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

Primary Purpose

Parkinson Disease(PD)

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Weight shift training and APA feedback
Weight shift training without APA feedback
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease(PD) focused on measuring Gait Initiation, Freezing of gait, Balance training, Anticipatory postural adjustments

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chang Gung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Experimental

No Intervention

Arm Label

Stage 1:Healthy people

Stage 2:Healthy people

Stage 2:PD people

Stage 3:PD APA training group

Stage 3:PD Balance training group

Stage 3:PD Control group

Arm Description

To establish baseline and reliability.

To establish stage 3 training protocol.

To establish stage 3 training protocol.

Weight shift training and APA feedback.

Weight shift training without APA feedback.

Control group

Outcomes

Primary Outcome Measures

Gait parameters
Measure of changes in gait parameters by GaitRite and force plate.
Balance parameters
Measure of changes in balance parameters by force plate.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2016
Last Updated
January 13, 2016
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT02656355
Brief Title
Gait Initiation Difficulty and Anticipatory Postural Adjustment (APA) Impairment in People With PD - Evaluation and Training
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease(PD)
Keywords
Gait Initiation, Freezing of gait, Balance training, Anticipatory postural adjustments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1:Healthy people
Arm Type
No Intervention
Arm Description
To establish baseline and reliability.
Arm Title
Stage 2:Healthy people
Arm Type
No Intervention
Arm Description
To establish stage 3 training protocol.
Arm Title
Stage 2:PD people
Arm Type
No Intervention
Arm Description
To establish stage 3 training protocol.
Arm Title
Stage 3:PD APA training group
Arm Type
Experimental
Arm Description
Weight shift training and APA feedback.
Arm Title
Stage 3:PD Balance training group
Arm Type
Experimental
Arm Description
Weight shift training without APA feedback.
Arm Title
Stage 3:PD Control group
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Weight shift training and APA feedback
Other Intervention Name(s)
APA training group
Intervention Description
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Intervention Type
Other
Intervention Name(s)
Weight shift training without APA feedback
Other Intervention Name(s)
Balance training group
Intervention Description
Use COP trajectory to train weight shift on force plate.
Primary Outcome Measure Information:
Title
Gait parameters
Description
Measure of changes in gait parameters by GaitRite and force plate.
Time Frame
Baseline, 4 weeks and 8 weeks.
Title
Balance parameters
Description
Measure of changes in balance parameters by force plate.
Time Frame
Baseline, 4 weeks and 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Ju Chang, PhD
Phone
88632118800
Ext
5515
Email
yjchang@mail.cgu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

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