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Telerehabilitation Early After Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telerehabilitation

About this trial

This is an interventional treatment trial for Stroke focused on measuring telerehab, telerehabilitation, telehealth, brain plasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

California Rehabilitation Institute
Moss Rehabilitation Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telerehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04657770

First Posted

December 1, 2020

Last Updated

April 17, 2023

Sponsor

University of California, Los Angeles

Collaborators

Moss Rehabilitation Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04657770

Brief Title

Telerehabilitation Early After Stroke

Official Title

Telerehabilitation Early After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 13, 2021 (Actual)

Primary Completion Date

June 22, 2022 (Actual)

Study Completion Date

June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Moss Rehabilitation Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

telerehab, telerehabilitation, telehealth, brain plasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All enrollees will receive telerehabilitation.

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telerehabilitation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Telerehabilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

California Rehabilitation Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90067

Country

United States

Facility Name

Moss Rehabilitation Research Institute

City

Elkins Park

State/Province

Pennsylvania

ZIP/Postal Code

19027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

A deidentified dataset will be shared with appropriate personnel after the main study manuscript is published.

IPD Sharing Time Frame

Likely starting 1-2 years after study completion, lasting for several years thereafter.

IPD Sharing Access Criteria

Data will be shared using common data formats with appropriate personnel.

Learn more about this trial

Telerehabilitation Early After Stroke

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