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Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

17. února 2020 aktualizováno: Steven C. Cramer, MD, University of California, Irvine

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Substantial evidence indicates that occupational and physical therapy improves outcomes after stroke, and that larger doses are associated with superior outcomes. However, many patients receive suboptimal doses of therapy for reasons that include cost, access, and difficulty with travel. This problem is likely to increase with time given the aging of the population and the increased rate with which patients survive stroke. Telehealth, defined as the delivery of health-related services and information via telecommunication technologies, has enormous potential to address this unmet need.

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

Telerehabilitation will be evaluated using an assessor-blind, randomized, non-inferiority study design. This study seeks to establish comparable efficacy between the two treatment arms based upon a non-inferiority margin of 2.05 points on the arm motor Fugl-Meyer scale. Key study features include enrollment of a diverse stroke population, standardized and blinded outcomes assessment, a standardized treatment protocol, covariate-adaptive randomization, and use of an active comparator that is matched for duration, frequency, and intensity of therapy. The FDA has determined that this investigation is a non-significant risk device study.

A minimum of 5 clinical sites will participate in this study. Each clinical site will conduct all testing and treatment at a single central site, although each clinical site is encouraged to recruit subjects from their referral hospitals. At the central study site, an Assessment Therapist will perform all study testing, blinded to treatment assignment (the subject by necessity is not blinded), while a Treatment Therapist will provide in-clinic therapy as well as direct home-based telerehabilitation. Potential enrollees may be identified through any of several routes, for example, during the acute stroke admission at the clinical site or a referral hospital, during inpatient rehabilitation at the clinical site or a referral hospital, or through other means of community-based recruitment. Study conduct will be highly standardized, including selecting therapy content, delivering therapy, and testing.

The current study aims to critically evaluate the utility of a telehealth approach to motor therapy and stroke education. Telehealth has enormous potential to address unmet needs in the growing population of stroke survivors.

Typ studie

Intervenční

Zápis (Aktuální)

124

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Irvine, California, Spojené státy, 92697
        • University of California, Irvine
      • San Diego, California, Spojené státy, 92103
        • UCSD Stroke Center
    • Florida
      • Jacksonville, Florida, Spojené státy, 32216
        • Brooks Rehabilitation Clinical Research Center
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30322
        • Emory Rehabilitation Hospital
    • Illinois
      • Chicago, Illinois, Spojené státy, 60611
        • Rehabilitation Institute of Chicago
    • Massachusetts
      • Charlestown, Massachusetts, Spojené státy, 02129
        • Spaulding Rehabilitation Hospital
    • New Jersey
      • Saddle Brook, New Jersey, Spojené státy, 07663
        • Kessler Institute for Rehabilitation
    • New York
      • New York, New York, Spojené státy, 10029
        • Mount Sinai
      • White Plains, New York, Spojené státy, 10605
        • Burke Rehabilitation Hospital
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44109
        • MetroHealth Rehabilitation Institute of Ohio
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29425
        • MUSC Center for Rehabilitation Research in Neurological Conditions
    • Washington
      • Seattle, Washington, Spojené státy, 98104
        • Harborview Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion criteria

  1. Age ≥18 years at the time of randomization
  2. Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization
  3. Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit
  4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the Screening Visit
  5. Informed consent signed by the subject
  6. Behavioral contract signed by the subject

Exclusion criteria

  1. A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia
  2. A diagnosis (apart from the index stroke) that substantially affects paretic arm function
  3. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
  4. Severe depression, defined as GDS Score >10
  5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22
  6. Deficits in communication that interfere with reasonable study participation
  7. A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks prior to randomization
  8. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
  9. Life expectancy < 6 months
  10. Pregnant
  11. 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 the 30 Day Follow Up Visit
  12. Unable to successfully perform all 3 of the rehabilitation exercise test examples
  13. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy
  14. Concurrent enrollment in another investigational study
  15. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
  16. Expectation that subject cannot participate in study visits

  17. Expectation that subject will not have a single domicile address during the 6 weeks of therapy, within 25 miles of the central study site and with Verizon wireless reception.**

    • A site may enroll a person who does not meet exclusion criterion # 17 if this is specifically approved by the site's study PI.
    • Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 ("MoCA score cannot be <22") can be waived.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Telerehabilitation Therapy
The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
Přístroj: Telerehabilitation Therapy
18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
Aktivní komparátor: In-Clinic Therapy
The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.
Behaviorální: In-Clinic Therapy
18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy
Časové okno: from the Baseline Visit to the 30 Day Follow Up Visit
The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.
from the Baseline Visit to the 30 Day Follow Up Visit

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of California, Irvine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2015

Primární dokončení (Aktuální)

1. dubna 2018

Dokončení studie (Aktuální)

1. dubna 2018

Termíny zápisu do studia

První předloženo

5. února 2015

První předloženo, které splnilo kritéria kontroly kvality

5. února 2015

První zveřejněno (Odhad)

10. února 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. února 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. února 2020

Naposledy ověřeno

1. února 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1U01NS091951-01A1 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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