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

NCT02904837 | Completed DMC

• 1 other identifier: Pikel 01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Randomized clinical trial; Parkinson's disease; Mental practice; Gait

Outcome Measures

Primary Outcomes (4)

• Postural Instability and Gait Difficulty Score

  Postural Instability and Gait Difficulty Score (PIGD): This recommended rating scale for evaluation of gait alterations in PD is 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. It is a recent rating scale that has been used in PD, evaluated independently, which has adequate clinimetric characteristics.

  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 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.

  up tp 3 months

• 30-second dual task gait

  It measures the maximal walking distance reached in 30 seconds under single task, i.e., without another concurrent task, and dual task, i.e., with a concurrent cognitive task. 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.

  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

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

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

Study Sites (1)

Brazil Parkinson Association

São Paulo, 04142-092, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

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: September 9, 2016
• First Posted: September 19, 2016
• Study Start: March 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 19, 2018

Record last verified: 2016-09

Locations

BR (1)