Contact information
Type
Scientific
Primary contact
Dr R. Senden
ORCID ID
Contact details
Hoogstraat 229
Voeren
B-3798
Belgium
+32 (0)62 3043131
rachel.senden@bw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The use of an objective device (accelerometer) to analyse function is more accurate than the currently used methods (observing by eyes).
Ethics approval
Received from the local ethics committee (METC Atrium MC - Maaslandziekenhuis). The commitee concluded on the 26th March 2007 that the research is not WMO- obligated and permission was granted.
Study design
Observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Orthopaedic patients, accelerometer
Intervention
An accelerometer, attached to the sacrum of the subject using an elastic belt, measures accelerations in three directions when the doctor observes the patient as usual (walk ability, sit to stand, balancing, etc). The objective outcome will be compared with the doctorsÂ’ observation and questionnaires.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Parameters which give information about the function of the patient like walk speed, asymmetry during walking, postural sway during balancing etc. These will be measured at the end of the doctors investigation.
Secondary outcome measures
Patient data like weight, height, date of birth and the health state of the patient is collected. These will be measured at the end of the doctors investigation.
Overall trial start date
15/05/2007
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All orthopaedic patients visiting the policlinic of the orthopaedic department of the Atrium Medical Centre Heerlen.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Unable to perform the tasks (walking, balacing, rising from a chair, step on a block).
Recruitment start date
15/05/2007
Recruitment end date
01/05/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Hoogstraat 229
Voeren
B-3798
Belgium
Sponsor information
Organisation
Atrium Heerlen Orthopaedic Research and Scientific Education (AHORSE) (The Netherlands)
Sponsor details
Atrium Medical Centre
P.O. Box 4446
Heerlen
6401 CX
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Atrium Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary