Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01228851
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balance Training in Parkinson's Disease Using the Wii Balance Board
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1. Physician screening with a medical history (including falls in the month prior to the visit) and physical examination
2. Mini Mental Status Examination (MMSE)
3. Hoehn and Yahr Staging
4. Questionnaires:
1. Activities-Specific Balance Scale
2. Parkinson's Disease Quality of Life measure (PDQ-8 c. Geriatric Depression Scale.
5. Berg Balance Scale, performed by a trained physical therapist
6. Dynamic Gait Index, performed by the physical therapist
7. Gait and mobility subscales of the UPDRS
8. Sharpened Romberg with eyes open and closed
9. 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:
1. Interval history (including falls), exam, Hoehn and Yahr Staging
2. Questionnaires:
1. Activities-Specific Balance Scale
2. PDQ-8
3. Geriatric Depression Scale.
3. Berg Balance Scale
4. Dynamic Gait Index
5. United Parkinson Disease Rating Scale, subscales
6. Sharpened Romberg
7. Wii Balance Board Testing
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:
1. Physician screening with a medical history (including falls in the month prior to the visit) and physical examination
2. Mini Mental Status Examination (MMSE)
3. Hoehn and Yahr Staging
4. Questionnaires:
1. Activities-Specific Balance Scale
2. Parkinson's Disease Quality of Life measure (PDQ-8 c. Geriatric Depression Scale.
5. Berg Balance Scale, performed by a trained physical therapist
6. Dynamic Gait Index, performed by the physical therapist
7. Gait and mobility subscales of the UPDRS
8. Sharpened Romberg with eyes open and closed
9. 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:
1. Interval history (including falls), exam, Hoehn and Yahr Staging
2. Questionnaires:
1. Activities-Specific Balance Scale
2. PDQ-8
3. Geriatric Depression Scale.
3. Berg Balance Scale
4. Dynamic Gait Index
5. United Parkinson Disease Rating Scale, subscales
6. Sharpened Romberg
7. Wii Balance Board Testing
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: