Balance Training in Parkinson's Disease Using the Wii Balance Board
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance Training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Rehabilitation, Balance, Exercise, Parkinson's disease with balance deficits, H&Y 2.5-3
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Physical Therapy during the study duration
- Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.
Sites / Locations
- Rehabilitation Institute of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Balance Training
Arm Description
Balance training using Wii Fit Balance Board
Outcomes
Primary Outcome Measures
Berg Balance Scale
Secondary Outcome Measures
Dynamic Gait Index
Parkinson's Disease QOL Questionnaire (PDQ-8)
Postural Sway
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01228851
Brief Title
Balance Training in Parkinson's Disease Using the Wii Balance Board
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study is a cohort study using outpatients with Parkinson's Disease in Hoen and Yahr Stage 2.5 - 3. Participants will have pre- and post-exercise testing, as well as participate in an 8-week balance-training program.
Subjects Subjects will be recruited from the outpatient clinics (physician, therapy) at the Rehabilitation Institute of Chicago (RIC) as well as the Northwestern Movement Disorders Clinic, through the Department of Neurology. Approximately 20 subjects will be screened for inclusion from these institutions and 12 subjects will be enrolled in the study. (see Power analysis below).
Recruitment Procedures
Potential subjects will be approached by their treating outpatient physician (Physiatrist or Neurologist) or Physical or Occupational Therapist to see if they would be interested in participating in the study. The principal investigator will also send introductory letters to his outpatients at RIC informing them of the study. Letters will only be sent to the PI's patients (Dr. Marciniak, Dr. Toledo). Potential subjects will be educated regarding study procedures, risks and benefits, and privacy risks. Informed consent will be obtained only during initial screening and signed if the patient is interested in proceeding. Eligibility criteria will be screened for (See below). Subjects who lack decisional capacity will not included in the study.
Study Procedures This study will involve an initial visit (Visit 1) for screening and baseline data collection. The therapy/intervention sessions will be held 3 times per week for 8 weeks, (Visits 2 - 25), and there will be 1 post-intervention visit for data collection (Visit 26). Subjects will be reimbursed 11 dollars for parking expenses that will be mailed to them weekly in the form of a check. All visits will take place at Abbott Hall, 3rd floor exercise room and all visits will take approximately 1 ½ hrs.
Visit 1
Following consent, the following baseline measures will be performed:
Physician screening with a medical history (including falls in the month prior to the visit) and physical examination
Mini Mental Status Examination (MMSE)
Hoehn and Yahr Staging
Questionnaires:
Activities-Specific Balance Scale
Parkinson's Disease Quality of Life measure (PDQ-8 c. Geriatric Depression Scale.
Berg Balance Scale, performed by a trained physical therapist
Dynamic Gait Index, performed by the physical therapist
Gait and mobility subscales of the UPDRS
Sharpened Romberg with eyes open and closed
Balance will also be measured using the Wii balance board. Subjects will stand on the board and a gait belt will be placed around their waist. Subjects will have an accelerometer (done via smart phone) clipped to their waist to measure sway, they will stand on the Wii board, and the subject's ability to performing a reaching task will be assessed, as measured by postural sway.
The investigator will remain immediately next to the subject during the testing procedures for safety purposes with the gait belt in place, and a balance bar will also be next to the patient during the testing procedures.
Visits 2- 25 (3x/ week for 8 weeks) (Within 2 weeks of initial testing) The subjects will be seen at the Wirtz Sports Center exercise room. They will participate in 3 Wii balance board games: a marble game, a skiing game, and a bubble game. Each subject will stand on a balance board and participate in each of the 3 games for 10 minutes per game with 10 minutes rest in between each of the games, a total of 30 minutes of balance training time per session. Subjects will have a gait belt in place during the exercises, and will be supervised by a physical therapist or research assistant. Either the Physical therapist or Research Assistant will always be immediately next to the subjects during the training program. A balance bar will also be next to the subject if needed for balance.
Weekly, subjects will be asked about any changes in medications or falls that they may have experienced at home or in the community.
Visit 26
Subjects will seen for follow up assessments within 2 weeks of the final training session and the following tests repeated:
Interval history (including falls), exam, Hoehn and Yahr Staging
Questionnaires:
Activities-Specific Balance Scale
PDQ-8
Geriatric Depression Scale.
Berg Balance Scale
Dynamic Gait Index
United Parkinson Disease Rating Scale, subscales
Sharpened Romberg
Wii Balance Board Testing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Rehabilitation, Balance, Exercise, Parkinson's disease with balance deficits, H&Y 2.5-3
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance Training
Arm Type
Experimental
Arm Description
Balance training using Wii Fit Balance Board
Intervention Type
Other
Intervention Name(s)
Balance Training
Other Intervention Name(s)
Wii (Registered Trademark) Balance Board
Intervention Description
Group balance training sessions three times a week for 8 weeks
Primary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dynamic Gait Index
Time Frame
8 weeks
Title
Parkinson's Disease QOL Questionnaire (PDQ-8)
Time Frame
8 weeks
Title
Postural Sway
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Physical Therapy during the study duration
Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
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Balance Training in Parkinson's Disease Using the Wii Balance Board
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