Parkinson's DiseaseNCT01228851
Balance Training in Parkinson's Disease Using the Wii Balance Board
A study testing Balance Training in people with Parkinson's Disease, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
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
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.
Read the 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
- Conditions
- Parkinson's Disease
- Being tested
- Balance Training
- Keywords
- Parkinson's Disease, Rehabilitation, Balance, Exercise, Parkinson's disease with balance deficits, H&Y 2.5-3
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
Also called Wii (Registered Trademark) Balance Board
Group balance training sessions three times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance Training | Experimental | Balance training using Wii Fit Balance Board Receives: Other: Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: 8 weeks
Secondary outcomes (3)
Dynamic Gait Index
Measured: 8 weeks
Parkinson's Disease QOL Questionnaire (PDQ-8)
Measured: 8 weeks
Postural Sway
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228851
- Sponsor's protocol ID
- 30775
- Status last verified
- Jul 2011
- First submitted
- 31 Aug 2010
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01228851
- Acronym / sponsor ID
- 30775
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Rehabilitation, Balance, Exercise, Parkinson's disease with balance deficits, H&Y 2.5-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Experimental | Other: Balance TrainingBalance training using Wii Fit Balance Board |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance TrainingAlso: Wii (Registered Trademark) Balance BoardGroup balance training sessions three times a week for 8 weeks | Other | Balance Training |
Primary outcome
Berg Balance Scale
Time frame: 8 weeks
3 secondary outcomes
Dynamic Gait Index
Time frame: 8 weeks
Parkinson's Disease QOL Questionnaire (PDQ-8)
Time frame: 8 weeks
Postural Sway
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training in people with Parkinson's Disease, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.