Transtibial prosthetic system design and benefits for the amputee, service providers and society: an evidence based clinical study
| ISRCTN | ISRCTN23271752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23271752 |
| Protocol serial number | AP0985 |
| Sponsor | University of Strathclyde (UK) |
| Funder | Action Medical Research (UK) |
- Submission date
- 22/03/2005
- Registration date
- 14/04/2005
- Last edited
- 07/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brendan McHugh
Scientific
Scientific
NCTEPO
University of Strathclyde
131 St James Rd
Glasgow
G4 0LS
United Kingdom
| Phone | +44 (0)141 548 3692 |
|---|---|
| b.mchugh@strath.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Comparative evaluation of two types of prosthetic transtibial socket leading to better understanding of what constitutes a good socket design. |
| Ethics approval(s) | Added 07/01/2010: Granted ethical approval by the Local Regional Health Authority and University Ethics Committees (ref EC/03/S/66) |
| Health condition(s) or problem(s) studied | Transtibial amputation |
| Intervention | Two groups of patients will each be randomly selected from among those amputees with one of the two socket types under assessment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Measured pressure distribution, patient activity level and patients opinion elucidated by validated questionnaire for two socket concepts. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 04/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | Established amputees previously fitted with hand cast or pressure cast prosthetic sockets. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 05/04/2004 |
| Date of final enrolment | 04/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
NCTEPO
Glasgow
G4 0LS
United Kingdom
G4 0LS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
