Foot and lower extremity in hypermobility
| ISRCTN | ISRCTN85595438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85595438 |
| Protocol serial number | N0436130641 |
| Sponsor | Arthritis Research Campaign |
| Funder | Arthritis Research Campaign RO612 |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
