NCT01301651

Brief Summary

Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control. Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly. Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training. Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up. Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

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

November 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

October 17, 2011

Status Verified

February 1, 2011

Enrollment Period

7 months

First QC Date

February 18, 2011

Last Update Submit

October 13, 2011

Conditions

Keywords

Virtual RealityBalanceParkinson's diseaseDual Task

Outcome Measures

Primary Outcomes (1)

  • The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.

    6 weeks

Study Arms (3)

virtual reality balance training

EXPERIMENTAL

balance board training with virtual reality intervention

Behavioral: balance training

conventional balance training

EXPERIMENTAL

physical therapy conventional balance training

Behavioral: balance training

control group

NO INTERVENTION

No physical therapy

Interventions

30 minute each time, 2 times per week for 6 weeks.

Also known as: virtual reality
conventional balance trainingvirtual reality balance training

Eligibility Criteria

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

You may qualify if:

  • (1) idiopathic Parkinson's disease, (2) intact cognition (Mini-Mental State Examination; MMSE\>24), 22 (3) Hoehn and Yahr (H-Y) stage II-III diagnosed by neurologists, (4) not participated in any balance or gait training previously, (5) able to follow simple command and had no uncontrolled chronic condition.-

You may not qualify if:

  • (1) history of other neurological, cardiovascular and orthopedic diseases affecting postural stability, (2) on-off motor fluctuation and dyskinesia above grade 3 by the Unified Parkinson' Disease Scale (UPDRS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  • Yen CY, Lin KH, Hu MH, Wu RM, Lu TW, Lin CH. Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Phys Ther. 2011 Jun;91(6):862-74. doi: 10.2522/ptj.20100050. Epub 2011 Apr 7.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kwan-Hwa Lin, PhD

    School and Graduate Institute of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

November 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

October 17, 2011

Record last verified: 2011-02

Locations