Redesign, Implementation and Evaluation of the Effectiveness of the Aktio Myoelectric Prosthesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Universidad de Antioquia
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Functional status
Study Overview
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.
Detailed Description
Methodology and work plan of the pre-commercial validation process The methodology for the redesign of the transradial myoelectric prosthesis will seek to add value to the current design, by increasing the value perceived by the buyer by providing additional attributes to the current ones. The methodology will be divided into five main phases that go from the clarification of the objectives that are expected to be satisfied with the design, to the creation and evaluation of a functional prototype that has been improved after carrying out performance tests, and carrying out an evaluation. of effectiveness, in addition to a parallel phase to all that includes the financial analysis. The details of each of the phases are found below.
Conceptual design During this phase, we will seek to define the concept on which the redesign of the transradial prosthesis will be developed based on the Cross Design Method. Initially, a complete and clear approach must be made of the objectives that the prosthesis must satisfy through the clarification of objectives. Then, we will continue with the establishment of functions. Starting from the identification of the level of generality or detail at which to work, the functions and limits of the problem to be solved will be defined, establishing the specific functions that the prosthesis must satisfy, regardless of the physical components that could be used.
Subsequently, the requirements will be set, where the performance specification of the prosthesis will be defined, which will allow evaluating that the proposed solutions are within acceptable limits. In addition, the determination of characteristics will be elaborated, where the desirable attributes of the new product will be compared - from the customer's point of view - with the previously defined engineering requirements. This comparison will be made through the deployment of the quality function, which implies interviews or surveys with possible users and experts on the subject, group sessions, search for the state of the art, among others.
Finally, the generation of alternatives and their evaluation will be carried out. The generation of alternatives is based on the morphological diagram method, which presents the full range of elements, components or secondary solutions that can be combined to form different solutions, from which the alternative designs will be defined. During the evaluation of alternatives, the different alternative designs will be evaluated according to the previously defined requirements and objectives.
For these activities, there will be a group of participants with transradial amputation who agree to enter the study. In the session, the priorities and preferences of patients regarding the use of prostheses and the needs that these should cover will be qualitatively evaluated. It will investigate aspects such as usability, comfort, adaptation, strength, mobility, performance in activities of daily living and quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with bilateral upper limb amputation.
- •Patients with skin or soft tissue injuries that contraindicate the use of prostheses.
Arms & Interventions
Aktio
Use of the prosthesis for 2 weeks, after a 3-session training
Intervention: Aktio prosthesis (Device)
Control
Non-use of the prosthesis
Outcomes
Primary Outcomes
Functional status
Time Frame: 2 weeks after training with the prostheses in the intervention group
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.
Secondary Outcomes
- Satisfaction with prosthesis(2 weeks after training with the prostheses in the intervention group)
- Observed performance(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)