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

March 26, 2024 updated by: Ya-Ju Chang, Chang Gung University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Balance training group
No Intervention: Stage 3:PD Control group
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait parameters
Time Frame: Baseline, 4 weeks and 8 weeks.
Measure of changes in gait parameters by GaitRite and force plate.
Baseline, 4 weeks and 8 weeks.
Balance parameters
Time Frame: Baseline, 4 weeks and 8 weeks.
Measure of changes in balance parameters by force plate.
Baseline, 4 weeks and 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2015

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimated)

January 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-5361B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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