Deficit Fields for Stroke Recovery
8. června 2021 aktualizováno: James Patton, Shirley Ryan AbilityLab
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
This study investigates the potential of customized robotic and visual feedback interaction to improve recovery of movements in stroke survivors.
While therapists widely recognize that customization is critical to recovery, little is understood about how take advantage of statistical analysis tools to aid in the process of designing individualized training.
Our approach first creates a model of a person's own unique movement deficits, and then creates a practice environment to correct these problems.
Experiments will determine how the deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3) activities of daily living.
The findings will not only shed light on how to improve therapy for stroke survivors, it will test hypotheses about fundamental processes of practice and learning.
This study will help us move closer to our long-term goal of clinically effective treatments using interactive devices.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
45
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Illinois
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Chicago, Illinois, Spojené státy, 60611
- Rehabilitation Institute of Chicago
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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 až 100 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
STROKE SURVIVORS:
- adult (age >18)
- Chronic stage stroke recovery (8+ months post)
- available medical records and radiographic information about lesion locations
- strokes caused by an ischemic infarct in the middle cerebral artery
- primary motor cortex involvement
- a Fugl-Meyer score (between 15-50) to evaluate arm motor impairment level
HEALTHY CONTROL PARTICIPANTS:
- adult (age >18)
- healthy individuals with no history of stroke or neural injury
Exclusion Criteria:
- bilateral paresis;
- severe sensory deficits in the limb
- severe spasticity (Modified Ashworth of 4) preventing movement
- aphasia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
- inability to provide an informed consent
- severe current medical problems
- diffuse/multiple lesion sites or multiple stroke events
- hemispatial neglect or visual field cut that would prevent subjects from seeing the targets.
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: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Deficit-fields to reduce error
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
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Stroke survivors exhibit error in both reaching extent and abnormal curvatures of motion.
Prior error augmentation techniques multiply error by a constant at each instant during movement.
However, magnification of spurious errors may provoke over-compensation.
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
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Experimentální: Deficit-fields to expand range of motion
Amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
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Motor deficits manifest in the workspace limitations of joints, i.e. reduced range of motion, uneven extension-flexion, inter-joint coupling, and unwanted synergies.
Our work builds upon these ideas by augmenting self-directed movement for training coordination.
We found that amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
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Experimentální: Deficit-fields to improve function
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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Clinicians have recognized the benefits of training on everyday tasks (Hubbard, Parsons et al. 2009), as well as practice with whole-body actions (Boehme 1988; Bohannon 1995).
However, typical robotic systems have only a single contact point and cannot drive the multiple joints involved in functional tasks.
Visual distortions (e.g. a shift, rotation or stretch) can promote adaptation even without forces.
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Arm motor recovery scores on the Fugl-Meyer
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in arm motor recovery as measured by Fugl-Meyer
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of blocks transferred in Box and Blocks Test
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in number of blocks transferred during Box and Blocks Test
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Modified Ashworth Scale (MAS)
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in amount of spasticity in elbow flexors and extensors
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Elbow active range of motion (ROM)
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline measured in degrees for elbow flexion and extension
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Chedoke McMaster Stroke Assessment for Hand
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline in amount of hand motor recovery as measured by Chedoke scale
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Time and completion score for Action Research Arm Test (ARAT)
Časové okno: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline score and time for completion of functional measures as part of ARAT
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: James L Patton, PhD, Shirley Ryan AbilityLab
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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 (Aktuální)
1. května 2013
Primární dokončení (Aktuální)
30. června 2019
Dokončení studie (Aktuální)
30. června 2019
Termíny zápisu do studia
První předloženo
1. října 2015
První předloženo, které splnilo kritéria kontroly kvality
6. října 2015
První zveřejněno (Odhad)
7. října 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. června 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. června 2021
Naposledy ověřeno
1. října 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RehabilitationIC
- 2R01NS053606-05A1 (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 .