Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01228851 |
Date of registration:
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31/08/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Balance Training in Parkinson's Disease Using the Wii Balance Board
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Scientific title:
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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:
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August 2010 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01228851 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Other: Balance Training
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Primary Outcome(s)
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Berg Balance Scale
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Dynamic Gait Index
[Time Frame: 8 weeks]
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Parkinson's Disease QOL Questionnaire (PDQ-8)
[Time Frame: 8 weeks]
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Postural Sway
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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