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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02656355
Other study ID # 103-5361B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2015
Est. completion date January 31, 2019

Study information

Verified date March 2024
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 31, 2019
Est. primary completion date October 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Weight shift training without APA feedback
Use COP trajectory to train weight shift on force plate.

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait parameters Measure of changes in gait parameters by GaitRite and force plate. Baseline, 4 weeks and 8 weeks.
Primary Balance parameters Measure of changes in balance parameters by force plate. Baseline, 4 weeks and 8 weeks.
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