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

NCT03565965 | Unknown DMC

• 1 other identifier: Pikel 02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Randomized clinical trial; Parkinson's disease; Gait disorders; Locomotor imagery training

Outcome Measures

Primary Outcomes (5)

• Postural Instability and Gait Difficulty Score

  The Postural Instability and Gait Difficulty Score (PIGD) is a recommended rating scale for evaluation of gait alterations in PD 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.

  up to 3 months

• Six-minute Walk Test

  The six-minute walk test (6-MWT) is a timed recommended clinically based test in which participants are asked to walk for 6 minutes, in their habitual speed, as much distance as possible. Interruptions for resting are permitted if necessary. The 6-MWT has demonstrated adequate test-retest and interrater reliability and minimal detectable change of 82 meters in PD. It may be a good predictor of the ability to independently walk outside safely.

  up to 3 months

• Dynamic Gait Index

  The Dynamic Gait Index (DGI) is a test that assess gait balance. It has demonstrated good feasibility, test-retest, interrater reliability and minimal detectable change of 3-point reduction in PD. Furthermore, it is considerable as a supportive test for identifying the fall risk in people with PD. 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. The performance is scored from 0 to 3, with 0 indicating the lowest and 24 the highest level of functioning.

  up to 3 months

• 30 seconds DT gait

  The 30 seconds DT gait (30sDTG) is a test in which measures the maximal walking distance reached in 30 seconds under single and dual taks. 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. This cognitive task showed to be more sensitive for dual task impairment and less prone to education level.

  up to 3 months

• Functional Near Infrared Spectroscopy (fNIS)

  During 30sDTG, the concentration of oxygenated and deoxygenated hemoglobin of the motor and prefrontal regions will be measured. The measuring cap based on the 10-20 international will be set to acquire signal from primary motor cortices and dorsolateral prefrontal cortices. Data will be modelled based on the onset gait time for 30s, automatically defined by trigger markers. The onset and duration of each condition will be convolved with the canonical hemodynamic response function to obtain the regressors. The individual and group measures comparisons, considering the condition with and without dual task will be performed with a significance level of 5%.

  up tp 3 months

Secondary Outcomes (2)

• Trail Making Test

  up to 3 months

• 39-item Parkinson's Disease Questionnaire

  up to 3 months

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Behavioral: Experimental training

Control Group (CG)

ACTIVE COMPARATOR

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.

Behavioral: Control training

Interventions

Experimental training 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.

Experimental Group (EG)

Control training 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.

Control Group (CG)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Brasilia: collaborator
• Universidade Federal do Rio Grande do Norte: collaborator

Study Sites (1)

Brazil Parkinson Association

São Paulo, 04142-092, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Elisa P Piemonte, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 27, 2018

Record last verified: 2018-06

Locations

BR (1)