NCT05027555

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 21, 2021

Last Update Submit

August 26, 2021

Conditions

Keywords

Multisensory trainingGait variability

Outcome Measures

Primary Outcomes (1)

  • Gait variability

    Using GAITRite system to measure coefficient of variation

    Change from baseline at 6 weeks

Secondary Outcomes (4)

  • Gait performance

    Change from baseline at 6 weeks

  • Sensory organization test

    Change from baseline at 6 weeks

  • Timed up and go test

    Change from baseline at 6 weeks

  • Dynamic Gait Index

    Change from baseline at 6 weeks

Study Arms (2)

Multisensory training group

EXPERIMENTAL

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

Other: Multisensory training

Conventional training group.

ACTIVE COMPARATOR

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

Other: Conventional training

Interventions

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

Multisensory training group

Conventional training included strengthening, balance training and gait training

Conventional training group.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Affecting the peripheral vestibular system
  • Medical condition that substantially influenced their gait and balance performance
  • People had joined any rehabilitation past 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Yang Yea-Ru, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2021

First Posted

August 30, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08