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Monotoring capacity and performance of stroke patients using instrumented clothing


- candidate number17014
- NTR NumberNTR4481
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2014
- Secondary IDsNL47854.044.14 METC Twente
- Public TitleMonotoring capacity and performance of stroke patients using instrumented clothing
- Scientific TitleMonotoring capacity and performance of stroke patients using instrumented clothing
- ACRONYM-
- hypothesis1) It is possible to record data delivering insights in the actual performance of activities of daily life using the Interaction system in stroke patients in the home environment. 2) It is expected that standard clinical test scores do not necessarily correlate with performance scores measured in the home setting.
- Healt Condition(s) or Problem(s) studiedStroke,
- Inclusion criteria- previous stroke in the personal history, at least 6 months ago - not receiving in-patient therapy - age: 18 or above - able to walk, a walking aid (unilateral or bilateral) is permitted - able to read and understand questionnaires and able to execute commands - able and willing to participate in the study - signed informed consent
- Exclusion criteria- other musculoskeletal problems influencing walking, balance and reaching.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2014
- planned closingdate1-mrt-2015
- Target number of participants10
- InterventionsN/A: observational study open, non-randomized proof of concept pilot study including measurements in a controlled setting and measurements in the home setting while wearing instrumented clothing.
- Primary outcomeEvaluation of possible data loss (% of successful data collection), evaluation of the data (temporal, kinematic, kinetic and EMG of reaching tasks, walking and balance) and subjective evaluation of the system.
- Secondary outcomeStandard clinical tests assessing capacity of walking, balance, arm/hand function and activities of daily life. Furthermore a predefined task is peformed.
- TimepointsThere will be 3 measurement sessions, all performed within one week: 1 in a controlled laboratory setting, 2 in the home setting. Alle sessions will take about 3 hours.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J. Reenalda
- CONTACT for SCIENTIFIC QUERIESDr. J. Reenalda
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
European Commision, Seventh Framework Programme
- PublicationsN/A
- Brief summaryWith the aging of the population, the incidence of stroke is increasing, especially in western countries. Depending on the patientís impairments as a result of the stroke, a patient-specific rehabilitation program is started. When the patient has an adequate capacity to live at home, the patient is discharged and sent home. Sometimes patients show deterioration after leaving the rehabilitation centre. In some cases this is so severe that re-admission to a rehabilitation centre is necessary. Many times, the cause of the deterioration is unknown, 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 instrumented clothing containing sensors that can eventually result in daily-life monitoring. In this pilot study, balance, walking and reaching tasks of stroke patients will be assessed in the home situation. The results will be evaluated and related to regular clinical tests and a predefined task, performed in a controlled laboratory setting.
- Main changes (audit trail)
- RECORD26-mrt-2014 - 24-apr-2014


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