Telerehabilitation Early After Stroke

NCT ID: NCT04657770

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2022-06-22

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older

2. Stroke that has been radiologically verified

3. Arm motor FM score <56 (out of 66) at initial visit

4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit

5. Informed consent and behavioral contract signed by the subject

6. Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation

Exclusion Criteria

1. A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)

2. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures

3. Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit

4. Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)

5. Deficits in communication that interfere with reasonable study participation

6. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye

7. Life expectancy <6 months

8. Pregnant

9. 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

10. Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy

11. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

12. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moss Rehabilitation Research Institute

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Steven C. Cramer, MD, FAAN, FAHA

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

California Rehabilitation Institute

Los Angeles, California, United States

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States

Countries

United States

References

Edwards D, Kumar S, Brinkman L, Ferreira IC, Esquenazi A, Nguyen T, Su M, Stein S, May J, Hendrix A, Finley C, Howard E, Cramer SC. Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):131-141. doi: 10.1177/15459683231159660. Epub 2023 Mar 6.

Reference Type: DERIVED

PMID: 36876946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-000994

Identifier Type: -

Identifier Source: org_study_id