Identify the Prosthesis Users' Necessities Concerning Their Devices.
Conditions: Upper Limb Amputation at the Hand
Sponsor: Federal University of Espirito Santo

 
 
 
 
Identify the prosthesis users' 
necessities concerning their 
devices. 
VITÓRIA, BRASIL 
6 DE NOVEMBRO 2023 

 
 
Original 
Original Primary Outcome 
Measures  ICMJE 
Number of patients that have an unconformity with the weight of the 
device and which functional characteristics they would improve their 
devices s concerning their devices.  
Current Secondary Outcome 
Measures  ICMJE  
- 
Brief Summary (5000 Ch) 
Despite many advances in prosthesis development, there are still some 
areas that need to be improved. One of them is the weight of the devices 
which could cause muscular fatigue in long-term use of the prosthesis 
and even abandonment. This study aims to identify the desired 
improvements in prosthetic devices from the perspective of the users, 
therapists, and relatives. That would be done through two kinds of 
questionnaires about technology acceptance.  
Detailed Description (32000 
Ch) 
The World Health Organization (WHO) estimates that around 1.3 billion 
people experience significant disability. One of the actual challenges is 
facilitating and breaking the barriers of persons with disabilities. 
Assistance technology supports inclusion and participation, principally 
for people with disabilities.  
 
In Brazil, the DATASUS estimated that around 57802 amputations (one 
kind of disability) were performed in 2022. Prostheses are assistive 
devices that aim to mitigate the psychological impact of missing a 
member and help in activities of daily life (ADL). One kind of prosthesis 
is electrically powered, which uses electrical components to actuate the 
device and is commonly controlled by body signals such as surface 
electromyography (sEMG). Despite many advances in prosthesis 
development, some areas need to be improved such as weight, size, 
ergonomic design, etc. of the devices which could cause muscular 
fatigue in long-term use of the prosthesis and even abandonment. 
 
This study aims to identify the aspects that cause major discomfort in 
upper limb prosthesis users. Also, recognize in which activities of daily 
life, the prosthesis is involved. That information will be used to improve 
the design of an upper limb prosthesis. 
 
Study Type  ICMJE 
Observational, qualitative-quantitative study 
Study Phase  ICMJE 
Waiting for the approval to contact the prosthesis users 
Study Design  ICMJE 
The study is grounded on a non-invasive protocol, which investigates 
the necessities in the design of the upper limb prosthesis from the users', 
relatives’, and therapist's perspectives. 
Condition  ICMJE 
Upper limb amputees 
Intervention  ICMJE 
For the execution, three kinds of questionnaires about technology 
acceptance will be used. In the first questionnaire, which is for prosthesis 
users, there will be 15 questions to identify what kind of activities the 
person uses the prosthesis, how much is the use time and what is the 
main problem with the device. In the second and third questionnaires, 

 
which are for the therapist and relatives respectively, there will be 
between 8 and 9 questions to analyze which device characteristics, they 
think that cause major discomfort during the use and could be improved. 
 
Study Arms  ICMJE 
Arm 
Description 
Prosthesis 
Users 
30 participants, aged between 18 and 60, will be 
part of the study. It is necessary that the users have 
at least 6 months of experience using upper limb 
prostheses.  
Therapists 
10 therapists that have experience working with 
prostheses.     
Relatives 
30 of the prosthesis users’ relatives who live with 
the person and see the daily difficulties of using 
the device,  

 
Publications * 
 

 
Recruitment Information 
Recruitment Status  ICMJE 
Enrolling by invitation 
Actual Enrollment  ICMJE 
Participants will be selected from a predetermined population 
Original Actual 
Enrollment  ICMJE 
 
Actual Study Completion 
Date  ICMJE 
September 2024 
Actual Primary Completion 
Date 
September 2024 
Eligibility Criteria  ICMJE 
Prosthesis users with at least 6 months of device use. 
A therapist with experience in working with amputees. 
Relatives of the prosthesis users.  
Sex/Gender  ICMJE 
Mixed 
Ages  ICMJE 
18 to 60 years 
Accepts Healthy 
Volunteers  ICMJE 
- 
Contacts  ICMJE 
Laura Vanesa De Arco Barraza