Prosthetic sockets for below-knee amputees Not Applicable Prosthetic sockets
Conditions
Interventions
Amputees are fitted with either ProsFit Original prosthetic sockets or their own existing socket, attached to their standard prosthesis. The patients then are monitored as they carry out a number of p
Sponsors
ProsFit Technologies UK Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Amputee with trans-tibial amputation 2. Aged 18 years or above 3. Patient of SMRC 4. Activity Level Special Interest Group in Amputee Medicine (SIGAM) grade E or F (no significant limitations on walking distance, no use of walking aids, able to walk up shallow slopes and climb stairs, near normal gait or normal gait) 5. Willing and able to attend the planned research Visits, giving full attempt to adhere to the Investigation protocol in good faith (the patient may withdraw from the study at any point, without necessarily providing any reasons for doing so) 6. Willing and able to provide informed consent 7. Has a prosthesis that allows for its components to be disconnected from the traditional socket and then to be connected to the ProsFit Original prosthetic socket, and reconnected back, for the purposes of the research (connecting and reconnecting done by the prosthetist of the investigation team) 8. Uses an appropriate roll-on liner (this is worn between the residuum and the socket for cushioning and prosthesis suspension purposes) and is willing to use it during the Investigation 9. Willing to also use their own socket (non-ProsFit) as a comparator 10. Patient is expected to attend the clinic before and/or during the period in which the clinical investigation is taking place 11. No conflicts of interest related to participation or the results of the Investigation
Exclusion criteria
Exclusion criteria: 1. Pre-existing medical conditions that might put the patient at risk or lead to a failure to complete the study. This includes diabetes, ischaemic heart disease (angina), epilepsy, skin conditions that might lead to skin breakdown such as Ehlers-Danlos Syndrome, chronic obstructive airway disease. 2. Current acute medical conditions such as skin infections, stump sores / blisters or recent trauma to the stump 3. Under 18 4. Mental health disorders that may lead to difficulties with participation or understanding protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical integrity of the ProsFit Original prosthetic socket over the course of use in the clinical investigation, as determined by the prosthetist according to standard clinical inspection (no device deficiencies or failures during use, or signs of impending deficiencies or failures). Socket comfort score, TAPES, EQ-5D-5L, Visual analogue score (pain). In Phase 1: socket inspection, socket comfort score, visual analogue score and PCI are measured at the end of every stage within the phase (approximately every 5 minutes until complete, for total 10 stages). In Phase 2: socket inspection, socket comfort score, and visual analogue score are measured at the end of every stage within the phase (approximately every 3 minutes until complete, for total 20 stages). In Phase 3: socket score and visual analogue score are measured at the end of every stage within the phase (approximately every 3 minutes until complete, for total 6 stages). The 2 min walk test, 6 min walk test, and berg balance score are measured once during this Phase, during stage 2. In Phase 4: (high intensity users only), socket comfort score and visual analogue score are measured at the end of every stage within the phase (approximately every 5 minutes until complete, for total 8 stages). In Phase 5: socket comfort score, visual analogue score, Barthels index, TAPES, EQ 5D 5L, AMPnoPRO are measured at the end of every stage within the phase (at the end of every ADL, for total 6 ADLs). In Phase 6: the gait test is measured/analysed once in this phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| PCI, AMPnoPro, 2 min. walk test, 6 min. walk test, gait test, timed continuous walking, and berg balance score. Outcome measures will be taken at specific intervals (see primary outcome measures field).The questionnaires and outcome measure that are not self-questionnaires will be administered by a member of the team. | — |
Countries
United Kingdom
Contacts
Public ContactChristopher Hutchison
Outcome results
None listed