- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01723046
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lore Van de Perre, MSc
- Telefonnummer: +32 14 56 23 10
- E-Mail: lore.van.de.perre@khk.be
Studienorte
-
-
Antwepen
-
Geel, Antwepen, Belgien, 2440
- Thomas More Kempen
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Kontakt:
- Lore Van de Perre, MSc
- Telefonnummer: +32 14 56 23 10
- E-Mail: lore.van.de.perre@khk.be
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Kontakt:
- Peter Karsmakers, PhD
- Telefonnummer: +32 14 56 23 10
- E-Mail: peter.karsmakers@khk.be
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Hauptermittler:
- Lore Van de Perre, MSc
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Unterermittler:
- Roy Sevit, MSc
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Unterermittler:
- Koen Janssens, MSc
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Unterermittler:
- Peter Karsmakers, PhD
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Unterermittler:
- Louis Peeraer, Prof.PhD
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Andere Namen:
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Kein Eingriff: Control group
The control group is treated with conventional therapy.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Fugl-Meyer test upper limb section
Zeitfenster: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
|
Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
|
Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
Zeitfenster: Change from baseline Medical research council score at 8 weeks and 12 weeks
|
Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
|
Active range of motion of the elbow joint
Zeitfenster: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
|
The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
Zeitfenster: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
|
The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
Zeitfenster: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
|
Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
ABILHAND questionnaire
Zeitfenster: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
Zeitfenster: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
Zeitfenster: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
Zeitfenster: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
|
Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lore Van de Perre, MSc, Thomas More Kempen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IWT120278
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