- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027555
Multisensory Training in PD
August 26, 2021 updated by: Yea-Ru Yang, National Yang Ming University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yang Yea-Ru, PhD
- Phone Number: +886228267279
- Email: yryang@nycu.edu.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Affecting the peripheral vestibular system
- Medical condition that substantially influenced their gait and balance performance
- People had joined any rehabilitation past 1 month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multisensory training group
The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks
|
Multisensory training included marching on the foam with visual deprivation and treadmill training with visual deprivation
|
|
Active Comparator: Conventional training group.
The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks
|
Conventional training included strengthening, balance training and gait training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait variability
Time Frame: Change from baseline at 6 weeks
|
Using GAITRite system to measure coefficient of variation
|
Change from baseline at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait performance
Time Frame: Change from baseline at 6 weeks
|
Using the GAITRite system to evaluate saptiotemporal parameters
|
Change from baseline at 6 weeks
|
|
Sensory organization test
Time Frame: Change from baseline at 6 weeks
|
Using NeuroCom Smart Balance Master
|
Change from baseline at 6 weeks
|
|
Timed up and go test
Time Frame: Change from baseline at 6 weeks
|
To evaluate functional mobility
|
Change from baseline at 6 weeks
|
|
Dynamic Gait Index
Time Frame: Change from baseline at 6 weeks
|
To evaluate functional mobility
|
Change from baseline at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
August 21, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 26, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21MMHIS153e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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