Parkinson DiseaseNCT05027555
Multisensory Training in PD
A study testing Multisensory training and Conventional training in people with Parkinson Disease, run by National Yang Ming Chiao Tung University.
Trial summary
People with Parkinson's disease (PD) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. These motor symptoms might cause gait dysfunction. 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?
- Multisensory training and Conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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
- Idiopathic PD
- Hoehn and Yahr stage I to III
- Age 60~80 y/o
- Mini-Mental State Examination (MMSE) ≥24
- Ability to ambulate independently (with or without walking aid)
Who cannot join
- Affecting the peripheral vestibular system
- Medical condition that substantially influenced their gait and balance performance
- People had joined any rehabilitation past 1 month
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Multisensory Training on Gait Variability in People With Parkinson's Disease
People with Parkinson's disease (PD) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. These motor symptoms might cause gait dysfunction. Gait dysfunction represented a common sign of PD, including reduced gait velocity, reduced stride length, reduced arm swing, and increased gait variability. Poor postural control in people with PD might result to increase gait variability and then increase fall risk. Previous studies reported that proprioceptive-vestibular multisensory training improved postural stability in people with PD. However, no literature investigated the effects of proprioceptive-vestibular multisensory training on gait variability. Therefore, the purpose of this study is to examine the effect of proprioceptive-vestibular multisensory training on gait variability in people with PD.
- Conditions
- Parkinson Disease
- Being tested
- Multisensory training, Conventional training
- Keywords
- Multisensory training, Gait variability
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory trainingOther
Multisensory training included marching on the foam with visual deprivation and treadmill training with visual deprivation
Conventional trainingOther
Conventional training included strengthening, balance training and gait training
| Study group | Role | What they receive |
|---|---|---|
| Multisensory training group | Experimental | The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks Receives: Other: Multisensory training |
| Conventional training group. | Active comparator | The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks Receives: Other: Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait variability
Using GAITRite system to measure coefficient of variation
Measured: Change from baseline at 6 weeks
Secondary outcomes (4)
Gait performance
Using the GAITRite system to evaluate saptiotemporal parameters
Measured: Change from baseline at 6 weeks
Sensory organization test
Using NeuroCom Smart Balance Master
Measured: Change from baseline at 6 weeks
Timed up and go test
To evaluate functional mobility
Measured: Change from baseline at 6 weeks
Dynamic Gait Index
To evaluate functional mobility
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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.
- 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
- NCT05027555
- Sponsor's protocol ID
- 21MMHIS153e
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory Training on Gait Variability in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05027555
- Acronym / sponsor ID
- 21MMHIS153e
- Conditions
- Parkinson Disease
- Keywords
- Multisensory training, Gait variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Aug 2021 (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.
People with Parkinson's disease (PD) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. These motor symptoms might cause gait dysfunction. Gait dysfunction represented a common sign of PD, including reduced gait velocity, reduced stride length, reduced arm swing, and increased gait variability. Poor postural control in people with PD might result to increase gait variability and then increase fall risk. Previous studies reported that proprioceptive-vestibular multisensory training improved postural stability in people with PD. However, no literature investigated the effects of proprioceptive-vestibular multisensory training on gait variability. Therefore, the purpose of this study is to examine the effect of proprioceptive-vestibular multisensory training on gait variability in people 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 |
|---|---|---|
| Multisensory training group | Experimental | Other: Multisensory trainingThe intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks |
| Conventional training group. | Active comparator | Other: Conventional trainingThe intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic PD
- Hoehn and Yahr stage I to III
- Age 60~80 y/o
- Mini-Mental State Examination (MMSE) ≥24
- Ability to ambulate independently (with or without walking aid)
Key exclusion criteria (3 listed)
- Affecting the peripheral vestibular system
- Medical condition that substantially influenced their gait and balance performance
- People had joined any rehabilitation past 1 month
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 |
|---|---|---|
| Multisensory trainingMultisensory training included marching on the foam with visual deprivation and treadmill training with visual deprivation | Other | Multisensory training group |
| Conventional trainingConventional training included strengthening, balance training and gait training | Other | Conventional training group. |
Primary outcome
Gait variability
Time frame: Change from baseline at 6 weeks
Using GAITRite system to measure coefficient of variation
4 secondary outcomes
Gait performance
Time frame: Change from baseline at 6 weeks
Sensory organization test
Time frame: Change from baseline at 6 weeks
Timed up and go test
Time frame: Change from baseline at 6 weeks
Dynamic Gait Index
Time frame: Change from baseline at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory training and Conventional training in people with Parkinson Disease, run by National Yang Ming Chiao Tung University.
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 3 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Yang Yea-Ru, PhD (+886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait variability (time frame: Change from baseline at 6 weeks). 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 30 Aug 2021.