Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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São Paulo, Brasilien
- Rekrytering
- Brazil Parkinson Association
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Kontakt:
- Grossmann, President
- Telefonnummer: 55-11-25788177
- E-post: parkinson@parkinson.org.br
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Huvudutredare:
- Cynthia B Ferrari, PhD Student
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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).
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Träningen kommer att bestå av 10 pass, två gånger per vecka under fem veckor, och består av 30 minuters globala övningar som innebär stretching, muskelförstärkningsövningar och axiell rörlighet, och ytterligare 30 minuters gångträning i ett tillstånd med två uppgifter i samband med distraherande uppgifter som kräver hantering av de huvudsakliga exekutiva funktionerna: vilja, självkännedom, planering, responshämning, responsövervakning och uppmärksamhet.
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Aktiv komparator: Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Dynamic Gait Index
Tidsram: 05/2013 (Up to ten months)
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The scale assesses the ability to adapt the gait during motor tasks with different demands.
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05/2013 (Up to ten months)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Montreal Cognitive Assessment
Tidsram: 05/2013 (Up to ten months)
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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.
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05/2013 (Up to ten months)
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Maria Elisa P Piemonte, PhD, University of Sao Paulo
- Huvudutredare: Cynthia B Ferrari, PhD Student, University of Sao Paulo
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USPNEC002
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