Identify the Prosthesis Users' Necessities Concerning Their Devices.

Upper Limb Amputation at the Hand Clinical Trial

Official title:

Identify the Prosthesis Users' Necessities Concerning Their Devices.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06128135
• Other study ID #: 202310261600
• Status: Enrolling by invitation
• Start date: February 2024
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Federal University of Espirito Santo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Upper Limb Amputation at the Hand

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Reabilitação Física do Espírito Santo	Vila Velha	Espirito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Espirito Santo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices		1 hour