Computer-based Cognitive Training for Parkinson Disease
21. august 2015 oppdatert av: Uzi Milman, Clalit Health Services
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Parkinson 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.
Previous studies have revealed some relation between cognitive states and physical functions in healthy adults.
Few studies have examined the effect of computer-based cognitive training on various populations.
These studies showed a positive emotional-cognitive effect in those populations.
This type of intervention plan was also applied to PD patients.
However, there are no reports on the effect of intentional cognitive training on gait functions.
The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Haifa, Israel
- Clalit Health Services, Haifa and Western Galilee District
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait Function
Tidsramme: 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.
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18 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Executive function
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Uzi Milman, MD, Clalit Health Services
- Hovedetterforsker: Anat Mirelman, Phd, Tel-Aviv Sourasky Medical Center
- Hovedetterforsker: Hagit Atias, BA, Clalit Health Services
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2010
Primær fullføring (Faktiske)
1. april 2012
Studiet fullført (Faktiske)
1. april 2012
Datoer for studieregistrering
Først innsendt
10. mai 2010
Først innsendt som oppfylte QC-kriteriene
10. mai 2010
Først lagt ut (Anslag)
12. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K-10-0036-ctil
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .