- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02570256
Deficit Fields for Stroke Recovery
8. juni 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rehabilitation Institute of Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Arm motor recovery scores on the Fugl-Meyer
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of blocks transferred in Box and Blocks Test
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James L Patton, PhD, Shirley Ryan AbilityLab
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
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Studer store datoer
Studiestart (Faktiske)
1. maj 2013
Primær færdiggørelse (Faktiske)
30. juni 2019
Studieafslutning (Faktiske)
30. juni 2019
Datoer for studieregistrering
Først indsendt
1. oktober 2015
Først indsendt, der opfyldte QC-kriterier
6. oktober 2015
Først opslået (Skøn)
7. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2021
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RehabilitationIC
- 2R01NS053606-05A1 (U.S. NIH-bevilling/kontrakt)
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