|- candidate number||13349|
|- NTR Number||NTR3636|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-sep-2012|
|- Secondary IDs||NL41791 CCMO|
|- Public Title||Can the predefined on-body sensing system be used for the qualification of the arm and balance function of patients after stroke.|
|- Scientific Title||Objective qualification of balance control and arm function in stroke subjects using on-body sensing: Evaluation of principles in a simulated ambulatory setting.|
|- hypothesis||The predefined on-body sensing system can be used for the qualification of the arm and balance function of patients after stroke.|
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- Inclusion criteria||1. Age above 35 years;|
2. Age below 75 years;
3. At least 6 months post-stroke;
4. Had only one unilateral ischaemic or haemorrhagic hemiparetic stroke;
5. Ability to lift the arm (at least partly) against gravity, without suffering;
6. Ability to walk (possibly with walking aid) for over 10 meters, without suffering;
7. Ability to walk without specific footwear (ability to walk on sandals);
8. No pain or other condition interfering with the mobility and/or strength of the arm;
9. Ability to understand and perform instructions and questionnaires;
10. Provide written informed consent (IC).
|- Exclusion criteria||1. Medical history of more than one stroke events;|
2. Complicating medical history such as cardiac, pulmonary, or orthopaedic disorders that could affect performance of the included measurements;
3. Severely impaired sensation;
4. Suffering from comprehensive aphasia.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-mei-2013|
|- Target number of participants||20|
|- Interventions||For all subjects the experiment will be the same. No randomization will be aplied, no control group will be included.
During the single measurement session, the sensors will be attached to the body. After calibration, subjects will be asked to perform some specific tasks and complete some clinical tests. The whole measurement session will take about 120 minutes.
|- Primary outcome||Using on-body sensing systems, inertial sensors, force sensors and EMG-sensors; movement, forces and muscle activity will be measured. Measured data will be analyzed and the main study parameters will be calculated. These parameters are subdivided into three groups: temporal (number of movements), kinetic (centre of pressure, underneath the foot) and kinematic (step width, step size, range of motion). Each group contains several parameters of which a combination of parameters and/or (a)symmetry of parameters will be used to qualify motor function.|
|- Secondary outcome||Secondary parameters are the clinical tests (Timed Up and Go Test, Berg Balance Scale, Fugl Meyer, Stroke Upper Limb Capacity Scale, Barthel index) which are already used in clinical practice to assess balance, reaching tasks and daily-life activity. The results of these tests will be correlated to the results of primary study parameters by calculating the regression coefficients and intraclass correlation between the clinical tests and the parameters as described in the main parameters.|
|- Timepoints||One moment.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. F.B. Meulen, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Ir. P.H. Veltink|
|- Sponsor/Initiator ||European Commission|
(Source(s) of Monetary or Material Support)
|Seventh Framework Programme (FP7) funded by the European Union|
|- Brief summary||With the aging of the population, the incidence of stroke is increasing in especially developing countries. Depending on the patientís impairments as a result of the stroke, a patient-specific rehabilitation program is started when he/she is discharged from the hospital after the acute phase. During the subsequent period of intensive training in a rehabilitation centre, the patientís motor function is regularly evaluated. When the patient has an adequate capacity to live at home, the patient is discharged and sent home. Between this moment and the next routine appointment (several months later), patients frequently show deterioration of motor function. In some cases, this deterioration is so severe that re-admission to a rehabilitation centre is necessary. Remarkably, the cause of the deterioration of motor function is unknown in many cases, since the patientís period at home is like a black-box for the physician. If the physician would be able to monitor the patientís motor function at home, he could intervene in case of deterioration and prevent an expensive re-hospitalisation. For this purpose, we develop body-mounted sensing systems that can eventually result in daily-life monitoring. In the current phase, we evaluate monitoring principles in a simulated ambulatory setting. In this cross sectional study described in this document, a combination of two ambulatory human movement analysis systems (Instrumented Force Shoes and an inertial sensing suit) will be used to assess balance and reaching tasks of stroke patients. The results will be evaluated and related to regular clinical tests.
Recruitment only in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||21-sep-2012 - 16-okt-2012|