Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease

University of Sao Paulo General Hospital

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Control training; Behavioral: Experimental training

Study type: Interventional

Funder types: Other

Identifiers

NCT02904837

Pikel 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental training

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control training