Clinical trial NCT06128135: Identify the Prosthesis Users' Necessities Concerning Their Devices.
Official title: Identify the Prosthesis Users' Necessities Concerning Their Devices.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Upper Limb Amputation at the Hand
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants of Brazil, from the state of Espírito Santo. The participants are associated with the Crefes rehabilitation center.

Brief summary: 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: 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.

For the execution, two 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 in 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 questionnaire, which is for the therapist and relatives, there will be 9 questions to analyze which device characteristics cause major discomfort during the use and could be improved.

Eligibility criteria: Inclusion Criteria:

* Prosthesis users with at least 6 months of device use.
* Therapists with experience in working with amputees.
* Relatives of the prosthesis users.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vila Velha
country: Brazil
facility: Centro de Reabilitação Física do Espírito Santo
state: Espirito Santo
Study officials:
References: