Parkinson's DiseaseNCT04494906
Interactive Stepping Exercise on Balance and Cognitive Function
A study testing Interactive stepping exercise and Square stepping exercise in people with Parkinson's Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with PD. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Interactive stepping exercise and Square stepping exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2020to 31 Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD
- Hoehn \& Yahr stage between 1 to 3
- Age between 50 to 85
- Stable pharmacologic treatment for the last 2 weeks
- Ability to walk 10 meters unassisted or with assistive devices
Who cannot join
- Other neurological disorders diagnosis than PD
- Receiving any neurological surgeries
- Any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study
- The Mini-Mental State Examination (MMSE) < 24 scores
- Participated in other exercise intervention of study in the past 3 months
- Colorblindness or color vision deficiency
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei
Yea-Ru Yang, PhD, 886-2-28267279, yryang@ym.edu.tw
About this study
Official title: Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson's Disease
The objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with PD.
- Conditions
- Parkinson's Disease
- Being tested
- Interactive stepping exercise, Square stepping exercise
- Keywords
- Interactive stepping exercise, Square stepping exercise, Parkinson's disease, Balance ability, Cognitive function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive stepping exerciseOther
An exercise intervention based on the principle of square stepping exercise
Square stepping exerciseOther
Square stepping exercise
| Study group | Role | What they receive |
|---|---|---|
| Interactive stepping exercise group | Experimental | Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions). Receives: Other: Interactive stepping exercise |
| Square stepping exercise group | Active comparator | Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions). Receives: Other: Square stepping exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Romberg test
To evaluate static balance ability
Measured: Change from baseline at 8 weeks and 12 weeks
Sharpened Romberg test
To evaluate static balance ability
Measured: Change from baseline at 8 weeks and 12 weeks
One-leg stance test
To evaluate static balance ability
Measured: Change from baseline at 8 weeks and 12 weeks
Timed up and go test
To evaluate functional walking ability
Measured: Change from baseline at 8 weeks and 12 weeks
Mini-Balance Evaluation Systems Test
To evaluate balance ability
Measured: Change from baseline at 8 weeks and 12 weeks
Montreal Cognitive Assessment Chinese version
To evaluate global cognitive function
Measured: Change from baseline at 8 weeks and 12 weeks
Digit span test
To evaluate executive function
Measured: Change from baseline at 8 weeks and 12 weeks
Stroop color and word test Chinese version
To evaluate executive function
Measured: Change from baseline at 8 weeks and 12 weeks
Trail-making test Chinese version
To evaluate executive function
Measured: Change from baseline at 8 weeks and 12 weeks
Spatial span test
To evaluate visuospatial ability
Measured: Change from baseline at 8 weeks and 12 weeks
Secondary outcomes (2)
10-meter walk test
To evaluate walking ability
Measured: Change from baseline at 8 weeks and 12 weeks
Parkinson's Disease Questionnaire 39
To evaluate the quality of life
Measured: Change from baseline at 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start19 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494906
- Sponsor's protocol ID
- YM109104F
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 27 Aug 2020
- 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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04494906
- Acronym / sponsor ID
- YM109104F
- Conditions
- Parkinson's Disease
- Keywords
- Interactive stepping exercise, Square stepping exercise, Parkinson's disease, Balance ability, Cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Jul 2020 (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 objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive stepping exercise group | Experimental | Other: Interactive stepping exerciseParticipants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions). |
| Square stepping exercise group | Active comparator | Other: Square stepping exerciseParticipants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic PD
- Hoehn \& Yahr stage between 1 to 3
- Age between 50 to 85
- Stable pharmacologic treatment for the last 2 weeks
- Ability to walk 10 meters unassisted or with assistive devices
Key exclusion criteria (6 listed)
- Other neurological disorders diagnosis than PD
- Receiving any neurological surgeries
- Any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study
- The Mini-Mental State Examination (MMSE) < 24 scores
- Participated in other exercise intervention of study in the past 3 months
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 |
|---|---|---|
| Interactive stepping exerciseAn exercise intervention based on the principle of square stepping exercise | Other | Interactive stepping exercise group |
| Square stepping exerciseSquare stepping exercise | Other | Square stepping exercise group |
Primary outcome
Romberg test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate static balance ability
Sharpened Romberg test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate static balance ability
One-leg stance test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate static balance ability
Timed up and go test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate functional walking ability
Mini-Balance Evaluation Systems Test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate balance ability
Montreal Cognitive Assessment Chinese version
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate global cognitive function
Digit span test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate executive function
Stroop color and word test Chinese version
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate executive function
Trail-making test Chinese version
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate executive function
Spatial span test
Time frame: Change from baseline at 8 weeks and 12 weeks
To evaluate visuospatial ability
2 secondary outcomes
10-meter walk test
Time frame: Change from baseline at 8 weeks and 12 weeks
Parkinson's Disease Questionnaire 39
Time frame: Change from baseline at 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive stepping exercise and Square stepping exercise in people with Parkinson's 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 6 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 27 Aug 2020. 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 Yea-Ru Yang, PhD (+886-2-28267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Romberg test (time frame: Change from baseline at 8 weeks and 12 weeks). The study lists 10 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 27 Aug 2020.