NCT02656355

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

January 13, 2016

Last Update Submit

March 26, 2024

Conditions

Keywords

Gait InitiationFreezing of gaitBalance trainingAnticipatory postural adjustments

Outcome Measures

Primary Outcomes (2)

  • Gait parameters

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

    Baseline, 4 weeks and 8 weeks.

  • Balance parameters

    Measure of changes in balance parameters by force plate.

    Baseline, 4 weeks and 8 weeks.

Study Arms (6)

Stage 1:Healthy people

NO INTERVENTION

To establish baseline and reliability.

Stage 2:Healthy people

NO INTERVENTION

To establish stage 3 training protocol.

Stage 2:PD people

NO INTERVENTION

To establish stage 3 training protocol.

Stage 3:PD APA training group

EXPERIMENTAL

Weight shift training and APA feedback.

Other: Weight shift training and APA feedback

Stage 3:PD Balance training group

EXPERIMENTAL

Weight shift training without APA feedback.

Other: Weight shift training without APA feedback

Stage 3:PD Control group

NO INTERVENTION

Control group

Interventions

Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.

Also known as: APA training group
Stage 3:PD APA training group

Use COP trajectory to train weight shift on force plate.

Also known as: Balance training group
Stage 3:PD Balance training group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Musculoskeletal injuries on legs.
  • Osteoporosis.
  • PD subjects:
  • \- Clinical diagnosis of Parkinson disease.
  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 14, 2016

Study Start

May 11, 2015

Primary Completion

October 30, 2018

Study Completion

January 31, 2019

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations