Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions

NCT04679701 | Completed DMC

• 1 other identifier: 20190425
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Transtibial Amputees

Outcome Measures

Primary Outcomes (1)

• 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

  1-2 months

Secondary Outcomes (2)

• Amputee Mobility Predictor

  1-2 months

• The L-test

  1-2 months

Study Arms (1)

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.

Device: Amparo Confidence Socket

Interventions

Amparo Confidence Socket DEVICE

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.

Recruited Amputees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

recruited from primary care clinic of APDK and the Cure respectively

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amparo GmbH: lead
• GDI Hub: collaborator
• AT 2030: collaborator

Study Sites (2)

AIC CURE International Hospital Kenya

Kijabe, Kenya

Location

Association for the Physically Disabled of Kenya (APDK)

Mombasa, 80100, Kenya

Location

Study Officials

• Giulia Barbareschi, PhD

  Researcher GDI hub

  PRINCIPAL INVESTIGATOR

• Catherine Holloway

  Cofounder GDI Hub, Associate Professor UCL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: July 8, 2019
• Primary Completion: March 12, 2020
• Study Completion: November 30, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)