Telerehabilitation Early After Stroke

Stroke Clinical Trial

Official title:

Telerehabilitation Early After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657770
• Other study ID #: 20-000994
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: June 22, 2022

Study information

• Verified date: April 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Moss Rehabilitation Research Institute	Elkins Park	Pennsylvania
United States	California Rehabilitation Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Moss Rehabilitation Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	60 days