NCT01580787

Brief Summary

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. The study was finished at december 2011.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

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, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

April 16, 2012

Last Update Submit

April 18, 2012

Conditions

Keywords

Parkinson´s diseasePostural Balancevirtual reality

Outcome Measures

Primary Outcomes (1)

  • UNIFIED PARKINSON'S DISEASE RATING SCALE

    The scale assesses the functional status of patients with parksinon´s disease, including the independency of daily activities, mood, secondary effects of medications and motor complications.

    08/2011 (up to 2 years)

Secondary Outcomes (1)

  • Berg Balance Scale

    08/2011 (up to 2 years)

Study Arms (2)

Virtual Reality Training

EXPERIMENTAL

The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.

Device: Balance Training with Nintendo Wii Fit

Physical Therapy

ACTIVE COMPARATOR

The Control Group was trained by conventional Physical Therapy exercises.

Other: Physical Therapy

Interventions

The participants of the study trained 10 balance games during 14 sessions.

Virtual Reality Training

Patients of the control group was trained with balance exercises.

Physical Therapy

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with Parkinson´s disease
  • both gender
  • on stages 1 and 2,5 of Hoehn e Yahr

You may not qualify if:

  • depression
  • cognitive impairment
  • deficits of visual acuity
  • Score on Berg Balance Scale under 46

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • José E Pompeu, PhD

    Sao Camilo University Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

April 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04