- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01121627
Computer-based Cognitive Training for Parkinson Disease
Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.
The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Haifa, Israel
- Clalit Health Services, Haifa and Western Galilee District
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Idiopathic PD.
- Aged 50-80, living in north region of Israel.
- Receive regular medications for PD.
- Not suffering from irregular cognitive disturbance or MMSE<25.
- Measured 1-3 on the Hoehn & Yahr scale.
- Have access to a computer and the ability to operate it.
Exclusion Criteria:
- Brain operation, including DBS transplant.
- History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
- Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
- Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
- Inability to walk independently.
- Immunodeficiency diseases, active cancer, ischemic diseases.
- Vision impairment, partial/full blindness.
- Having participated in similar research or cognitive assessment during the previous year.
- Have received cognitive or gait training under physical therapy or other programs.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Computerized cognitive training
A 12 week computerized cognitive training
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A 12 week computerized cognitive training at home with the Attengo™ software program.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gait Function
Zeitfenster: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
|
18 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Executive function
Zeitfenster: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
|
18 weeks
|
|
Quality of life.
Zeitfenster: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes.
|
18 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Uzi Milman, MD, Clalit Health Services
- Hauptermittler: Anat Mirelman, Phd, Tel-Aviv Sourasky Medical Center
- Hauptermittler: Hagit Atias, BA, Clalit Health Services
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
- K-10-0036-ctil
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