| - candidate number | 2565 |
| - NTR Number | NTR963 |
| - ISRCTN | incomplete |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 24-apr-2007 |
| - Secondary IDs | |
| - Public Title | A new method to objectively observe the function of orthopaedic patients. |
| - Scientific Title | A new inertial based method to objectively observe the function of orthopaedic patients. |
| - ACRONYM | N/A |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | |
| - Inclusion criteria | All orthopaedic patients visiting the policlinic of the orthopaedic department of the Atrium MC Heerlen. |
| - Exclusion criteria | 1. Unable to perform the tasks: a. walk 20m; b. balance on one leg; c. rise from and sit down onto a chair; d. step onto and down from a block. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-mei-2007 |
| - planned closingdate | 1-mei-2008 |
| - Target number of participants | 50 |
| - Interventions | Measure function during policlinical visits using a triaxial accelerometer: walk 20m, balance on 1 leg, rise from and sit down onto a chair, step onto and down from a block. These tests takes about 10 minutes. The obtained data is compared with data of a healthy control group. Furthermore it will be validated with the usual observations of the doctor. |
| - Primary outcome | The possibility to determine the function of orthopaedic patients with a triaxial accelerometer. The acceleration signals are analysed using algorithms programmed in matlab. Important parameters are gait parameters (frequency, speed, steptime, asymmetry, regularity, up down displacement) and balance parameters (postural sway, trunk angles, angel velocities, root mean squares). |
| - Secondary outcome | N/A |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | I.C Heyligers |
| - CONTACT for SCIENTIFIC QUERIES | B. Grimm |
| - Sponsor/Initiator | Atrium Heerlen Orthopaedic Research and Schientific Education (AHORSE) , University Maastricht (UM), Department Movement Science |
| - Funding (Source(s) of Monetary or Material Support) | University Maastricht (UM), Atrium Medisch Centrum Parkstad |
| - Publications | One or two papers. Scientific presentations or posters. |
| - Brief summary | A new objective functional assessment tool is needed to analyse the patients of today which have higher functional requirements compared with 20 years ago. This study will use a triaxial accelerometer to observe the mobility in orhtopedic patiens during the plyclinic visits. |
| - Main changes (audit trail) | |
| - RECORD | 24-apr-2007 - 28-apr-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl