Trial Outcomes & Findings for Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke (NCT NCT02360488)

Last Updated: 2020-02-28

Results Overview

The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

124 participants

Primary outcome timeframe

from the Baseline Visit to the 30 Day Follow Up Visit

Results posted on

2020-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Telerehabilitation Therapy The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	In-Clinic Therapy The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Overall Study STARTED	62	62
Overall Study COMPLETED	59	55
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telerehabilitation Therapy n=62 Participants The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	In-Clinic Therapy n=62 Participants The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.	Total n=124 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 14 • n=5 Participants	60 years STANDARD_DEVIATION 13 • n=7 Participants	61 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants
Arm motor Fugl-Meyer score	42.8 units on a scale STANDARD_DEVIATION 7.8 • n=5 Participants	42.7 units on a scale STANDARD_DEVIATION 8.7 • n=7 Participants	42.8 units on a scale STANDARD_DEVIATION 8.3 • n=5 Participants

PRIMARY outcome

Timeframe: from the Baseline Visit to the 30 Day Follow Up Visit

Population: Intention-to-Treat with multiple imputation of missing outcomes

Outcome measures

Outcome measures
Measure	Telerehabilitation Therapy n=62 Participants The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	In-Clinic Therapy n=62 Participants The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy	7.86 units on a scale Standard Deviation 6.68	8.36 units on a scale Standard Deviation 7.04

Adverse Events

Telerehabilitation Therapy

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

In-Clinic Therapy

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Telerehabilitation Therapy n=62 participants at risk The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	In-Clinic Therapy n=62 participants at risk The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Cardiac disorders Dizziness	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Cardiac disorders Hypertension	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Ear and labyrinth disorders Fall	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Musculoskeletal and connective tissue disorders Limb fracture	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Nervous system disorders Subdural hemorrhage	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.

Other adverse events

Other adverse events
Measure	Telerehabilitation Therapy n=62 participants at risk The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	In-Clinic Therapy n=62 participants at risk The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Musculoskeletal and connective tissue disorders Arm/shoulder pain	16.1% 10/62 • Number of events 10 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	6.5% 4/62 • Number of events 4 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Nervous system disorders Fatigue	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Cardiac disorders Hypotension	0.00% 0/62 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.	1.6% 1/62 • Number of events 1 • Baseline to 30 days post-therapy Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.

Additional Information

Steve Cramer

UCLA

Phone: 424-522-7273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place