Condition category
Injury, Occupational Diseases, Poisoning
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
12/03/2007
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 G Snoek

ORCID ID

Contact details

Roessingh Research and Development B.V.
Reoessinghsbleekweg 33 B
Enschede
7522 AH
Netherlands
+31 (0)53 487 5777
g.snoek@rrd.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

014-32-026 and 96-06-004

Study information

Scientific title

Acronym

Study hypothesis

To assess the effect of treatment characteristics on the decisions made by subjects with tetraplegia concerning reconstructive interventions for the upper extremities.

Ethics approval

Approval received from the Medisch Ethische Toetsingscommissie ( Medical-ethical board) of Roesingh Rehabilitation Centre on the 27th February 2002 (ref: 02.08.7.2).

Study design

Survey

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Spinal cord injury

Intervention

Seven specialised spinal cord injury centres in the Netherlands. 53 individuals with tetraplegia in a stable condition were surveyed on the importance and the relative weight of seven treatment characteristics:
1. Type of intervention
2. Number of operations
3. Inpatient rehabilitation period
4. Outpatient rehabilitation period
5. Risk of complications
6. Results of elbow function
7. Results of hand function

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Importance and the relative weight of seven treatment characteristics on the decision to undergo reconstructive surgery determined by means of Conjoint Analysis.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/09/2002

Overall trial end date

01/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. A motor complete C5, C6 or C7 Spinal Cord Injury (SCI), according to the guidelines of the American Spinal Injury Association (ASIA)
2. At least one arm classified as motor group one to four according to the International Classification for Surgery of the Upper Limb in Tetraplegia
3. Subjects had to be medically and neurologically stable
4. At least one year after the initial injury
5. Possible candidates for surgical reconstruction of elbow extension and palmar and/or lateral grasp function

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

53

Participant exclusion criteria

1. Previously undergone surgery to improve Upper Extremity (UE) function
2. Extensively informed about these interventions
3. Declined treatment in the past five years

Recruitment start date

05/09/2002

Recruitment end date

01/02/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Roessingh Research and Development B.V.
Enschede
7522 AH
Netherlands

Sponsor information

Organisation

Roessingh Research and Development B.V. (The Netherlands)

Sponsor details

P.O. Box 310
Enschede
7500 AH
Netherlands
+31 (0)53 487 5777
info@rrd.nl

Sponsor type

Industry

Website

http://www.rrd.nl/www/indexa.html

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (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