Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)
Introduction The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, po...
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e032924.full |
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| author | Elizabeth Coleman Catriona McDaid Natasha Mitchell Judith Watson Kerry Bell Cleveland Barnett Martin Twiste Fergus Jepson Abayomi Salawu Dennis Harrison Natalie Vanicek |
| author_facet | Elizabeth Coleman Catriona McDaid Natasha Mitchell Judith Watson Kerry Bell Cleveland Barnett Martin Twiste Fergus Jepson Abayomi Salawu Dennis Harrison Natalie Vanicek |
| author_sort | Elizabeth Coleman |
| collection | DOAJ |
| description | Introduction The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.Methods and analysis This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.Ethics and dissemination Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration number ISRCTN15043643. |
| format | Article |
| id | doaj-art-5956f5e111574b3db87825c66780c07b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5956f5e111574b3db87825c66780c07b2024-11-29T02:20:08ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-032924Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)Elizabeth Coleman0Catriona McDaid1Natasha Mitchell2Judith Watson3Kerry Bell4Cleveland Barnett5Martin Twiste6Fergus Jepson7Abayomi Salawu8Dennis Harrison9Natalie Vanicek10York Trials Unit, Department of Health Sciences, University of York, York, UKYork Trials Unit, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UK2 York Trials Unit, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKSchool of Science and Technology, Nottingham Trent University, Nottingham, UKSchool of Health and Society, University of Salford, Manchester, UKSpecialist Mobility Rehabilitation Centre, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKDisability Medicine and Rehabilitation Unit, Hull University Teaching Hospitals NHS Trust, Hull, UKPublic Involvement Member, UK, UKDepartment of Sport, Health and Exercise Science, University of Hull, Hull, UKIntroduction The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.Methods and analysis This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.Ethics and dissemination Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration number ISRCTN15043643.https://bmjopen.bmj.com/content/9/9/e032924.full |
| spellingShingle | Elizabeth Coleman Catriona McDaid Natasha Mitchell Judith Watson Kerry Bell Cleveland Barnett Martin Twiste Fergus Jepson Abayomi Salawu Dennis Harrison Natalie Vanicek Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) BMJ Open |
| title | Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) |
| title_full | Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) |
| title_fullStr | Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) |
| title_full_unstemmed | Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) |
| title_short | Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) |
| title_sort | self aligning prosthetic device for older patients with vascular related amputations protocol for a randomised feasibility study the stepforward study |
| url | https://bmjopen.bmj.com/content/9/9/e032924.full |
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