Identify the Prosthesis Users' Necessities Concerning Their Devices.

NCT06128135 | Unknown

• 1 other identifier: 202310261600
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Amputation at the Hand

Outcome Measures

Primary Outcomes (1)

• Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices

  1 hour

Study Arms (3)

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.

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

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.

Interventions

Technology acceptance questionnaire for prostheses users. OTHER

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.

Prosthesis Users

Technology acceptance questionnaire for relatives of prostheses users. OTHER

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.

Relatives

Technology acceptance questionnaire for therapists OTHER

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.

Therapists

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Federal University of Espirito Santo: lead

Study Sites (1)

Centro de Reabilitação Física do Espírito Santo

Vila Velha, Espírito Santo, 29101030, Brazil

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 13, 2023
• Study Start: February 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

BR (1)