Upper Limb Amputation at the HandNCT06128135
Identify the Prosthesis Users' Necessities Concerning Their Devices.
An observational study of Upper Limb Amputation at the Hand, run by Federal University of Espirito Santo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Limb Amputation at the Hand
- What is being tested?
- Technology acceptance questionnaire for prostheses users., Technology acceptance questionnaire for relatives of prostheses users. and Technology acceptance questionnaire for therapists
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Inhabitants of Brazil, from the state of Espírito Santo. The participants are associated with the Crefes rehabilitation center.
Who may be able to join
- Prosthesis users with at least 6 months of device use.
- Therapists with experience in working with amputees.
- Relatives of the prosthesis users.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Reabilitação Física do Espírito Santo
Vila Velha, Espírito Santo, 29101030
About this study
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.
Read the 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.
- Conditions
- Upper Limb Amputation at the Hand
- Being tested
- Technology acceptance questionnaire for prostheses users., Technology acceptance questionnaire for relatives of prostheses users., Technology acceptance questionnaire for therapists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Technology acceptance questionnaire for therapistsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Technology acceptance questionnaire for relatives of prostheses users. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startFeb 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation at the HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128135
- Sponsor's protocol ID
- 202310261600
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify the Prosthesis Users' Necessities Concerning Their Devices.
- ClinicalTrials.gov ID
- NCT06128135
- Acronym / sponsor ID
- 202310261600
- Conditions
- Upper Limb Amputation at the Hand
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prosthesis Users | – | Other: 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. |
| Therapists | – | Other: Technology acceptance questionnaire for therapists10 therapists that have experience working with prostheses. They will be asked a 9-question survey about upper limb prostheses that they usually handle. |
| Relatives | – | Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Inhabitants of Brazil, from the state of Espírito Santo. The participants are associated with the Crefes rehabilitation center.
Key inclusion criteria (3 listed)
- Prosthesis users with at least 6 months of device use.
- Therapists with experience in working with amputees.
- Relatives of the prosthesis users.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Prosthesis Users |
| 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. | Other | Relatives |
| Technology acceptance questionnaire for therapistsOne 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. | Other | Therapists |
Primary outcome
Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Amputation at the Hand, run by Federal University of Espirito Santo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.