NCT05510193

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

Status unknown NA Last updated 27 December 2023

What this trial tests

NA trial testing Aktio prosthesis in Upper Limb Amputation Below Elbow (Injury) in 10 participants. Status unknown.

Timeline

22 June 2022

Primary endpoint
30 September 2023

27 December 2023

Quick facts

Lead sponsor	Universidad de Antioquia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	22 June 2022
Primary completion	30 September 2023
Estimated completion	27 December 2023
Sites	2 locations across Colombia

Drugs / interventions tested

• Aktio prosthesis

Conditions studied

• Upper Limb Amputation Below Elbow (Injury) — all drugs for Upper Limb Amputation Below Elbow (Injury) →
• Prosthesis User — all drugs for Prosthesis User →
• Satisfaction, Patient — all drugs for Satisfaction, Patient →

Sponsor

Universidad de Antioquia — full company profile →

Who can join

18 and older, any sex, with Upper Limb Amputation Below Elbow (Injury) or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.