Transtibial AmputeesNCT04679701
Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions
An observational study of Transtibial Amputees, run by Amparo GmbH at 2 sites in Kenya.
Trial summary
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transtibial Amputees
- What is being tested?
- Amparo Confidence Socket
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 2 sitesKenya
- Study dates
- 8 Jul 2019to 30 Nov 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: recruited from primary care clinic of APDK and the Cure respectively
Who may be able to join
- Below-Knee amputees 18 years of or older Individuals who would normally receive prosthetic care from the respective organization Minimum of 4 weeks after amputation Able to read and communicate in English User must be able to use a passive valve suspension system with a knee sleeve (Donning the LLP with suspension system require moderate level of hand strength and dexterity)
- -
Who cannot join
- Users who have a known complication e.g. infection, open wounds, etc… Users who weigh more than 125kg (the max usage weight for the product) Users' residual limb cannot be longer than 25cm (MPT to stump end measurement) Users' residual limb cannot have distal circumference larger than 45cm (measured circumference with liner 4cm from end of stump)
- -
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
AIC CURE International Hospital Kenya
Kijabe
Association for the Physically Disabled of Kenya (APDK)
Mombasa, 80100
About this study
Official title: Research Protocol for Using Confidence Socket Technology in Developing Regions: An Exploratory Study of New Techniques and Materials for Lower-limb Prosthetic Sockets
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Survey information will be collected along the way to assess how well the product is adapted by CPOs and patients.
Read the detailed description
Objective:
The objective of the trial is to ascertain the benefits and the implications of using the Amparo socket technology within the context of two pre-existing prosthetic services in Eastern Africa.
Design:
The trial is a phase one, exploratory single group trial. 4 Certified Prosthetist Orthotists (CPOs) will be trained to use the Amparo socket technology. Over a 7-month period, 40 lower limb amputees will be recruited to participate in the study where they will be fitted with the Amparo socket technology. Follow-up after one month of using the product will help build understanding their experience with the new prosthetic leg.
There will be a beginning and end surveys and interviews with each of the 4 CPOs.
Video and written observations will be taken of both the traditional socket making method and the Confidence Socket method for comparison.
Amputee participant surveys and assessments will be collected at each fitting, and follow-up visit.
Intervention:
The intervention for the study is to introduce a new fitting method and product for lower limb prosthetic, namely the Amparo Confidence Socket consisting of the socket and liner components. All other components of the prosthesis should remain the same as what is typically used in the respective organizations.
Population:
Professionals who craft prosthesis for amputees (CPOs) and Below-knee amputees who are able to and desire to use a prosthesis who reside in Kenya.
Outcome Measures:
CPO comfort level, perceived competence, and acceptance of the Confidence Socket Technology.
Patient quality of life measure Patient mobility measures Comparative task model between traditional method and the Amparo socket technology
Duration and follow-up:
The trial will last approximately 7 months. Starting from the first introduction of the new technology until the final interview with each CPO has been completed.
- Conditions
- Transtibial Amputees
- Being tested
- Amparo Confidence Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amparo Confidence SocketDevice
The Amparo Confidence Socket technology takes a different approach by starting with a prefabricated socket (https://www.amparo.world/confidence-socket-en). The socket is made from a moldable thermoplastic and has the attachment point pre-assembled. This prefabricated socket is essentially an "off-the-shelf" product that can be heated, then molded directly to the patient's residual limb. This removes many of the intermediate steps in traditional socket fabrication. The product's molding temperature is between 60-70 ˚C but the insulation of a silicone liner between the plastic and limb ensures safe temperatures for the patient. This process is currently used in several workshops in Europe and with approximately 50 patients currently using the product. In general, it has been shown to be safe and effective in creating below-knee prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Recruited Amputees | The amputee participants will be recruited over the course of 6 months. Once a patient is recruited and has given consent, they will be fitted with a prosthesis using the Confidence Socket technology and be administered an initial survey. A follow-up meeting for one month after the fitting is scheduled. At the follow-up appointment adjustments to the prosthesis are made as needed and the patient is administered another survey. Receives: Device: Amparo Confidence Socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trinity amputation and prosthesis scale
a psychometric assessment designed for lower limb amputees, will be used to assess quality of life, satisfaction, and adjustment level to using an LLP
Measured: 1-2 months
Secondary outcomes (2)
Amputee Mobility Predictor
an instrument that will be used to assess amputee's ability to ambulate
Measured: 1-2 months
The L-test
a variation of the "up \& go" test designed specifically for lower-limb amputees
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start8 Jul 2019
- Primary completion12 Mar 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputeesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amparo GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GDI Hub, AT 2030
- Responsible party
- Sponsor
- Investigators
- Giulia Barbareschi, PhD, Principal investigator, Researcher GDI hubCatherine Holloway, Study director, Cofounder GDI Hub, Associate Professor UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679701
- Sponsor's protocol ID
- 20190425
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Protocol for Using Confidence Socket Technology in Developing Regions: An Exploratory Study of New Techniques and Materials for Lower-limb Prosthetic Sockets
- ClinicalTrials.gov ID
- NCT04679701
- Acronym / sponsor ID
- 20190425
- Conditions
- Transtibial Amputees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Amparo GmbHIndustry (pharma, biotech, devices)
- Collaborators
- GDI Hub, AT 2030
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 22 Dec 2020 (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.
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Survey information will be collected along the way to assess how well the product is adapted by CPOs and patients.
Detailed description
Objective:
The objective of the trial is to ascertain the benefits and the implications of using the Amparo socket technology within the context of two pre-existing prosthetic services in Eastern Africa.
Design:
The trial is a phase one, exploratory single group trial. 4 Certified Prosthetist Orthotists (CPOs) will be trained to use the Amparo socket technology. Over a 7-month period, 40 lower limb amputees will be recruited to participate in the study where they will be fitted with the Amparo socket technology. Follow-up after one month of using the product will help build understanding their experience with the new prosthetic leg.
There will be a beginning and end surveys and interviews with each of the 4 CPOs.
Video and written observations will be taken of both the traditional socket making method and the Confidence Socket method for comparison.
Amputee participant surveys and assessments will be collected at each fitting, and follow-up visit.
Intervention:
The intervention for the study is to introduce a new fitting method and product for lower limb prosthetic, namely the Amparo Confidence Socket consisting of the socket and liner components. All other components of the prosthesis should remain the same as what is typically used in the respective organizations.
Population:
Professionals who craft prosthesis for amputees (CPOs) and Below-knee amputees who are able to and desire to use a prosthesis who reside in Kenya.
Outcome Measures:
CPO comfort level, perceived competence, and acceptance of the Confidence Socket Technology.
Patient quality of life measure Patient mobility measures Comparative task model between traditional method and the Amparo socket technology
Duration and follow-up:
The trial will last approximately 7 months. Starting from the first introduction of the new technology until the final interview with each CPO has been completed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruited Amputees | – | Device: Amparo Confidence SocketThe amputee participants will be recruited over the course of 6 months. Once a patient is recruited and has given consent, they will be fitted with a prosthesis using the Confidence Socket technology and be administered an initial survey. A follow-up meeting for one month after the fitting is scheduled. At the follow-up appointment adjustments to the prosthesis are made as needed and the patient is administered another survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- recruited from primary care clinic of APDK and the Cure respectively
Key inclusion criteria (2 listed)
- Below-Knee amputees 18 years of or older Individuals who would normally receive prosthetic care from the respective organization Minimum of 4 weeks after amputation Able to read and communicate in English User must be able to use a passive valve suspension system with a knee sleeve (Donning the LLP with suspension system require moderate level of hand strength and dexterity)
- -
Key exclusion criteria (2 listed)
- Users who have a known complication e.g. infection, open wounds, etc… Users who weigh more than 125kg (the max usage weight for the product) Users' residual limb cannot be longer than 25cm (MPT to stump end measurement) Users' residual limb cannot have distal circumference larger than 45cm (measured circumference with liner 4cm from end of stump)
- -
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 SocketThe Amparo Confidence Socket technology takes a different approach by starting with a prefabricated socket (https://www.amparo.world/confidence-socket-en). The socket is made from a moldable thermoplastic and has the attachment point pre-assembled. This prefabricated socket is essentially an "off-the-shelf" product that can be heated, then molded directly to the patient's residual limb. This removes many of the intermediate steps in traditional socket fabrication. The product's molding temperature is between 60-70 ˚C but the insulation of a silicone liner between the plastic and limb ensures safe temperatures for the patient. This process is currently used in several workshops in Europe and with approximately 50 patients currently using the product. In general, it has been shown to be safe and effective in creating below-knee prosthesis. | Device | Recruited Amputees |
Primary outcome
Trinity amputation and prosthesis scale
Time frame: 1-2 months
a psychometric assessment designed for lower limb amputees, will be used to assess quality of life, satisfaction, and adjustment level to using an LLP
2 secondary outcomes
Amputee Mobility Predictor
Time frame: 1-2 months
The L-test
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Transtibial Amputees
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Recruiting
Reliability and Validity of Continuous Inter-limb Stability
Amputation, Lower Limb
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
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.
Giulia Barbareschi, PhD principal investigator
Researcher GDI hub
Catherine Holloway study director
Cofounder GDI Hub, Associate Professor UCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transtibial Amputees, run by Amparo GmbH at 2 sites in Kenya.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Dec 2020. 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 Kenya. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trinity amputation and prosthesis scale (time frame: 1-2 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 22 Dec 2020.