Protocol: Mental Practice Combined With Physical Practice of Gait in Parkinson's Disease.

NCT ID: NCT03565965

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group (EG)

The Experimental training (ET) consists of 10 sessions with 4 blocks of MP (GMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.

Group Type: EXPERIMENTAL

Experimental training

Intervention Type: BEHAVIORAL

Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves walking as of a first-person perspective, without any overt physical movement, in four different conditions: habitual speed, as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Control Group (CG)

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.

Group Type: ACTIVE_COMPARATOR

Control training

Intervention Type: BEHAVIORAL

Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves seated appreciating a beautiful landscape as of a first-person perspective, without any overt physical movement, in four different contexts: in a carriage, in a hot air balloon, in a boat and in a zepelin.

Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Interventions

Experimental training

Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves walking as of a first-person perspective, without any overt physical movement, in four different conditions: habitual speed, as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Intervention Type: BEHAVIORAL

Control training

Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves seated appreciating a beautiful landscape as of a first-person perspective, without any overt physical movement, in four different contexts: in a carriage, in a hot air balloon, in a boat and in a zepelin.

Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication.

Intervention Type: BEHAVIORAL

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].

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: collaborator

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Elisa P Piemonte, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo

Locations

Brazil Parkinson Association

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Pikel 02

Identifier Type: -

Identifier Source: org_study_id