| - candidate number | 2572 |
| - NTR Number | NTR967 |
| - ISRCTN | ISRCTN02163948 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 3-mei-2007 |
| - Secondary IDs | |
| - Public Title | A new method to objectively observe the function of orhtopaedic patients. |
| - Scientific Title | A new method to objectively observe the function of orhtopaedic patients. |
| - ACRONYM | |
| - hypothesis | The use of an objective device (accelerometer) to analyse function is more accurate than the currently used methods (observing by eyes). |
| - Healt Condition(s) or Problem(s) studied | Accelerometer, Orthopaedic patients |
| - Inclusion criteria | All orthopaedic patients visiting the policlinic of the orthopaedic department of the Atrium MC Heerlen. |
| - Exclusion criteria | Unable to perform the tasks (walking, balacing, rising from a chair, step on a block) |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 15-mei-2007 |
| - planned closingdate | 1-mei-2008 |
| - Target number of participants | 100 |
| - Interventions | An accelerometer, attached to the sacrum of the subject using an elastic belt, measures accelerations in 3 directions when the doctor observes the patient as usual (walk ability, sit to stand, balancing...). The objective outcome will be compared with the doctors observation and questionnaires. |
| - Primary outcome | Parameters which give information about the function of the patient like walk speed, asymmetry during walking, postural sway during balancing ect. |
| - Secondary outcome | Patient data like weight, height, date of birth and the health state of the patient is collected. |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs R. Senden |
| - CONTACT for SCIENTIFIC QUERIES | I.C Heyligers |
| - Sponsor/Initiator | Atrium Heerlen Orthopaedic Research and Schientific Education (AHORSE) |
| - Funding (Source(s) of Monetary or Material Support) | Atrium Medisch Centrum Parkstad |
| - Publications | One or two papers. Scientific presentations or posters |
| - Brief summary | The patient of today has higher requirements compared to 20 years ago. For these reasons new objective functional assessment tools are needed. At the moment function is assessed visually by the doctor or by questionnaires which have to be filled in by the patient it selves, which are subjective and not accurate. Previous performed studies used accelerometers for several targets. Based on the promising results of these studies, accelerometers seem appropriate methods to objectively and acurately analyse function of orthopaedic patients. In this study, we will use the accelerometer while observing the mobility in orthopaedic patients during the polyclinic visits. |
| - Main changes (audit trail) | |
| - RECORD | 3-mei-2007 - 11-jun-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl