Foot and lower extremity in hypermobility
| ISRCTN | ISRCTN85595438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85595438 |
| Secondary identifying numbers | N0436130641 |
- Submission date
- 16/12/2003
- Registration date
- 16/02/2004
- Last edited
- 12/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Dr Anthony Redmond
Scientific
Scientific
Rheumatology and Rehabilitation Research Unit
University of Leeds
36, Clarendon Rd
Leeds
LS2 9NZ
United Kingdom
| Phone | +44 (0)113 343 4938 |
|---|---|
| a.redmond@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Foot and Lower EXtremity In hypermobility |
| Study acronym | FLEXI |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2000 |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 108 |
| Key inclusion criteria | 108 patients with joint hypermobility |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 31/05/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Sponsor information
Arthritis Research Campaign
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
| Phone | +44 (0)1246 558033 |
|---|---|
| info@arc.org.uk | |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign RO612
No information available
Results and Publications
| 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 |
Editorial Notes
12/10/2016: No publications found in PubMed, verifying study status with principal investigator.
