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Gait Initiation Difficulty and Anticipatory Postural Adjustment (APA) Impairment in People With PD - Evaluation and Training

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ClinicalTrials.gov Identifier: NCT02656355
Recruitment Status : Unknown
Verified January 2016 by Ya-Ju Chang, Chang Gung University.
Recruitment status was:  Recruiting
First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Ya-Ju Chang, Chang Gung University

Brief Summary:

Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies showed that the GI difficulty was related to impaired anticipatory postural adjustments (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal multiple APAs were observed during GI.

Conventional balance tests record the maximum displacement and/or velocity of Center of pressure (COP). However, these variables could not show the performance of APA. Previous studies suggested that balance and gait initiation were controlled by separate neural circuitries. This could explain why the conventional COP measurement did not correlate to GI very well.

It is important to develop GI related APA tests and trainings. Researchers found that a perturbation applied before the COP displacement during GI could delay both GI and APA. This indicates that COP displacement has APA components. Our pilot study shows that there is a reverse direction of COP displacement before voluntary COP displacement, suggesting the existence of APA.

This three year project will evaluate the relationship of the APA of voluntary COP displacement and the APA of GI, establish the APA test for PD, and investigate the effect of APA training on GI in people with PD.

In the first year, 20 people without disability will be recruited. The APA before voluntary COP displacement test, APA before GI, and gait performance will be evaluated. In the second year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI test, gait test, and APA before voluntary COP displacement test. The relationship between different types of APA will be established for PD and healthy people. In the third year, 30 people with PD will be randomized into APA training group, balance group, and control group. The different training effect will be evaluated especially on GI, gait performance, and freezing of gait.

This project will advance the knowledge of mechanism of GI difficulty. The result of this project can be applied to clinical rehabilitation of people with GI difficulty.


Condition or disease Intervention/treatment Phase
Parkinson Disease(PD) Other: Weight shift training and APA feedback Other: Weight shift training without APA feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Stage 1:Healthy people
To establish baseline and reliability.
No Intervention: Stage 2:Healthy people
To establish stage 3 training protocol.
No Intervention: Stage 2:PD people
To establish stage 3 training protocol.
Experimental: Stage 3:PD APA training group
Weight shift training and APA feedback.
Other: Weight shift training and APA feedback
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Other Name: APA training group

Experimental: Stage 3:PD Balance training group
Weight shift training without APA feedback.
Other: Weight shift training without APA feedback
Use COP trajectory to train weight shift on force plate.
Other Name: Balance training group

No Intervention: Stage 3:PD Control group
Control group



Primary Outcome Measures :
  1. Gait parameters [ Time Frame: Baseline, 4 weeks and 8 weeks. ]
    Measure of changes in gait parameters by GaitRite and force plate.

  2. Balance parameters [ Time Frame: Baseline, 4 weeks and 8 weeks. ]
    Measure of changes in balance parameters by force plate.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Health subjects:

Exclusion Criteria:

  • Musculoskeletal injuries on legs.
  • Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656355


Locations
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Taiwan
Chang Gung University Recruiting
Taoyuan, Taiwan, 333
Contact: Ya-Ju Chang, PhD    88632118800 ext 5515    yjchang@mail.cgu.edu.tw   
Sponsors and Collaborators
Chang Gung University

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Responsible Party: Ya-Ju Chang, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02656355     History of Changes
Other Study ID Numbers: 103-5361B
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Ya-Ju Chang, Chang Gung University:
Gait Initiation
Freezing of gait
Balance training
Anticipatory postural adjustments

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases