Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05510193 |
| Other study ID # |
2019-30970 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2022 |
| Est. completion date |
December 27, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Universidad de Antioquia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
Additionally, the participation of professionals involved in the rehabilitation of patients
with upper limb amputation will be sought, who will also be interviewed to define the
objectives and clinical aspects to be taken into account in the design of the prosthesis.
Likewise, both entities (Prótesis Avanzadas and the University of Antioquia) will keep the
deliverables of this design phase.
Materialization design This design phase follows the methodology established for Engineering
Design by Pahl and Beitz, and in it the design of the transradial myoelectric prosthesis is
developed from the concept defined in the previous phase and considering the technical and
economic criteria of the same. In addition, it must lead to the definitive design of the
prostheses, after verifying that the function, durability, production, assembly, operation
and costs of the design meet the specifications.
It is important to keep in mind that due to the complexity of materialization design (i.e.
some activities must be repeated when more information is available, changes made in one area
of the design may affect others, several actions must be carried out simultaneously),
particular problems that are found can generate deviations from what was planned. Therefore,
it is recommended to develop this phase starting from the most general to the most specific
and defining verification points to make corrections.
Both entities will retain the deliverables from this design phase. Detail design In this
phase of the design, it is expected to obtain the necessary documents to produce myoelectric
prostheses. In our specific case, since the Prosthetics Advanced production system is based
on 3D printing, the main documents will be the CAD files of the designed components, the list
of parts that includes both the commercial elements and the printed components, the assembly
drawing and the manual of use of the prosthesis. Both entities will retain the deliverables
from this design phase.
Pre-commercial evaluation As a final phase of the design, a prototype will be manufactured,
and performance tests will be carried out. Likewise, production tests will be carried out in
which problems with the creation of the prostheses are identified. Finally, with the results
of the tests, the design improvements will be developed, updating the necessary documents to
produce the prostheses and obtaining a prototype of the improved design. Once the design has
been defined, an effectiveness study will be carried out with patients with transradial
amputation.
Design of the effectiveness study A clinical trial with a randomized crossover design will be
carried out to define the moment of the intervention in twelve participants. This type of
design reduces the influence of confounding variables because subjects can act as their own
control in the trial and is ideal for evaluating interventions in chronic and stable
conditions, such as limb amputations.
The intervention will then be compared, that is, the use of the myoelectric prosthesis versus
the non-use of the prosthesis. It is assumed that there is no "carryover" effect as the
intervention (prosthesis) is expected to have the desired effect while in use and not have a
residual effect on function upon removal, therefore no washout period is required between
removal. the interventions.
Selection and sample size Sampling will be done for convenience and patients will be selected
from the physiatry, plastic surgery or orthopedics clinic of the participating institutions.
The number of patients was selected considering the costs of the design, the costs and time
required for the elaboration of the prostheses, the time required for effectiveness tests and
the resources available for the project.
Intervention and control Each prosthesis will be delivered by members of the design team and
a physical or occupational therapist, who will make the necessary adjustments for adaptation
and will train in its use during two sessions of 3 hours each. In the intervention group, the
patients will use the prosthesis for a period of two weeks and after this time they will be
scheduled for the application of the functioning, satisfaction and quality of life scales.
The patients assigned to the control group will be cited for the application of the
functioning and quality of life scales. The controls will be carried out without the use of
the prosthesis since this is the most common scenario in upper limb amputees and we want to
demonstrate that the use of prostheses is superior to "no treatment".
No washout period is required between periods as the intervention (prosthesis) is expected to
have the desired effect while in use and not have a residual effect upon removal. Blinding of
participants or investigators will not be possible due to the type of intervention and
outcome measurement.
Outcomes For this study, selected outcomes will be evaluated: functioning defined as
performance in daily activities, both self-reported and observed; satisfaction with the
prosthesis and health-related quality of life. Recently, the Working Group on Upper Extremity
Prosthetic Outcome Measures (ULPOM) recommended the use of the World Health Organization
International Classification of Functioning, Disability and Health (ICF) as the ideal
framework for selecting instruments and outcomes, and highlighted the importance of selecting
assessment tools that take into account each of the important elements of the ICF, including
body structures and functions (prosthesis performance), activity (performing tasks), and
participation (use of the device). prosthetics in real life situations).
Data collection plan To obtain the data of the possible participants, patients who meet the
inclusion criteria will be contacted, invitations to be part of the study will be sent, with
a summary of the study, and visits will be planned after making appointments with those who
have agreed to participate. During the visits, compliance with the inclusion criteria will be
confirmed, the objectives and methodology of the project will be explained, and informed
consent will be obtained. The data will be taken from primary sources through the application
of instruments completed by the participant and performance instruments supervised by one of
the researchers. The random allocation will be made using computer-generated codes, in sealed
and opaque envelopes. Two measurements of the outcomes will be made, with and without the use
of prostheses, separated by a period of 2 weeks. One person will be responsible for data
collection and should verify the quality of the records and the presence of missing data
before leaving the participant's side. The principal investigator will review the quality of
the records and the presence of missing data that would require recontacting the participant
in person or by phone.
The data obtained through the application of the instruments will be digitized by one of the
researchers and reviewed by the principal investigator to control the quality of the data.
Everything will be recorded in a database in MS Access®.
Ethical considerations According to Resolution 8430 of 1993, which establishes the
scientific, technical, and administrative standards for health research, it is considered
low-risk research. Approval from a Human Research Bioethics Committee will be sought.
Research involving human beings must be governed by three basic ethical principles. The
principle of respect for people, which refers to autonomy in participating in a study; it is
guaranteed through informed consent and respect for autonomy, clarifying that participation
is voluntary and can be stopped at any time during the study. The principle of beneficence
refers to the effort to promote the well-being of the research subject, seeking to achieve
the maximum benefit with the minimum risk and harm. The principle of justice is related to
the equitable selection of participants and equitable access to risks and benefits.
The research team is committed to complying with the standards of good clinical practice in
research. We will provide detailed information to each participant about the purpose and
importance of the study and request informed consent from each one. The research team will be
responsible for the confidentiality of patient data. The information will be encrypted and
kept in custody. Upon completion of the investigation, the team agrees to disclose the
results.
It should be noted that prostheses are classified as non-invasive medical devices and that
the Prótesis Avanzadas company has experience in the production of 3D-printed prostheses for
upper limbs.
