Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background: Among the impairments associated to Parkinson's disease, the gait disturbance is one of which that has the most negative impact on the independence in daily living activities and quality of life of people living with Parkinson's disease. Despite the considerable amount of research, we have no consensus about the most efficient physiotherapeutic approach to improve the gait disturbance. Mental practice is considered an efficient strategy to improve the motor performance in healthy individuals and people with stroke. However, there is scarce evidence about its therapeutic results to improve the gait performance in people living with Parkinson's disease.
Objectives: To investigate the effects of mental gait practice associated with physical practice to improve the gait performance of people living with Parkinson's disease.
Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.
Setting: Brazilian Parkinson Association.
Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease evolution according to Hoehn and Yahr Classification.
Interventions: The participants will be randomly allocated in an experimental group and a control group. Both groups will perform 10 individual training sessions, two times per week, for five weeks. The training sessions consist of four blocks of mental practice intercalated with four blocks of physical practice of gait under different conditions. The only difference between the groups will be the content of mental practice blocks: the experimental group will perform mental practice of gait while the control group performs non-gait mental practice.
Randomization: Participants will be randomized by ClinStat software into one of two groups: Experimental Group (EG), which will perform gait mental practice; and Control Group (CG), which will perform the non-gait mental practice.
Statistical analysis: The training effects for each primary and secondary outcome measure will be analyzed for the two training conditions (i.e., control and experimental) at the four assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day follow-up) using a mixed-design ANOVA with training as the between-group factor and the assessment time point as the within-group factor. The effect sizes (ES) will be calculated for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple comparisons and p-values below 5 % will be considered as statistically significant.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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São Paulo, Brasil, 04142-092
- Brazil Parkinson Association
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria;
- in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
- treated with levodopa or its synergists;
- capable to walk independently indoors without aid;
- referring 5 years of education or more.
Exclusion Criteria:
- presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
- visual and auditory deficiency uncorrected;
- dementia [assessed by Montreal Cognitive Assessment (MoCA), cut-off 26];
- depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6];
- declined imagery capacity [according to the Revised Movement Imagery Questionnaire (MIQ-R) cut-off 10].
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Eksperimentell gruppe (EG)
Eksperimentell trening (ET) består av 10 økter med 4 blokker MP (GMP) interkalert med 4 blokker med gang fysisk trening (GPP), under enkelt (ST) og dual-task (DT) forhold.
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Hver blokk med MP består av 5 mentale gangforsøk med 10 tenkte trinn. Deltakere som sitter komfortabelt med lukkede øyne, vil bli bedt om å forestille seg at de går i et førstepersonsperspektiv, uten noen åpenbar fysisk bevegelse, under fire forskjellige forhold: vanlig hastighet, så fort som mulig, overvinne hindringer og huske et navn på en spesifikk medisin. Hver blokk med PP består av 5 fysiske gangforsøk, med 10 trinn. Deltakerne vil bli bedt om å gå under 4 forskjellige forhold: vanlig hastighet, så fort som mulig, overvinne hindringer og huske navnet på en bestemt medisin. |
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Aktiv komparator: Control Group
The Control training (CT) consists of 10 sessions with 4 blocks of MP (nGMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.
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Hver blokk med MP består av 5 mentale gangforsøk med 10 tenkte trinn. Deltakere som sitter komfortabelt med lukkede øyne, vil bli bedt om å se for seg å sitte og sette pris på et vakkert landskap i et førstepersonsperspektiv, uten noen åpenbar fysisk bevegelse, i fire forskjellige sammenhenger: i en vogn, i en luftballong, i en båt og i en zepelin. Hver blokk med PP består av 5 fysiske gangforsøk, med 10 trinn. Deltakerne vil bli bedt om å gå under 4 forskjellige forhold: vanlig hastighet, så fort som mulig, overvinne hindringer og huske navnet på en bestemt medisin. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Seks minutters gangetest
Tidsramme: opptil 3 måneder
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Seks-minutters gangtesten (6-MWT) er en tidsbestemt anbefalt klinisk basert test der deltakerne blir bedt om å gå i 6 minutter, i sin vanlige hastighet, så lang avstand som mulig.
Avbrudd for hvile er tillatt ved behov.
6-MWT har vist tilstrekkelig test-retest og interterrater-pålitelighet og minimal detekterbar endring på 82 meter i PD.
Det kan være en god prediktor for evnen til selvstendig å gå trygt ute.
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opptil 3 måneder
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Postural Instability and Gait Difficulty Score
Tidsramme: up to 3 months
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Postural Instability and Gait Difficulty Score (PIGD): This recommended rating scale for evaluation of gait alterations in PD is based on 5 Unified Parkinson's Disease Rating Scale (UPDRS) items relevant to gait and postural instability (items 13-15, 29, and 30).
The 13-15 items are based on gait performance according to PPD perspective, while 29 and 30 items are based on the motor test.
It is a recent rating scale that has been used in PD, evaluated independently, which has adequate clinimetric characteristics.
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up to 3 months
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Dynamic Gait Index
Tidsramme: up tp 3 months
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The balance during the eight gait related activities is scored in this test.
These include quality of walking speed change, going around and over obstacles and stair walking, as well as the number of steps required for a pivot turn.
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up tp 3 months
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30-second dual task gait
Tidsramme: up tp 3 months
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It measures the maximal walking distance reached in 30 seconds under single task, i.e., without another concurrent task, and dual task, i.e., with a concurrent cognitive task.
The cognitive task consists of speaking as many words as possible, starting with a specific character (F, S or A), presented at the beginning of test.
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up tp 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Trail Making Test
Tidsramme: up to 3 months
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This test is constituted with two-timed parts: Part A, which involves a visual-scanning task where the participant is required to draw lines sequentially connecting consecutively numbered circles (1-25) randomly arranged on a page as fast as possible.
Part B, which assesses cognitive flexibility, where the participant is asked to connect the same number of circles in an alternating sequence of numbers and letters (1, A, 2, B, etc.).
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up to 3 months
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39-item Parkinson's Disease Questionnaire
Tidsramme: up to 3 months
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This scale assesses the health-related quality of life, i.e., the impact of an illness and/or treatment on patients' perception of their status of health and on subjective well-being or satisfaction with life.
It evaluates 39 parameters in eight groups of issues (mobility, ADL, emotional well-being, stigma of the disease, back in the next, cognitive, communication and bodily discomfort).
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up to 3 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Maria Elisa P Piemonte, PhD, Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Studierekorddatoer
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