Condition category
Musculoskeletal Diseases
Date applied
16/12/2003
Date assigned
16/02/2004
Last edited
12/10/2016
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 Anthony Redmond

ORCID ID

Contact details

Rheumatology and Rehabilitation Research Unit
University of Leeds
36
Clarendon Rd
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 343 4938
a.redmond@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130641

Study information

Scientific title

Foot and Lower EXtremity In hypermobility

Acronym

FLEXI

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Joint Hypermobility Syndrome

Intervention

Patients are randomised to one of two groups. Group A is treated using functional foot orthoses, Group B is treated using shock absorbing soles.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

31/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

108 patients with joint hypermobility

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

108

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2000

Recruitment end date

31/05/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
+44 (0)1246 558033
info@arc.org.uk

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign RO612

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

12/10/2016: No publications found in PubMed, verifying study status with principal investigator.