Training Based On Declarative Memory Cues Improved Gait In Patients With Parkinson's Disease

November 6, 2015 updated by: University of Sao Paulo General Hospital

Improvement In Gait Performance After Training Based On Declarative Memory Cues In Patients With Parkinson's Disease: A Randomized Clinical Trial

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 05360-160
        • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group (EG)
The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).

The ET consisted of 3 phases being that the first one (Phase 1) was done only in the first session.

Phase 1: patients received a short and simple explanation about the deficiency in automatic movement resulting from PD. Following explanation, the patient memorized a sequence of declarative cues. Phase 2: the patient organized a sequence of cues using cards illustrating the subcomponent movements (key movement) involved in taking steps.

Phase 3: the patient had to train using declarative cues as a gait performance aid through 8 sets follow the instruction "Walk in your ordinary speed. Use the key movements and going to saying each of them while you make them. The declarative cues had to be evoked verbally by the patients themselves, during gait, triggering the corresponding movement.

Other Names:
  • Declarative memory cues strategy (DMCS)
Active Comparator: control group (CG)
The control training (CT) consisted of a similar gait training without DMCS.

The CT consisted of 3 phases, being the first one (Phase 1) was done only in the first session of training, and the other two (Phase 2 and 3) were repeated at each of the 8 sessions.

Phase 1: Patients received a short and simple explanation about the deficiency in automatic movement resulting from PD.

Phase 2: Patients received a general verbal attentional instruction of "pay attention to your steps and try to walk as better as you can", before starting the walk.

Phase 3: motor training of gait, where the patient had to perform 8 sets, following the instruction "Walk in your ordinary speed, paying attention to your steps" in the identical trajectories of ET. Additional instructions or cues were not provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait speed
Time Frame: up to 3 months
The first primary outcome was the gait speed (m/s). Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop". The speed was calculated based on the time to walk 20 meters timed using a digital chronometer.
up to 3 months
stride length on gait
Time Frame: up to 3 months
The second primary outcome was the stride length (cm) on gait. Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop". The number of steps was measured using a pedometer.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independence in activities of daily living (ADL)
Time Frame: up to 3 months
The secondary outcome was independence in activities of daily living (ADL), assessed by Section II of the Unified Parkinson Disease Rating Scale (UPDRS-II). This section includes 12 questions (items 5 to 16) on patient's performance in ADL. Among these questions, two investigate gait performance (frequent fall due to freezing; inability to walk ), with scores ranging from zero (normal) to 4.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria Elisa P Piemonte, PhD, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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