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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental Training
Control Training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Gait, cues, memory, training

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group (EG)

control group (CG)

Arm Description

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.

Outcomes

Primary Outcome Measures

gait speed
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.
stride length on gait
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.

Secondary Outcome Measures

Independence in activities of daily living (ADL)
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.

Full Information

First Posted
November 4, 2015
Last Updated
November 6, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02600728
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Gait, cues, memory, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (EG)
Arm Type
Experimental
Arm Description
The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).
Arm Title
control group (CG)
Arm Type
Active Comparator
Arm Description
The control training (CT) consisted of a similar gait training without DMCS.
Intervention Type
Behavioral
Intervention Name(s)
Experimental Training
Other Intervention Name(s)
Declarative memory cues strategy (DMCS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
gait speed
Description
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.
Time Frame
up to 3 months
Title
stride length on gait
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Independence in activities of daily living (ADL)
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte, PhD
Organizational Affiliation
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

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

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