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 |
| Secondary identifying numbers | AP0985 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Measured pressure distribution, patient activity level and patients opinion elucidated by validated questionnaire for two socket concepts. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 05/04/2004 |
| Completion date | 04/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
NCTEPO
Glasgow
G4 0LS
United Kingdom
G4 0LS
United Kingdom
Sponsor information
University of Strathclyde (UK)
University/education
University/education
16 Richmond Street
Glasgow
G1 1XQ
Scotland
United Kingdom
| Website | http://www.strath.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00n3w3b69 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
