A new method to objectively observe the function of orthopaedic patients

ISRCTN	ISRCTN02163948
DOI	https://doi.org/10.1186/ISRCTN02163948
Secondary identifying numbers	NL942 (NTR967)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr R. Senden
Scientific

Hoogstraat 229
Voeren
B-3798
Belgium

Phone	+32 (0)62 3043131
Email	rachel.senden@bw.unimaas.nl

Study design	Observational study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	A new method to objectively observe the function of orthopaedic patients
Study objectives	The use of an objective device (accelerometer) to analyse function is more accurate than the currently used methods (observing by eyes).
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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 doctors observation and questionnaires.
Intervention type	Other
Primary outcome measure	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 study start date	15/05/2007
Completion date	01/05/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Key inclusion criteria	All orthopaedic patients visiting the policlinic of the orthopaedic department of the Atrium Medical Centre Heerlen.
Key exclusion criteria	Unable to perform the tasks (walking, balacing, rising from a chair, step on a block).
Date of first enrolment	15/05/2007
Date of final enrolment	01/05/2008

Hoogstraat 229

Voeren
B-3798
Belgium

Atrium Heerlen Orthopaedic Research and Scientific Education (AHORSE) (The Netherlands)
Hospital/treatment centre

Atrium Medical Centre
P.O. Box 4446
Heerlen
6401 CX
Netherlands

Website	http://www.atriummc.nl/#http://www.atriummc.nl/
"ROR"	https://ror.org/0367sye10

Hospital/treatment centre

Atrium Medical Centre (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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