Clinical trial NCT05958355: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of gait
Functional postural control training
Functional performance
Parkinson's disease
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional performance-Time up and go test-speed(m/s)
timeFrame: Change from baseline time up and go test walking speed and up to 4 weeks (pre- and post-test)
measure: Functional performance-Time up and go test-cadence (steps/ min)
timeFrame: Change from baseline time up and go test cadence and up to 4 weeks (pre- and post-test)
measure: Functional performance-Time up and go test-step length (m)
timeFrame: Change from baseline time up and go test step length and up to 4 weeks (pre- and post-test)
measure: Functional performance-dual task Time up and go test-speed(m/s)
timeFrame: Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)
measure: Functional performance-dual task Time up and go test-cadence (steps/ min)
timeFrame: Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)
measure: Functional performance-dual task Time up and go test-step length (m)
timeFrame: Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)
measure: Functional performance-360º turning in place-speed(m/s)
timeFrame: Change from baseline 360º turning in place speed and up to 4 weeks (pre- and post-test)
measure: Functional performance-360º turning in place-cadence (steps/ min)
timeFrame: Change from baseline 360º turning in place cadence and up to 4 weeks (pre- and post-test)
measure: Functional performance-360º turning in place-step length (m)
timeFrame: Change from baseline 360º turning in place step length and up to 4 weeks (pre- and post-test)
measure: Functional performance-Walking through the door-speed(m/s)
timeFrame: Change from baseline walking through the door speed and up to 4 weeks (pre- and post-test)
measure: Functional performance-Walking through the door-cadence (steps/ min)
timeFrame: Change from baseline walking through the door cadence and up to 4 weeks (pre- and post-test)
measure: Functional performance-Walking through the door-step length (m)
timeFrame: Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)
Secondary outcomes:
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: