AmputationASSISTNCT05196100
Acceptability of an Interim Socket System
A study testing Amparo confidence socket in people with Amputation, run by University of Hull at 2 sites in United Kingdom.
Trial summary
This study will explore the acceptability of an interim socket system to new patients with a below-knee amputation and also to NHS healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Amparo confidence socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Oct 2021to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- New transtibial amputation within the last 6 months
- Deemed ready to cast for a prosthesis by the clinical team as per usual care at the prosthetic centre
- Able to understand written English and provide informed consent
Who cannot join
- Participants under the age of 18
- Participants with an ankle disarticulation, Knee disarticulation or transfemoral amputation
- Body mass > 125 kg with a distal circumference of 23-34 cm (small socket)
- Body mass > 150 kg with a distal circumference of 30-45 cm (large socket)
- Residual limb longer than 27 cm
- Severe upper limb dysfunction (due to strength requirements to don the liner)
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- Severe visual requirements (that would restrict the person's ability to monitor their residual limb)
- Contraindication to be fit for a prosthetic socket
- Recent cerebrovascular event (i.e., stroke, haemorrhage, brain injury)
- Disease affecting their memory
- Unwilling to trial the confidence socket system
- Unable to tolerate wearing a prosthetic liner due to excess sweating/ allergic reaction or other reasons
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Dorset NHS Foundation Trust
Bournemouth, BH7 7DW
Portsmouth Hospitals University NHS Trust
Portsmouth, PO3 6AD
About this study
Official title: Acceptability of an Interim Socket System in the Immediate Rehabilitation of People With a tranSTibial Amputation (ASSIST): A Pilot Study
This study will explore the acceptability of an interim socket system to new patients with a below-knee amputation and also to NHS healthcare providers.
Read the detailed description
After a transtibial amputation, post-operative swelling, followed by muscle wasting, can lead to residual limb volume changes during the first 12 months. Managing this volume change often involves many socket modifications and/or replacement sockets. These multiple re-casts can be burdensome for the patient and delay recovery as patients are unable to mobilise and progress in an ill-fitting socket, leading to increased health resource use and costs.
An alternative technology exists involving an interim (aka confidence) socket whereby thermoplastic material is moulded onto the patient's residual limb and a socket is produced in a single session. This material can then be heated and remoulded quickly and comfortably, so that the patient accommodates to a single socket that can be adjusted as required to volume changes.
The confidence socket system could make the casting and prosthetic fitting process more efficient and cost-effective and improve the speed of delivery of the interim prosthesis. Thus a patient could start gait re-training with their confidence socket earlier compared to the standard treatment of fitting a laminate or polypropylene socket.
The aim of this pilot study is to assess the acceptability of the confidence socket to NHS healthcare providers and their patients, during an initial 3-month prosthetic fitting period.
Amputee participants will be recruited from 2 NHS sites. They will receive standard pre-prosthetic physiotherapy treatment until their primary MDT appointment, when they will be cast for their first prosthesis using the confidence socket which will replace standard care with the usual socket. Prescription of prosthetic foot components will continue as per usual care. Once the confidence socket is complete the patient will begin treatment according to usual physiotherapy rehabilitation. Amputee participants will be interviewed about their experience of receiving treatment with the confidence socket.
Healthcare providers delivering the treatment will also be interviewed about their acceptability of the confidence socket within the NHS pathways.
- Conditions
- Amputation
- Being tested
- Amparo confidence socket
- Keywords
- transtibial, below-knee, prosthesis, socket, residual limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amparo confidence socketDevice
Confidence socket involves thermoplastic material being moulded onto the patient's residual limb and a socket is produced in a single session. The socket can be remoulded to adjust to changes in residual limb volume.
| Study group | Role | What they receive |
|---|---|---|
| Confidence socket | Experimental | Participants to receive a confidence socket system Receives: Device: Amparo confidence socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Socket comfort score
Patient-reported socket comfort
Measured: Up to 6 months
Secondary outcomes (4)
Change in EQ-5D-5L
Health related quality of life
Measured: Up to 6 months
Change in Locomotor Capabilities Index (LCI-5)
LCI-5 with prosthesis
Measured: Up to 6 months
Change in Activities Balance Confidence-UK (ABC-UK)
Balance confidence
Measured: Up to 6 months
Change in L-test
Functional timed up and go L-test
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start12 Oct 2021
- Primary completion28 Nov 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust, University of Southampton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196100
- Sponsor's protocol ID
- RS149-291816-NV
- Acronym
- ASSIST
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of an Interim Socket System in the Immediate Rehabilitation of People With a tranSTibial Amputation (ASSIST): A Pilot Study
- ClinicalTrials.gov ID
- NCT05196100
- Acronym / sponsor ID
- ASSIST / RS149-291816-NV
- Conditions
- Amputation
- Keywords
- transtibial, below-knee, prosthesis, socket, residual limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust, University of Southampton
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the acceptability of an interim socket system to new patients with a below-knee amputation and also to NHS healthcare providers.
Detailed description
After a transtibial amputation, post-operative swelling, followed by muscle wasting, can lead to residual limb volume changes during the first 12 months. Managing this volume change often involves many socket modifications and/or replacement sockets. These multiple re-casts can be burdensome for the patient and delay recovery as patients are unable to mobilise and progress in an ill-fitting socket, leading to increased health resource use and costs.
An alternative technology exists involving an interim (aka confidence) socket whereby thermoplastic material is moulded onto the patient's residual limb and a socket is produced in a single session. This material can then be heated and remoulded quickly and comfortably, so that the patient accommodates to a single socket that can be adjusted as required to volume changes.
The confidence socket system could make the casting and prosthetic fitting process more efficient and cost-effective and improve the speed of delivery of the interim prosthesis. Thus a patient could start gait re-training with their confidence socket earlier compared to the standard treatment of fitting a laminate or polypropylene socket.
The aim of this pilot study is to assess the acceptability of the confidence socket to NHS healthcare providers and their patients, during an initial 3-month prosthetic fitting period.
Amputee participants will be recruited from 2 NHS sites. They will receive standard pre-prosthetic physiotherapy treatment until their primary MDT appointment, when they will be cast for their first prosthesis using the confidence socket which will replace standard care with the usual socket. Prescription of prosthetic foot components will continue as per usual care. Once the confidence socket is complete the patient will begin treatment according to usual physiotherapy rehabilitation. Amputee participants will be interviewed about their experience of receiving treatment with the confidence socket.
Healthcare providers delivering the treatment will also be interviewed about their acceptability of the confidence socket within the NHS pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confidence socket | Experimental | Device: Amparo confidence socketParticipants to receive a confidence socket system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 18
- New transtibial amputation within the last 6 months
- Deemed ready to cast for a prosthesis by the clinical team as per usual care at the prosthetic centre
- Able to understand written English and provide informed consent
Key exclusion criteria (12 listed)
- Participants under the age of 18
- Participants with an ankle disarticulation, Knee disarticulation or transfemoral amputation
- Body mass > 125 kg with a distal circumference of 23-34 cm (small socket)
- Body mass > 150 kg with a distal circumference of 30-45 cm (large socket)
- Residual limb longer than 27 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amparo confidence socketConfidence socket involves thermoplastic material being moulded onto the patient's residual limb and a socket is produced in a single session. The socket can be remoulded to adjust to changes in residual limb volume. | Device | Confidence socket |
Primary outcome
Change in Socket comfort score
Time frame: Up to 6 months
Patient-reported socket comfort
4 secondary outcomes
Change in EQ-5D-5L
Time frame: Up to 6 months
Change in Locomotor Capabilities Index (LCI-5)
Time frame: Up to 6 months
Change in Activities Balance Confidence-UK (ABC-UK)
Time frame: Up to 6 months
Change in L-test
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amparo confidence socket in people with Amputation, run by University of Hull at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Socket comfort score (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.