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Multisensory Training in PD

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Multisensory training

Conventional training

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Multisensory training, Gait variability

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multisensory training group

Conventional training group.

Arm Description

The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks

Outcomes

Primary Outcome Measures

Gait variability

Using GAITRite system to measure coefficient of variation

Secondary Outcome Measures

Gait performance

Using the GAITRite system to evaluate saptiotemporal parameters

Sensory organization test

Using NeuroCom Smart Balance Master

Timed up and go test

To evaluate functional mobility

Dynamic Gait Index

To evaluate functional mobility

Full Information

NCT ID

NCT05027555

First Posted

August 21, 2021

Last Updated

August 26, 2021

Sponsor

National Yang Ming University

1. Study Identification

Unique Protocol Identification Number

NCT05027555

Brief Title

Multisensory Training in PD

Official Title

Effect of Multisensory Training on Gait Variability in People With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Multisensory training, Gait variability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multisensory training group

Arm Type

Experimental

Arm Description

The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks

Arm Title

Conventional training group.

Arm Type

Active Comparator

Arm Description

The intervention is a 50-minute session and 2-sessions/week, totaling 6 weeks

Intervention Type

Other

Intervention Name(s)

Multisensory training

Intervention Description

Multisensory training included marching on the foam with visual deprivation and treadmill training with visual deprivation

Intervention Type

Other

Intervention Name(s)

Conventional training

Intervention Description

Conventional training included strengthening, balance training and gait training

Primary Outcome Measure Information:

Title

Gait variability

Description

Using GAITRite system to measure coefficient of variation

Time Frame

Change from baseline at 6 weeks

Secondary Outcome Measure Information:

Title

Gait performance

Description

Using the GAITRite system to evaluate saptiotemporal parameters

Time Frame

Change from baseline at 6 weeks

Title

Sensory organization test

Description

Using NeuroCom Smart Balance Master

Time Frame

Change from baseline at 6 weeks

Title

Timed up and go test

Description

To evaluate functional mobility

Time Frame

Change from baseline at 6 weeks

Title

Dynamic Gait Index

Description

To evaluate functional mobility

Time Frame

Change from baseline at 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Yea-Ru, PhD

Phone

+886228267279

yryang@nycu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Multisensory Training in PD

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