Computer-Based Balance Training for People With Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01162226|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : April 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: gait and balance training program||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||"PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|Experimental: training program||
Behavioral: gait and balance training program
The intervention will be implemented via three 50-minute training sessions per week for 12 weeks. The games will be played when the subject is receiving the maximum benefit from their anti-parkinsonian medications. The control group and the intervention group will receive weekly telephone calls to inquire about medications and falls. At baseline and end of the 12 weeks, in-home testing will determine stride length and speed; standing balance eyes open and closed on flat and foam surface.
- gait [ Time Frame: 3 months ]Gait velocity and stride length will be measured with WriteStep Gait and Mobility pads (Abilitations). For the gait analysis, subjects will walk along a 10 foot walkway (gait velocity) that will record the footprint patterns from which we will evaluate the time it takes to walk the distance of the walkway and the average stride length. Each subject will walk according to standard protocol of 1 trial at his/her self-selected speed to enable an accurate representation of usual gait.
- balance [ Time Frame: 3 months ]Balance will be objectively measured using the modified Clinical Test for Sensory Interaction and Balance (CTSIB) (Shumway-Cook & Horak, 1986). There are 2 conditions with a stable platform (eyes open and eyes closed) and 2 conditions on a less stable foam surface, (eyes open and eyes closed). Following the standardized protocol, subjects will be tested 3 times in each condition on the stable surface and 3 times in each unstable condition for up to thirty seconds each. The number of seconds standing will be summed across all 12 trials for a range of 0-360 seconds.
- falls [ Time Frame: weeks 1-12 ]Weekly phone inquiry will quantify number of falls if any, during the past week.
- overall functional status [ Time Frame: 3 months ]Functional status will be assessed by the Unified Parkinson's Disease Rating Scale (UPDRS, Parts 2 & 3) (Fahn, Elton, & Members of the UPDRS Committee, 1987). Part 2 is a quantitative 5-point scale that measures the subjects' perception of their functional status. Part 3 is also a 5-point scale in which a clinician evaluates actual functional status by physical exam. The scores on each item in Parts 2 & 3 are summed to yield a total score.
- subjective balance [ Time Frame: 3 months ]Subjective balance will be assessed by the Activities-specific Balance Confidence (ABC) Scale (Powell & Myers, 1995). This instrument assesses subjective balance/fear of falling by asking subjects to rate the degree of confidence that they have for completing 16 activities of daily living without falling. Ratings are summed and then divided by 16 (or the number of items completed) to yield a total ABC score.
- balance [ Time Frame: 3 months ]Timed up and go test (TUG) will be a secondary measure of balance. Subjects are seated in a straight back chair with arms. On the command "GO" the stop watch is started. Subject stands, walks toward a visible object on the floor positioned 8 feet from chair, walk around the object, return to chair and sit down. After a practice, 3 TUG will be performed. Times will be documented in seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162226
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0610|
|Principal Investigator:||Glenna A Dowling, PhD||University of Ca San Francisco|