Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

6. november 2012 opdateret af: Cynthia Bedeschi Ferrari, University of Sao Paulo

Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.

The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.

Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:

  • the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
  • the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.

It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one.

The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.

The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • São Paulo, Brasilien
        • Rekruttering
        • Brazil Parkinson Association
        • Kontakt:
        • Ledende efterforsker:
          • Cynthia B Ferrari, PhD Student

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

50 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
  • In use of dopaminergic medication;
  • Disease severity of 1 to 3 according to Hoehn & Yahr scale;
  • Absence of other neurological disorders or co-morbidities that may affect gait;
  • Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
  • Vision and hearing adequate or corrected to normal;
  • Ability to walk independently;
  • Absence of prolonged off state;
  • Age 50 to 85 years.

Exclusion Criteria:

  • Biomechanical alterations (other pathologies) that could compromise the completion of training;
  • Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
  • Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
  • Any changes in drug treatment for PD.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gait training executive functions tasks
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
Adfærdsmæssigt: Gangtræning eksekutivfunktionsopgaver
Træningen vil bestå af 10 sessioner, to gange om ugen i fem uger, og består af 30 minutters globale øvelser, der involverer stræk-, muskelstyrke- og aksiale mobilitetsøvelser, og yderligere 30 minutters gangtræning i en dual-task tilstand forbundet med distraherende opgaver, der kræver håndtering af de vigtigste eksekutive funktioner: vilje, selvbevidsthed, planlægning, responshæmning, responsovervågning og opmærksomhed.
Aktiv komparator: Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
Adfærdsmæssigt: Gait training alone
The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamic Gait Index
Tidsramme: 05/2013 (Up to ten months)
The scale assesses the ability to adapt the gait during motor tasks with different demands.
05/2013 (Up to ten months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Montreal Cognitive Assessment
Tidsramme: 05/2013 (Up to ten months)
This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
05/2013 (Up to ten months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Samarbejdspartnere

Coordination for the Improvement of Higher Education Personnel

Efterforskere

  • Studieleder: Maria Elisa P Piemonte, PhD, University of Sao Paulo
  • Ledende efterforsker: Cynthia B Ferrari, PhD Student, University of Sao Paulo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Forventet)

1. maj 2013

Studieafslutning (Forventet)

1. juli 2013

Datoer for studieregistrering

Først indsendt

19. juli 2012

Først indsendt, der opfyldte QC-kriterier

23. juli 2012

Først opslået (Skøn)

26. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • USPNEC002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Parkinsons sygdom

Kliniske forsøg med Gangtræning eksekutivfunktionsopgaver

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Montenegro

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner