Telerehabilitation Early After Stroke

NCT04657770 | Completed Results FDA Device

• 1 other identifier: 20-000994
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

telerehab; telerehabilitation; telehealth; brain plasticity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

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

Interventions

Telerehabilitation 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.

Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Moss Rehabilitation Research Institute: collaborator

Study Sites (2)

California Rehabilitation Institute

Los Angeles, California, 90067, United States

Location

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (1)

• 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.

  PMID: 36876946 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Steve Cramer
• Organization: UCLA

SCCramer@mednet.ucla.edu

424-522-7273

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All enrollees will receive telerehabilitation.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: May 13, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: April 19, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Likely starting 1-2 years after study completion, lasting for several years thereafter.
• Access Criteria: Data will be shared using common data formats with appropriate personnel.

Locations

US (2)