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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01228851
Date of registration: 31/08/2010
Prospective Registration: No
Primary sponsor: Rehabilitation Institute of Chicago
Public title: Balance Training in Parkinson's Disease Using the Wii Balance Board
Scientific title: A Pilot Study of the Effects of Balance Training Using the Wii Balance Board on Balance and Ambulation in Adults With Parkinson's Disease
Date of first enrolment: August 2010
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01228851
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult, 18 years or greater

2. The patient is able to provide informed consent.

3. Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist

4. Hoehn and Yahr Stage 2.5-3

5. Able to ambulate at least 150 ft without an assistive device per patient report

6. On stable doses of Parkinson's medications for at least 2 weeks prior to study onset

7. Endurance sufficient to stand at least 20 minutes unassisted per patient report

Exclusion Criteria:

1. Mini Mental Status Exam (MMSE) < 24

2. Anticipated change in Parkinson's medications in the duration of study

3. Uncontrolled orthostasis

4. Symptomatic coronary artery disease

5. Fracture of lower limb within 6 months prior to study onset

6. Other neurologic diagnosis, including Multiple Sclerosis

7. Other vestibular disease

8. Untreated severe depression (depression of greater than or equal 20 on the Geriatric
Depression Scale)

9. Acute illness

10. History of, or current, alcohol abuse

11. Significant visual impairment that would inhibit ability to participate in study,
with distance vision >20/40

12. Drug induced or inherited Parkinson's Disease

13. Physical therapy within the month prior to study entry

14. Use of the Wii balance board at home as an exercise program

15. Significant camptocormia

16. Physical Therapy during the study duration

17. Any medical condition which the physician investigator determines would compromise
the safety of exercise program for the subject.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Other: Balance Training
Primary Outcome(s)
Berg Balance Scale [Time Frame: 8 weeks]
Secondary Outcome(s)
Dynamic Gait Index [Time Frame: 8 weeks]
Parkinson's Disease QOL Questionnaire (PDQ-8) [Time Frame: 8 weeks]
Postural Sway [Time Frame: 8 weeks]
Secondary ID(s)
30775
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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