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

NCT05510193 | Unknown

• 1 other identifier: 2019-30970
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Myoelectric prosthesis; 3D printing

Outcome Measures

Primary Outcomes (1)

• Functional status

  Auto-reported functioning. Measured with the Orthotics and Prosthetics Users Survey - Upper extremity Functional status (OPUS - UEFS). It is an instrument to report the difficulty or ease in the execution of 23 tasks of daily life and self-care. Tasks are rated on a 1-5 point scale (very easy to unable to do the activity), regardless of how the activities are performed (with or without a prosthesis). Scores range from 0 to 100, with higher scores indicating more difficulty in performing activities.

  2 weeks after training with the prostheses in the intervention group

Secondary Outcomes (3)

• Observed performance

  2 weeks after training with the prostheses in the intervention group

• Satisfaction with prosthesis

  2 weeks after training with the prostheses in the intervention group

• Quality of life related to health and prosthesis use

  2 weeks after training with the prostheses in the intervention group

Study Arms (2)

Aktio

EXPERIMENTAL

Use of the prosthesis for 2 weeks, after a 3-session training

Device: Aktio prosthesis

Control

NO INTERVENTION

Non-use of the prosthesis

Interventions

Aktio prosthesis DEVICE

Transradial myoelectric prosthesis

Aktio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who live in Medellín or the metropolitan area and can travel to the place of evaluation.
• Patients who are able to understand and follow orders.

You may not qualify if:

• Patients with bilateral upper limb amputation.
• Patients with skin or soft tissue injuries that contraindicate the use of prostheses.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Hospital San Vicente Fundación: collaborator

Study Sites (2)

Hospital San Vicente Fundación

Medellín, Antioquia, 050022, Colombia

Location

Prótesis Avanzadas S.A.S

Medellín, Antioquia, 050022, Colombia

Location

MeSH Terms

Conditions

Wounds and Injuries; Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Juan D Lemos

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: August 22, 2022
• Study Start: June 22, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 27, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available once it is finished collecting in the 12 participants. There will be no time limit for its availability.
• Access Criteria: They will be shared at the request of the interested parties, who establish a clear objective for the use of the data in the request.

Locations

CO (2)