Training Based On Declarative Memory Cues Improved Gait In Patients With Parkinson's Disease
Improvement In Gait Performance After Training Based On Declarative Memory Cues In Patients With Parkinson's Disease: A Randomized Clinical Trial
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedNovember 9, 2015
November 1, 2015
1.4 years
November 4, 2015
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
up to 3 months
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.
up to 3 months
Secondary Outcomes (1)
Independence in activities of daily living (ADL)
up to 3 months
Study Arms (2)
experimental group (EG)
EXPERIMENTALThe experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).
control group (CG)
ACTIVE COMPARATORThe control training (CT) consisted of a similar gait training without DMCS.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
São Paulo, São Paulo, 05360-160, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Elisa P Piemonte, PhD
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 9, 2015
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
November 9, 2015
Record last verified: 2015-11