MedTrace Logo

Redesign, Implementation and Evaluation of the Effectiveness of the Aktio Myoelectric Prosthesis

NCT05510193 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-12-27

No results posted yet for this study

Summary

In Latin America, Colombia ranks fourth in countries with the highest number of people with disabilities (6.4%), 80% of whom live in low socioeconomic strata, have little access to education and high unemployment rates. Of these nearly 3 million people with this condition, an estimated 11,476 need upper limb prostheses, 12% of whom have transradial or below-elbow amputation. Although many of the functions that have been lost by amputation can be recovered with a prosthesis, few people in Colombia use these devices. This is because, currently, only aesthetic and mechanical options are found, and the most advanced options, such as myoelectric ones, are manufactured in other countries, have very high prices and are not designed according to local needs. The only option manufactured at the national level is the one developed by Protesis Avanzadas S.A.S., but it still has aspects to improve that would lead it to better adapt to the needs of Colombian users.

All of the above shows the evident need for the country to generate products that can help this population. The objective of this project is then to redesign, implement and evaluate the effectiveness of a good quality transradial myoelectric prosthesis, focused on the Colombian amputee population and improving acceptance rates. For the design phase of the study, a group made up of health professionals and patients with transradial amputation will be included to evaluate the preferences and priorities of their prosthesis. For pre-commercial validation, an effectiveness study will be carried out by means of a randomized crossover clinical trial with 12 participants in which the functioning and quality of life of the user with and without the prosthesis and satisfaction with it will be analyzed using methods of Bayesian statistics. This study is expected not only to improve the quality of life of people with transradial amputation and their families, but also to provide a functional option for the health system.

Conditions

  • Upper Limb Amputation Below Elbow (Injury)
  • Prosthesis User
  • Satisfaction, Patient

Interventions

DEVICE

Aktio prosthesis

Transradial myoelectric prosthesis

Sponsors & Collaborators

  • Hospital San Vicente Fundación

    collaborator OTHER

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Juan D Lemos · Universidad de Antioquia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-09-30
Completion
2023-12-27

Countries

  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510193 on ClinicalTrials.gov