NCT01228851

Brief Summary

The purpose of this study is to assess the facilitation of balance in Parkinson's disease (PD) patients using the Nintendo Wii fit, with the ultimate goal of developing a program for function and fitness in this patient population. In this study, PD patients will participate in group exercise classes using the Wii Fit and the effects on balance, postural sway, and quality of life assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

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

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

3 months

First QC Date

August 31, 2010

Last Update Submit

July 26, 2011

Conditions

Keywords

Parkinson's DiseaseRehabilitationBalanceExerciseParkinson's disease with balance deficitsH&Y 2.5-3

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    8 weeks

Secondary Outcomes (3)

  • Dynamic Gait Index

    8 weeks

  • Parkinson's Disease QOL Questionnaire (PDQ-8)

    8 weeks

  • Postural Sway

    8 weeks

Study Arms (1)

Balance Training

EXPERIMENTAL

Balance training using Wii Fit Balance Board

Other: Balance Training

Interventions

Group balance training sessions three times a week for 8 weeks

Also known as: Wii (Registered Trademark) Balance Board
Balance Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, 18 years or greater
  • The patient is able to provide informed consent.
  • Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
  • Hoehn and Yahr Stage 2.5-3
  • Able to ambulate at least 150 ft without an assistive device per patient report
  • On stable doses of Parkinson's medications for at least 2 weeks prior to study onset
  • Endurance sufficient to stand at least 20 minutes unassisted per patient report

You may not qualify if:

  • Mini Mental Status Exam (MMSE) \< 24
  • Anticipated change in Parkinson's medications in the duration of study
  • Uncontrolled orthostasis
  • Symptomatic coronary artery disease
  • Fracture of lower limb within 6 months prior to study onset
  • Other neurologic diagnosis, including Multiple Sclerosis
  • Other vestibular disease
  • Untreated severe depression (depression of greater than or equal 20 on the Geriatric Depression Scale)
  • Acute illness
  • History of, or current, alcohol abuse
  • Significant visual impairment that would inhibit ability to participate in study, with distance vision \>20/40
  • Drug induced or inherited Parkinson's Disease
  • Physical therapy within the month prior to study entry
  • Use of the Wii balance board at home as an exercise program
  • Significant camptocormia
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2010

First Posted

October 27, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations