Telerehabilitation Early After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Telerehabilitation

• Registration Number: NCT04657770
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-05-13
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Results First Submitted: 2023-03-20
• Results First Submitted QC: 2023-03-20
• Status Verified: 2023-04
• Results First Posted: 2023-04-12
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

California Rehabilitation Institute; 🇺🇸 Los Angeles, California, United States

Moss Rehabilitation Research Institute; 🇺🇸 Elkins Park, Pennsylvania, United States