search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Functional postural control training
Treadmill training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing of gait, Functional postural control training, Functional performance, Parkinson's disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang Ming Chiao Tung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional postural control training

Treadmill training

Arm Description

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.

The subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed.

Outcomes

Primary Outcome Measures

Functional performance-Time up and go test-speed(m/s)
Using GaitUp system to evaluate walking speed during the Time Up and Go test.
Functional performance-Time up and go test-cadence (steps/ min)
Using GaitUp system to evaluate cadence during the Time Up and Go test.
Functional performance-Time up and go test-step length (m)
Using GaitUp system to evaluate step length during the Time Up and Go test.
Functional performance-dual task Time up and go test-speed(m/s)
Using GaitUp system to evaluate walking speed during the dual task Time up and go test.
Functional performance-dual task Time up and go test-cadence (steps/ min)
Using GaitUp system to evaluate cadence during the dual task Time up and go test.
Functional performance-dual task Time up and go test-step length (m)
Using GaitUp system to evaluate step length during the dual task Time up and go test.
Functional performance-360º turning in place-speed(m/s)
Using GaitUp system to evaluate speed during the 360º turning in place test.
Functional performance-360º turning in place-cadence (steps/ min)
Using GaitUp system to evaluate cadence during the 360º turning in place test.
Functional performance-360º turning in place-step length (m)
Using GaitUp system to evaluate step length during the 360º turning in place test.
Functional performance-Walking through the door-speed(m/s)
Using GAITRite® system to evaluate walking speed during walks through the door.
Functional performance-Walking through the door-cadence (steps/ min)
Using GAITRite® system to evaluate cadence during walks through the door.
Functional performance-Walking through the door-step length (m)
Using GAITRite® system to evaluate step length during walks through the door.

Secondary Outcome Measures

New Freezing of Gait Questionnaire (NFOGQ)
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.

Full Information

First Posted
July 14, 2023
Last Updated
July 25, 2023
Sponsor
National Yang Ming University
search

1. Study Identification

Unique Protocol Identification Number
NCT05958355
Brief Title
Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait
Official Title
Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Freezing of gait, Functional postural control training, Functional performance, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional postural control training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill training
Arm Type
Active Comparator
Arm Description
The subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed.
Intervention Type
Other
Intervention Name(s)
Functional postural control training
Intervention Description
All participants will receive functional postural control training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
All participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).
Primary Outcome Measure Information:
Title
Functional performance-Time up and go test-speed(m/s)
Description
Using GaitUp system to evaluate walking speed during the Time Up and Go test.
Time Frame
Change from baseline time up and go test walking speed and up to 4 weeks (pre- and post-test)
Title
Functional performance-Time up and go test-cadence (steps/ min)
Description
Using GaitUp system to evaluate cadence during the Time Up and Go test.
Time Frame
Change from baseline time up and go test cadence and up to 4 weeks (pre- and post-test)
Title
Functional performance-Time up and go test-step length (m)
Description
Using GaitUp system to evaluate step length during the Time Up and Go test.
Time Frame
Change from baseline time up and go test step length and up to 4 weeks (pre- and post-test)
Title
Functional performance-dual task Time up and go test-speed(m/s)
Description
Using GaitUp system to evaluate walking speed during the dual task Time up and go test.
Time Frame
Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)
Title
Functional performance-dual task Time up and go test-cadence (steps/ min)
Description
Using GaitUp system to evaluate cadence during the dual task Time up and go test.
Time Frame
Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)
Title
Functional performance-dual task Time up and go test-step length (m)
Description
Using GaitUp system to evaluate step length during the dual task Time up and go test.
Time Frame
Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)
Title
Functional performance-360º turning in place-speed(m/s)
Description
Using GaitUp system to evaluate speed during the 360º turning in place test.
Time Frame
Change from baseline 360º turning in place speed and up to 4 weeks (pre- and post-test)
Title
Functional performance-360º turning in place-cadence (steps/ min)
Description
Using GaitUp system to evaluate cadence during the 360º turning in place test.
Time Frame
Change from baseline 360º turning in place cadence and up to 4 weeks (pre- and post-test)
Title
Functional performance-360º turning in place-step length (m)
Description
Using GaitUp system to evaluate step length during the 360º turning in place test.
Time Frame
Change from baseline 360º turning in place step length and up to 4 weeks (pre- and post-test)
Title
Functional performance-Walking through the door-speed(m/s)
Description
Using GAITRite® system to evaluate walking speed during walks through the door.
Time Frame
Change from baseline walking through the door speed and up to 4 weeks (pre- and post-test)
Title
Functional performance-Walking through the door-cadence (steps/ min)
Description
Using GAITRite® system to evaluate cadence during walks through the door.
Time Frame
Change from baseline walking through the door cadence and up to 4 weeks (pre- and post-test)
Title
Functional performance-Walking through the door-step length (m)
Description
Using GAITRite® system to evaluate step length during walks through the door.
Time Frame
Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)
Secondary Outcome Measure Information:
Title
New Freezing of Gait Questionnaire (NFOGQ)
Description
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.
Time Frame
Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray-Yau Wang, PhD
Phone
+886-2-2826-7210
Email
rywang@nycu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, PhD
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs