Heart-Brain Retraining for Stroke Rehabilitation
Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation
Přehled studie
Postavení
Podmínky
Detailní popis
Stroke is the leading cause of disability in the United States with approximately 795,000 new or recurrent strokes per year. An estimated two thirds of patients post-stroke cannot incorporate the affected upper extremity (UE) into their activities of daily living. In addition, stroke survivors experience a 60% decrease in cardiovascular capacity, which contributed to disability and diminished quality of life. Developing rehabilitation techniques to optimize motor recovery while improving cardiovascular endurance would benefit the stroke population.
Animal studies using a forced exercise (FE) paradigm, in which the rodent is exercised on a motorized treadmill at a rate greater than its voluntary rate, indicate an endogenous increase in neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and glial-derived neurotrophic factor (GDNF). These neurotrophic factors are thought to underlie neuroplasticity and motor learning. It is hypothesized that patients with stroke, due to decreased motor cortical output, cannot sustain high rates of voluntary exercise necessary to trigger the endogenous release of neurotrophic factors; therefore, forced-exercise is necessary to augment their voluntary efforts and will be superior to voluntary exercise in facilitating motor recovery. When coupled with repetitive task practice (RTP) of the UE, an effective form of UE rehabilitation, FE will prime the brain for neuroplasticity. We have developed a safe and effective method of delivering forced-exercise to Parkinson's disease (PD) patients (NIH R21HD056316). Clinical and imaging data with PD patients indicate forced-exercise, but not voluntary exercise, triggers a neurophysiologic response in the central nervous system resulting in global improvements in motor and non-motor functioning and increased cortical and subcortical activation. The aim of this project is to conduct a preliminary trial to compare the effects of forced to voluntary exercise when coupled with RTP in promoting the recovery of motor function in patients with stroke.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Able to provide informed consent
- Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging
- Fugl-Meyer Motor Score 19-55 in involved upper extremity
- Approval from patient's primary care physician
- Age between 18 and 85 years
Exclusion Criteria:
- Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
- Serious cardiac arrhythmia
- Hypertrophic cardiomyopathy
- Severe aortic stenosis
- Cardiac pacemaker
- Pulmonary embolus
- Other medical or musculoskeletal contraindication to exercise
- Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
- Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
- Pregnancy
Studijní plán
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 |
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Aktivní komparátor: Repetitive Task Practice (RTP)
This group focuses on RTP.
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This group will preform arm and hand therapy.
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Experimentální: Voluntary cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
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This group will preform arm and hand therapy and cycle on a bike.
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Experimentální: Assisted cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
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This group will preform arm and hand therapy and cycle on a bike.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Wolf Motor Function Test (WMFT)
Časové okno: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE.
Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Fugl-Meyer Assessment (FMA)
Časové okno: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This is a 33 item assessment of post-stroke UE impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The Stroke Impact Scale (SIS)
Časové okno: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This is a self-reported questionnaire evaluating quality of life.
Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9.
- Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25.
- Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10.
- Linder SM, Rosenfeldt AB, Rasanow M, Alberts JL. Forced Aerobic Exercise Enhances Motor Recovery After Stroke: A Case Report. Am J Occup Ther. 2015 Jul-Aug;69(4):6904210010p1-8. doi: 10.5014/ajot.2015.015636.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R03HD073566 (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 .
Klinické studie na Repetitive Task Practice (RTP)
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University of CincinnatiNeznámý