NCT02118506

Brief Summary

The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable parkinson-disease

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

December 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

January 20, 2014

Last Update Submit

April 16, 2014

Conditions

Keywords

Primary Parkinsonism.Rehabilitation.Biomechanics.Neurological gait disorders.

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Step length at 10 minutes and 1 day

    Three observetions were done. At baseline, 10 minutes and 1 day after intervention.

Secondary Outcomes (1)

  • Change from Baseline in Double Limb Support Time at 10 minutes and 1 day

    Three observetions were done. At baseline, 10 minutes and 1 day after intervention.

Study Arms (2)

Physical practice

ACTIVE COMPARATOR

Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Physical practice: is the execution of the motor action.

Other: Physical practice

Mental and physical practice

EXPERIMENTAL

Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Mental practice: is defined as motor imagery training with the aim of improving the engine performance. Is the imagination of a motor action without its physical implementation. Physical practice: is the execution of the motor action.

Other: Mental and physical practice

Interventions

The control group underwent familiarization of gait phases using cards with gait phases and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.

Physical practice

The experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases. Finally, they were submitted to a physical gait training. They executed 400 steps. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.

Mental and physical practice

Eligibility Criteria

Age44 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the subjects should be in use of antiparkinsonian medication,
  • be between stages 2 and 3 of the Hoehn and Yahr modified scale);
  • walk without any brace or aid device, independently (scores between 3 and 5 of the Functional Ambulatory Category - FAC) for at least 10 meters
  • were not undergoing stereotactic surgery.

You may not qualify if:

  • We excluded those who were unable or declined to complete the training protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59078-970, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lorenna M. de Melo Santiago, Master

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Ana Raquel Rodrigues Lindquist

Study Record Dates

First Submitted

January 20, 2014

First Posted

April 21, 2014

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations