Clinical trial NCT02904837: Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
Official title: Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Randomized clinical trial
Parkinson's disease
Mental practice
Gait
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 20
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 to Parkinson's disease, 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. Thus, the aim of this study is to investigate the effects of gait mental practice associated to physical practice to improve the gait performance in people living with Parkinson's disease.

Detailed description: 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.

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 tp 3 months
measure: 30-second dual task gait
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: