Clinical trial NCT04679701: Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transtibial Amputees
Lead sponsor: Amparo GmbH
Sponsor class: INDUSTRY
Collaborators: name: GDI Hub
name: AT 2030
First posted: 2020-12-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: recruited from primary care clinic of APDK and the Cure respectively

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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)

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Exclusion Criteria:

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)

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Primary outcomes:
measure: Trinity amputation and prosthesis scale
timeFrame: 1-2 months
Secondary outcomes:
measure: Amputee Mobility Predictor
timeFrame: 1-2 months
measure: The L-test
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Kijabe
country: Kenya
facility: AIC CURE International Hospital Kenya
city: Mombasa
country: Kenya
facility: Association for the Physically Disabled of Kenya (APDK)
Study officials:
affiliation: Researcher GDI hub
name: Giulia Barbareschi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cofounder GDI Hub, Associate Professor UCL
name: Catherine Holloway
role: STUDY_DIRECTOR
References: