NCT02600728

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

November 4, 2015

Last Update Submit

November 6, 2015

Conditions

Keywords

Parkinson DiseaseGaitcuesmemorytraining

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)

EXPERIMENTAL

The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).

Behavioral: Experimental Training

control group (CG)

ACTIVE COMPARATOR

The control training (CT) consisted of a similar gait training without DMCS.

Behavioral: Control Training

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.

Also known as: Declarative memory cues strategy (DMCS)
experimental group (EG)

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.

control group (CG)

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Maria Elisa P Piemonte, PhD

    Department of Physiotherapy, 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
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

Locations