STEPFORWARD: Patient acceptability of a novel prosthetic device
- Conditions
- Disorder of arteries and arterioles, unspecifiedNot Applicable
- Registration Number
- ISRCTN15043643
- Lead Sponsor
- Hull & East Yorkshire NHS Trust
- Brief Summary
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31542768/ protocol (added 06/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33737440/ (added 22/03/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37088918/ Qualitative experience (added 24/04/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 55
Current inclusion criteria as of 10/05/2018:
1. Aged over 50 years
2. Has a unilateral amputation
3. Has a below-knee amputation only
4. Has an amputation due to vascular reasons (diabetes, peripheral vascular disease), neurological disorders (i.e. diabetic neuropathy) or life-limiting illness (i.e. tumour, cancer)
5. Is categorised as 'limited mobility’ (K2 classification or SIGAM mobility grade C or D)
6. Is currently using a standard prosthetic foot-ankle (e.g. SACH, uniaxial, multiflex or other K1/K2 feet) that does not adjust to sloped surfaces and is not self-aligning
7. Has been using a prosthesis for at least 12 months, with the same socket for a minimum of 3 months
8. Has had a stable residual limb for at least 3 months (i.e. stable in volume and without cuts or wounds; daily management of volume with socks and liners is acceptable)
9. Is willing to trial a new prosthesis for a 12-week period (if allocated to intervention arm)
10. Is able to self-complete the English language outcome measure tools (or complete with assistance)
11. Is able to follow the detailed verbal instructions required for the functional/clinical tests
12. Is able to provide written informed consent
Previous inclusion criteria:
1. Aged over 50 years
2. Has a unilateral amputation
3. Has a below knee amputation only
4. Has an amputation due to vascular reasons (diabetes, peripheral vascular disease), neurological disorders (i.e., diabetic neuropathy) or life-limiting illness (i.e. tumour, cancer)
5. Is categorised as ‘limited mobility’ (K2 classification or SIGAM mobility grade C or D)
6. Is currently using a standard prosthetic foot-ankle (e.g., SACH, uniaxial, multiflex or other K1/K2 feet) that does not adjust to sloped surfaces and is not self-aligning
7. Has been using a prosthesis for at least 12 months
8. Has had a stable residual limb for at least 3 months (i.e. stable in volume and without cuts or wounds)
9. Is willing to trial a new prosthesis for a 12-week period (if allocated to intervention arm)
10. Is able to self-complete the English language outcome measure tools (or complete with assistance)
11. Is able to follow the detailed verbal instructions required for the functional/clinical tests
12. Is willing to have their GP informed of their involvement in the study
13. Is able to provide written informed consent
A patient will be excluded for the following reasons:
1. Has contraindications of wearing their current prosthesis (e.g., open wound, infection)
2. Has contraindications of wearing the novel prosthesis according to manufacturer’s instructions (i.e., a long residual limb - intact side measurement from mid patella tendon to ground minus the socket measurement from mid patella tendon to distal end of socket female-pyramid-adaptor should be at least 115mm)
3. Has had a recent cerebrovascular event, such as a stroke
4. Has a disease that severely affects their memory, such as dementia or Alzheimer’s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The feasibility of conducting a future, full scale RCT into the effectiveness and cost-effectiveness of a novel prosthesis for older patients with vascular-related amputations and other health issues compared to a standard rigid prosthesis. This will be assessed based on whether:<br>1. Study consent/retention rates and proposed sample sizes indicate recruitment for the full-scale RCT is plausible within a 24-month period<br>2. Outcome measures and fidelity evaluation data are successfully collected<br>3. There are no significant barriers to delivery of the trial identified by participants or recruiting centres
- Secondary Outcome Measures
Name Time Method 1. Patient recruitment rate<br>2. Barriers to recruitment, how these might be overcome from the perspective of patients, and the most important outcomes to them<br>3. The acceptability of the study procedures to both participants and recruiting centres<br>4. Patient use of NHS resources over the study period related to the research<br>5. Identify a primary outcome measure(s) for a future main trial (if feasibility is established)<br>6. The completeness of follow-up to establish how feasible it is to collect patient-reported outcome measures including data related to patient function, health status, adverse events and use of the NHS<br>7. Day-to-day use of the prosthesis in both groups and measure normal physical activity through the use of wearable technologies (activity monitors)