Identify the Prosthesis Users' Necessities Concerning Their Devices.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Upper Limb Amputation at the Hand
• Intervention / Treatment: Other: Technology acceptance questionnaire for prostheses users.; Other: Technology acceptance questionnaire for therapists; Other: Technology acceptance questionnaire for relatives of prostheses users.

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Brazil
  • Espirito Santo
    • Vila Velha, Espirito Santo, Brazil, 29101030
      • Centro de Reabilitação Física do Espírito Santo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prosthesis 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.	Other: Technology acceptance questionnaire for prostheses users.; One questionnaire, which is for prosthesis users, where 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.
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.	Other: Technology acceptance questionnaire for therapists; One questionnaire, where there will be between 9 questions to analyze which device characteristics, they think cause major discomfort during the use and could be improved.
Relatives; 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.	Other: Technology acceptance questionnaire for relatives of prostheses users.; One questionnaire, where there will be between 8 questions to analyze which device characteristics, they think cause major discomfort during the use and could be improved.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Espirito Santo

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202310261600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No