NCT02671396

Brief Summary

The present study is to examine the effects of a virtual reality based balance training using the Kinect sensor on postural stability and functional balance in individuals with Parkinson's disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 26, 2016

Last Update Submit

January 28, 2016

Conditions

Parkinson's Disease

Keywords

Virtual RealityPostural StabilityBalance TrainingParkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • Limits of stability test

    Change from Baseline at 8 weeks

  • One-leg stance test

    Change from Baseline at 8 weeks

Secondary Outcomes (2)

  • Berg Balance Scale

    Change from Baseline at 8 weeks

  • Timed up and go test

    Change from Baseline at 8 weeks

Study Arms (2)

Virtual reality based intervention

EXPERIMENTAL

Virtual reality based balance training

Behavioral: Virtual reality based intervention

Conventional intervention

ACTIVE COMPARATOR

Conventional balance training

Behavioral: Conventional intervention

Interventions

Virtual reality based interventionBEHAVIORAL

Virtual reality based balance training

Virtual reality based intervention
Conventional interventionBEHAVIORAL

Conventional balance training

Conventional intervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hoehn and Yahr stages I through III
  • A score of more than or equal to 24 on the mini-mental state examination
  • Stable medication usage
  • Freedom from any other problems that might affect training

You may not qualify if:

  • Unstable medical conditions
  • Histories of other diseases known to interfere with participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shih MC, Wang RY, Cheng SJ, Yang YR. Effects of a balance-based exergaming intervention using the Kinect sensor on posture stability in individuals with Parkinson's disease: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2016 Aug 27;13(1):78. doi: 10.1186/s12984-016-0185-y.

    PMID: 27568011DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 2, 2016

Record last verified: 2016-01