Telerehabilitation Early After Stroke

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT04657770

Collaborator

Moss Rehabilitation Research Institute (Other)

Enrollment

Locations

Arm

13.3

Actual Duration (Months)

9.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to assess the feasibility of initiating telerehab in early stages after stroke during patient admission to an inpatient rehabilitation facility. Patients will complete 36 sessions of telerehab 6 days/week up to 8 weeks with a telehealth system provided in their hospital room and at their home. The system will include rehabilitation activities/exercises, education, and assessments to evaluate the patient experience and measure patient outcomes at the end of a 6-week course of telerehab.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Telerehabilitation	N/A

Detailed Description

Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. The research team has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge, when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility. In this study, key areas of interest include issues related to, and the clinical effects of, telerehabilitation that is started during the rehab admission and is continued after discharge in the patient's home.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All enrollees will receive telerehabilitation.All enrollees will receive telerehabilitation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Telerehabilitation Early After Stroke

Actual Study Start Date :

May 13, 2021

Actual Primary Completion Date :

Jun 22, 2022

Actual Study Completion Date :

Jun 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Arm Motor score [60 days]
measure of arm impairment, scores range from 0-66 with higher numbers reflecting less arm impairment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Stroke that has been radiologically verified
Arm motor FM score <56 (out of 66) at initial visit
Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
Informed consent and behavioral contract signed by the subject
Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation

Exclusion Criteria:

A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit
Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
Deficits in communication that interfere with reasonable study participation
Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
Life expectancy <6 months
Pregnant
Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk within 3 months of study enrollment
Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
Expectation that subject will not have a single domicile address during the 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for the telerehab system

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Rehabilitation Institute	Los Angeles	California	United States	90067
2	Moss Rehabilitation Research Institute	Elkins Park	Pennsylvania	United States	19027

Sponsors and Collaborators

University of California, Los Angeles
Moss Rehabilitation Research Institute

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Apr 21, 2021

More Information

Publications

None provided.

Responsible Party:

Steven C. Cramer, MD, FAAN, FAHA, Professor, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT04657770

Other Study ID Numbers:

20-000994

First Posted:

Dec 8, 2020

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Steven C. Cramer, MD, FAAN, FAHA, Professor, University of California, Los Angeles

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 29, 2022