Disorder of arteries and arterioles, unspecified Not Applicable
Conditions
Interventions
Multi-centre, randomised controlled, open feasibility study, using a 1:1 randomisation ratio, patients will be block randomised, stratified by prosthetics centre.
The study will look at the randomisa
Sponsors
Hull & East Yorkshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. Study consent/retention rates and proposed sample sizes indicate recruitment for the full-scale RCT is plausible within a 24-month period 2. Outcome measures and fidelity evaluation data are successfully collected 3. There are no significant barriers to delivery of the trial identified by participants or recruiting centres | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient recruitment rate 2. Barriers to recruitment, how these might be overcome from the perspective of patients, and the most important outcomes to them 3. The acceptability of the study procedures to both participants and recruiting centres 4. Patient use of NHS resources over the study period related to the research 5. Identify a primary outcome measure(s) for a future main trial (if feasibility is established) 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 7. Day-to-day use of the prosthesis in both groups and measure normal physical activity through the use of wearable technologies (activity monitors) | — |
Countries
England, United Kingdom
Outcome results
None listed