An interventional study of Balance Training in Parkinson's Disease, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-27.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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.
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:
Questionnaires:
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:
Questionnaires:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Balance training using Wii Fit Balance Board
Other: Balance Training
Group balance training sessions three times a week for 8 weeks
Also known as: Wii (Registered Trademark) Balance Board
Berg Balance Scale
Time frame: 8 weeks
Dynamic Gait Index
Time frame: 8 weeks
Parkinson's Disease QOL Questionnaire (PDQ-8)
Time frame: 8 weeks
Postural Sway
Time frame: 8 weeks
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Shirley Ryan AbilityLab