Adverse Events

Telerehabilitation

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telerehabilitation n=19 participants at risk Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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.
General disorders Sepsis	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment
Respiratory, thoracic and mediastinal disorders Pneumonia	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment
Nervous system disorders Recurrent stroke	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment
Musculoskeletal and connective tissue disorders Shoulder injury	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment

Other adverse events

Measure	Telerehabilitation n=19 participants at risk Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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.
Nervous system disorders Nausea	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment
Psychiatric disorders Depression	5.3% 1/19 • Number of events 1 • For each subject, from baseline to 10 weeks post-enrollment

Additional Information

Steve Cramer

UCLA

Phone: 424-522-7273

Email: SCCramer@mednet.ucla.edu

Results disclosure agreements

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