Identify the Prosthesis Users' Necessities Concerning Their Devices.

• Conditions: Upper Limb Amputation at the Hand
• Interventions: Other: Technology acceptance questionnaire for therapists; Other: Technology acceptance questionnaire for prostheses users.; Other: Technology acceptance questionnaire for relatives of prostheses users.

• Registration Number: NCT06128135
• Lead Sponsor: Federal University of Espirito Santo

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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Study Start: 2024-02
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapists	Technology acceptance questionnaire for therapists	10 therapists that have experience working with prostheses. They will be asked a 9-question survey about upper limb prostheses that they usually handle.
Prosthesis Users	Technology acceptance questionnaire for prostheses users.	30 participants, aged between 18 and 60, will be part of the study. The users must have at least 6 months of experience using upper limb prostheses. They will be asked a 15-question survey about their upper limb prostheses.
Relatives	Technology acceptance questionnaire for relatives of prostheses users.	30 of the prosthesis users' relatives who live with the person and see the daily difficulties of using the device. They will be asked a 9-question survey about the device that their relatives costume to use.

Primary Outcome Measures

Name	Time	Method
Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices	1 hour

Trial Locations

Locations (1)

Centro de Reabilitação Física do Espírito Santo; 🇧🇷 Vila Velha, Espirito Santo, Brazil