Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait

July 25, 2023 updated by: Ray-Yau Wang, National Yang Ming University
The purpose of this single-blinded, randomized controlled study aims to establish the effects of functional postural control training on functional performance and FOG in PD individuals with FoG as compared with treadmill training.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and purpose: Freezing of gait (FoG), is a common sign in patients with Parkinson's disease (PD), especially at the advanced stage. Advanced functional activities, such as dual task walking, turning, or crossing a door often induce the FOG. FoG is a complex phenomenon which pathophysiology is currently unknown. However, previous studies have found that postural instability may be a risk factor for FoG. In addition, previous studies have suggested the interactions between FoG and postural instability. Treadmill training has been shown to be relatively more effective to improve FoG than other interventions. On the other hand, postural control training was demonstrated to improve the severity of FoG and postural control in freezers. However, no study has investigated the effectiveness of functional postural control training on functional performance and FOG. Therefore, this study aims to establish the effects of functional postural control training on functional performance and FOG in PD individuals with FoG as compared with treadmill training.

Methods: This study is a single-blinded randomized controlled trial. Twenty PD people with FoG will be recruited and randomized to the experimental and control group. The experimental group will receive functional postural control training, and the control group will receive treadmill training. Each intervention is 30 minutes/ session, 3 sessions/ weeks, for 4 weeks. The primary outcome is functional performance, which will measure the walking speed, cadence, and step length in the four conditions, including (1) Time up and go test, (2) Dual task Time up and go test, (3) 360º turning in place, and (4) Walking through the door. The secondary outcome is the severity of FoG which is assessed by the New Freezing of Gait Questionnaire (NFOGQ). All outcomes will be assessed before and after the training program. Demographic data at baseline will be analyzed by using Chi-square test or independent T-test. Two-way repeated ANOVA will be performed to analyze the primary and secondary outcomes. The significance level is set at p<0.05.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang Ming Chiao Tung 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hoehn and Yahr stage 2~4
  • Age between 50 to 80 years
  • New Freezing of Gait Questionnaire score > 1
  • Able to walk independently for at least 10 meters
  • MMSE score ≥24

Exclusion Criteria:

  • Neurological diseases other than PD
  • Any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional postural control training
The training includes (1) Maintaining a stationary posture in a standing position for a total of 10 minutes, (2) Posture control training involving unilateral lower limb stepping movements for a total of 10 minutes, and (3) Advanced walking task training, including sudden stops, turns, ball raises, and obstacle crossing during walking, for a total of 10 minutes.
Other: Functional postural control training
All participants will receive functional postural control training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).
Active Comparator: Treadmill training
The subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed.
Other: Treadmill training
All participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional performance-Time up and go test-speed(m/s)
Time Frame: Change from baseline time up and go test walking speed and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate walking speed during the Time Up and Go test.
Change from baseline time up and go test walking speed and up to 4 weeks (pre- and post-test)
Functional performance-Time up and go test-cadence (steps/ min)
Time Frame: Change from baseline time up and go test cadence and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate cadence during the Time Up and Go test.
Change from baseline time up and go test cadence and up to 4 weeks (pre- and post-test)
Functional performance-Time up and go test-step length (m)
Time Frame: Change from baseline time up and go test step length and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate step length during the Time Up and Go test.
Change from baseline time up and go test step length and up to 4 weeks (pre- and post-test)
Functional performance-dual task Time up and go test-speed(m/s)
Time Frame: Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate walking speed during the dual task Time up and go test.
Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)
Functional performance-dual task Time up and go test-cadence (steps/ min)
Time Frame: Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate cadence during the dual task Time up and go test.
Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)
Functional performance-dual task Time up and go test-step length (m)
Time Frame: Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate step length during the dual task Time up and go test.
Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)
Functional performance-360º turning in place-speed(m/s)
Time Frame: Change from baseline 360º turning in place speed and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate speed during the 360º turning in place test.
Change from baseline 360º turning in place speed and up to 4 weeks (pre- and post-test)
Functional performance-360º turning in place-cadence (steps/ min)
Time Frame: Change from baseline 360º turning in place cadence and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate cadence during the 360º turning in place test.
Change from baseline 360º turning in place cadence and up to 4 weeks (pre- and post-test)
Functional performance-360º turning in place-step length (m)
Time Frame: Change from baseline 360º turning in place step length and up to 4 weeks (pre- and post-test)
Using GaitUp system to evaluate step length during the 360º turning in place test.
Change from baseline 360º turning in place step length and up to 4 weeks (pre- and post-test)
Functional performance-Walking through the door-speed(m/s)
Time Frame: Change from baseline walking through the door speed and up to 4 weeks (pre- and post-test)
Using GAITRite® system to evaluate walking speed during walks through the door.
Change from baseline walking through the door speed and up to 4 weeks (pre- and post-test)
Functional performance-Walking through the door-cadence (steps/ min)
Time Frame: Change from baseline walking through the door cadence and up to 4 weeks (pre- and post-test)
Using GAITRite® system to evaluate cadence during walks through the door.
Change from baseline walking through the door cadence and up to 4 weeks (pre- and post-test)
Functional performance-Walking through the door-step length (m)
Time Frame: Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)
Using GAITRite® system to evaluate step length during walks through the door.
Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Freezing of Gait Questionnaire (NFOGQ)
Time Frame: Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)

Use the New Freezing of Gait Questionnaire (NFOGQ)-Chinese version to assess the severity of freezing of gait.

The score ranged from 0 to 29. Higher scores show increased severity in freezing of gait.
Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)

Collaborators and Investigators

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

Sponsor

National Yang Ming University

Investigators

  • Principal Investigator: Ray-Yau Wang, PhD, National Yang Ming Chiao Tung 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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYCU112071AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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