Clinical trial NCT02600728: Training Based On Declarative Memory Cues Improved Gait In Patients With Parkinson's Disease
Official title: Improvement In Gait Performance After Training Based On Declarative Memory Cues In Patients With Parkinson's Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Gait
cues
memory
training
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 50
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: Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute to progressive impairment in gait performance. The use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control. The purpose of this study is to verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (DLA) in patients with PD.

Detailed description: Background: Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute to progressive impairment in gait performance. The use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control.

Objectives: To verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (DLA) in patients with PD.

Design: Parallel prospective, single blind, randomized clinical trial. Setting: Brazilian Parkinson Association. Participants: Forty-four patients with PD in stages 2-3 of disease evolution according to Hoehn and Yahr Classification Interventions: The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS). The control training (CT) consisted of a similar gait training without DMCS.

Primary outcome measure: Gait performance in terms of speed and stride length. Secondary outcome measure: Independence in DLA according to Section II of the Unified Parkinson's Disease Rating Scale.

Randomization: Participants were randomized into a control group (CG), which performed the CT, and an experimental group (EG), which performed the ET, through blinded drawing of names.

Statistical analysis: The gait performance and ADL independence before, 2 and 60 days after the end of training were compared for CG and EG using Repeated-measures analysis of variance (RM-ANOVA).

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease according to the UK 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 ambulate independently indoors without aid;
* referring 5 to 15 years of education;
* good visual and auditory acuity.

Exclusion Criteria:

* presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
* visual and auditory deficiency;
* dementia \[assessed by the Mini Mental State Examination (MMSE), cut-off 23\];
* depression \[according to the Geriatric Depression Scale (GDS-15), cut-off 6\]
* participation in other physical therapy training.

Primary outcomes:
measure: gait speed
timeFrame: up to 3 months
measure: stride length on gait
timeFrame: up to 3 months
Secondary outcomes:
measure: Independence in activities of daily living (ADL)
timeFrame: up to 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Study officials:
affiliation: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
name: Maria Elisa P Piemonte, PhD
role: PRINCIPAL_INVESTIGATOR
References: