Parkinson DiseaseNCT05958355
Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait
A study testing Treadmill training in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological diseases other than PD
- Any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Functional postural control training, Treadmill training
- Keywords
- Freezing of gait, Functional postural control training, Functional performance, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional postural control trainingOther
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 trainingOther
All participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).
| Study group | Role | What they receive |
|---|---|---|
| Functional postural control training | Experimental | 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. Receives: Other: Functional postural control training |
| Treadmill training | Active comparator | The subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed. Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance-Time up and go test-speed(m/s)
Using GaitUp system to evaluate walking speed during the Time Up and Go test.
Measured: 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)
Using GaitUp system to evaluate cadence during the Time Up and Go test.
Measured: 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)
Using GaitUp system to evaluate step length during the Time Up and Go test.
Measured: 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)
Using GaitUp system to evaluate walking speed during the dual task Time up and go test.
Measured: 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)
Using GaitUp system to evaluate cadence during the dual task Time up and go test.
Measured: 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)
Using GaitUp system to evaluate step length during the dual task Time up and go test.
Measured: 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)
Using GaitUp system to evaluate speed during the 360º turning in place test.
Measured: 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)
Using GaitUp system to evaluate cadence during the 360º turning in place test.
Measured: 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)
Using GaitUp system to evaluate step length during the 360º turning in place test.
Measured: 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)
Using GAITRite® system to evaluate walking speed during walks through the door.
Measured: 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)
Using GAITRite® system to evaluate cadence during walks through the door.
Measured: 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)
Using GAITRite® system to evaluate step length during walks through the door.
Measured: Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)
Secondary outcomes (1)
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.
Measured: Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray-Yau Wang, National Yang Ming Chiao Tung University
- Investigators
- Ray-Yau Wang, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958355
- Sponsor's protocol ID
- NYCU112071AF
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait
- ClinicalTrials.gov ID
- NCT05958355
- Acronym / sponsor ID
- NYCU112071AF
- Conditions
- Parkinson Disease
- Keywords
- Freezing of gait, Functional postural control training, Functional performance, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional postural control training | Experimental | Other: Functional postural control trainingThe 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. |
| Treadmill training | Active comparator | Other: Treadmill trainingThe subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Neurological diseases other than PD
- Any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional postural control trainingAll participants will receive functional postural control training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions). | Other | Functional postural control training |
| Treadmill trainingAll participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions). | Other | Treadmill training |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray-Yau Wang, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ray-Yau Wang, PhD (+886-2-2826-7210, rywang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.