Clinical trial NCT03565965: Protocol: Mental Practice Combined With Physical Practice of Gait in Parkinson's Disease.
Official title: Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease: A Multicentre Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Randomized clinical trial
Parkinson's disease
Gait disorders
Locomotor imagery training
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Brasilia
name: Universidade Federal do Rio Grande do Norte
First posted: 2018-06-21
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD. Thus, the aim of this study is to investigate the effects of mental gait practice associated with physical practice (PP) to improve the gait performance of PPD.

Detailed description: Background: Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD.

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: Onde hundred and forty four people living with Parkinson's disease in stages 2-3 disease evolution according to Hoehn and Yahr Classification.

Interventions: The participants will be randomly allocated in an experimental group (EG), and a control group (CG). Both groups will perform 10 individual training sessions, two individual sessions per week, for five weeks. Every session will be guided by a physiotherapist. The training sessions consist of four blocks of MP intercalated with four blocks of PP of gait in single-task (ST) and dual-task (DT) conditions. The only difference between the groups will be the content of mental practice blocks: the EG will perform mental practice of gait (GMP) while the CG will perform non-gait mental practice (nGMP).

Randomization: Participants will be randomized by ClinStat software into one of two groups: Experimental Group (EG), which will perform the GMP; and Control Group (CG), which will perform the nGMP.

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., 7 days pre-intervention and 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.

Eligibility criteria: 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 \[according to the Revised Movement Imagery Questionnaire (MIQ-R) cut-off 10\].

Primary outcomes:
measure: Postural Instability and Gait Difficulty Score
timeFrame: up to 3 months
measure: Six-minute Walk Test
timeFrame: up to 3 months
measure: Dynamic Gait Index
timeFrame: up to 3 months
measure: 30 seconds DT gait
timeFrame: up to 3 months
measure: Functional Near Infrared Spectroscopy (fNIS)
timeFrame: up tp 3 months
Secondary outcomes:
measure: Trail Making Test
timeFrame: up to 3 months
measure: 39-item Parkinson's Disease Questionnaire
timeFrame: up to 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Brazil Parkinson Association
Study officials:
affiliation: Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo
name: Maria Elisa P Piemonte, PhD
role: PRINCIPAL_INVESTIGATOR
References: