Long-term Telerehabilitation for Patients With Stroke

NCT03460587 | Completed Results FDA Device

• 1 other identifier: 17IRG3346039
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current protocol is to study 40 patients, each for 12 weeks, to address hypotheses related to the ability of a telerehabilitation system to (a) improve motor status and disability, (b) collect various forms of patient data from the home, (c) improve risk factor knowledge and control, and (d) assess patient compliance with home-based telerehabilitation. Patients who have returned to their home after stroke will be provided with a telehealth system and be asked to use it 6 days/week for 12 weeks, during which time subjects will use this system for daily rehabilitation therapy, assessments, and education--all on one platform.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Arm Motor Scale

  measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

  90 days

Secondary Outcomes (1)

• Fugl-Meyer Leg Motor Scale

  90 days

Study Arms (1)

Home-based Telerehabilitation

EXPERIMENTAL

Home-based Telerehabilitation

Device: Telerehabilitation

Interventions

Telerehabilitation DEVICE

The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home 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 home-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.

Home-based 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 at the time of randomization
• Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage or subarachnoid hemorrhage, and with any time of stroke onset prior to randomization
• Arm motor Fugl Meyer score of 28-66; if Arm motor Fugl Meyer score\> 59, must also have Box \& Blocks on affected side \>25% lower
• Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at the first visit
• Informed consent signed by the subject
• Behavioral contract signed by the subject

You may not qualify if:

• A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia
• A diagnosis (apart from the index stroke) that substantially affects paretic arm function
• A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
• Severe depression, defined as Geriatric Depression Scale Score \>11
• 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
• 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 prior to completion of participation in this study
• Unable to successfully perform all 3 of the rehabilitation exercise test examples
• Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy, or expectation that subject will be unable to participate in study visits
• Concurrent enrollment in another investigational study
• 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 12 weeks of therapy, within 75 miles of the central study site

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (4)

• Dodakian L, McKenzie AL, Le V, See J, Pearson-Fuhrhop K, Burke Quinlan E, Zhou RJ, Augsberger R, Tran XA, Friedman N, Reinkensmeyer DJ, Cramer SC. A Home-Based Telerehabilitation Program for Patients With Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):923-933. doi: 10.1177/1545968317733818. Epub 2017 Oct 26.

  PMID: 29072556 BACKGROUND

• Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.

  PMID: 21482550 BACKGROUND

• Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.

  PMID: 10421300 BACKGROUND

• Cramer SC, Dodakian L, Le V, McKenzie A, See J, Augsburger R, Zhou RJ, Raefsky SM, Nguyen T, Vanderschelden B, Wong G, Bandak D, Nazarzai L, Dhand A, Scacchi W, Heckhausen J. A Feasibility Study of Expanded Home-Based Telerehabilitation After Stroke. Front Neurol. 2021 Feb 3;11:611453. doi: 10.3389/fneur.2020.611453. eCollection 2020.

  PMID: 33613417 DERIVED

MeSH Terms

Conditions

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

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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: Steven C. Cramer, MD
• Organization: UCLA

sccramer@mednet.ucla.edu

424-522-7273

Study Officials

• Steven Cramer, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

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 of Neurology

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 9, 2018
• Study Start: August 29, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)