Condition category
Musculoskeletal Diseases
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
12/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.atriummc.nl/#http://www.atriummc.nl/

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

Publication citations

Additional files

Editorial Notes