|- candidate number||13235|
|- NTR Number||NTR3577|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-aug-2012|
|- Secondary IDs|| 12-N-84 METC Artium Orbis Zuyd|
|- Public Title||Measuring balance with a modified bathroom scale.|
|- Scientific Title||Predictive validity of a modified bathroom scale that measures balance.|
|- hypothesis||Elderly persons aged 65 or older with a low balance score on the bathroom scale have a higher risk of falling, development of disability, and hospital admission in the next 6 months compared to elderly persons with a high balance score. |
|- Healt Condition(s) or Problem(s) studied||Older adults, Falling, Disabilities, Hospitalization, Balance|
|- Inclusion criteria||1. Aged 65 years or older;|
2. Able to step onto a bathroom scale.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2012|
|- planned closingdate||31-mei-2013|
|- Target number of participants||400|
|- Primary outcome||At baseline the following measurments will be conducted:|
1. Weight and balance with the modified bathroom scale;
3. Disability with the Groningen Activity Restriction Scale (GARS);
5. Experienced health;
6. Hospital admission.
After 6 months follow-up, participants will receive the same questionnaire as they completed at baseline to measure:
2. Disability with the Groningen Activity Restriction Scale (GARS);
4. Experienced health;
5. Hospital admission.
|- Secondary outcome||N/A|
|- Timepoints||6 months follow-up.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Joan Vermeulen|
|- CONTACT for SCIENTIFIC QUERIES|| Joan Vermeulen|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Elderly people with poor balance have a higher risk of disability and other negative health outcomes compared to elderly people with good balance. Currently, health care professionals often use physical performance tests, such as the Performance Oriented Mobility Assessment (POMA) or the Timed Up and Go (TUG), to measure balance in their patients. To get a good impression of the development of balance over time, performance based tests should be administered on a regular basis. This is very difficult, if not impossible, to accomplish in daily practice. A modified bathroom scale that enables elderly people to measure their own balance by stepping onto the scale could be a solution for this problem. Such a bathroom scale was developed by the University of Technology of Troyes in France. An algorithm is used to extract information regarding balance from the sensors that are embedded in the bathroom scale. The bathroom scale is equipped with Bluetooth® which enables the transfer of balance and weight data to a database that can be accessed by healthcare professionals. Construct validity of the balance measurement of the bathroom scale has been investigated in nursing home patients and community-dwelling elderly people. The bathroom scale balance scores correlated well with clinical performance tests of balance. The current study is set up to study the predictive validity of the bathroom scale balance scores.
At baseline 200 nursing home patients and 200 community elderly people, all aged 65 and older, will be asked to step onto a bathroom scale and to fill out a questionnaire that contains questions regarding health, falling, mobility, use of care, and quality of life. After 6 months follow-up the same questionnaire will be filled out by the participants. Logistic regression models will be used to investigate whether a lower balance score at baseline predicts negative health outcomes (such as disability or falls) after 6 months follow-up.
|- Main changes (audit trail)|
|- RECORD||14-aug-2012 - 8-sep-2012|