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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05958355
• Other study ID #: NYCU112071AF
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: National Yang Ming University
• Contact: Ray-Yau Wang, PhD
• Phone: +886-2-2826-7210
• Email: rywang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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).
• Treadmill training
All participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional performance-Time up and go test-speed(m/s)	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)
Primary	Functional performance-Time up and go test-cadence (steps/ min)	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)
Primary	Functional performance-Time up and go test-step length (m)	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)
Primary	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.	Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)
Primary	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.	Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)
Primary	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.	Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)
Primary	Functional performance-360º turning in place-speed(m/s)	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)
Primary	Functional performance-360º turning in place-cadence (steps/ min)	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)
Primary	Functional performance-360º turning in place-step length (m)	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)
Primary	Functional performance-Walking through the door-speed(m/s)	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)
Primary	Functional performance-Walking through the door-cadence (steps/ min)	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)
Primary	Functional performance-Walking through the door-step length (m)	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	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.	Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)