- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02570256
Deficit Fields for Stroke Recovery
8. Juni 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
45
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Rehabilitation Institute of Chicago
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Arm motor recovery scores on the Fugl-Meyer
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of blocks transferred in Box and Blocks Test
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: James L Patton, PhD, Shirley Ryan AbilityLab
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2013
Primärer Abschluss (Tatsächlich)
30. Juni 2019
Studienabschluss (Tatsächlich)
30. Juni 2019
Studienanmeldedaten
Zuerst eingereicht
1. Oktober 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Oktober 2015
Zuerst gepostet (Schätzen)
7. Oktober 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2021
Zuletzt verifiziert
1. Oktober 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RehabilitationIC
- 2R01NS053606-05A1 (US NIH Stipendium/Vertrag)
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