Assistive TechnologyNCT06585280
Assistive Device Satisfaction
An observational study of Assistive Technology and Orthosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Assistive devices are of critical importance for the independence and participation of disabled individuals in society and there is an increasing interest in them today. When the literature is examined, it is seen that there are few studies evaluating the use of orthotic and prosthetic assistive devices in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assistive Technology, Orthosis, Prosthesis
- How many people
- 262 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive devices will be included in the study on a voluntary basis.
Who may be able to join
- Female/male individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive device
- No cognitive and/or psychological problems
- Individuals without a diagnosis of neurological disease
Who cannot join
- Diagnosed with a vestibular system disorder
- Diagnosed with a sensorimotor system disorder
- Having an autoimmune disorder
- Individuals with a history of hospitalization for more than three days in the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Comparison of Satisfaction Levels Among Users of Assistive Devices - a Mixed-methods Study
Assistive devices are of critical importance for the independence and participation of disabled individuals in society and there is an increasing interest in them today. When the literature is examined, it is seen that there are few studies evaluating the use of orthotic and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the satisfaction of individuals using assistive devices in a multifaceted way.
Read the detailed description
Assistive devices are medical devices designed to support the individuals functions and increase their activities. Assistive devices are of critical importance for the independence and participation of disabled individuals in society and are of increasing interest today. The use of assistive devices is a process consisting of different steps to increase the individuals participation in daily life activities.
Although assistive devices cannot completely eliminate disability, they can increase independence by reducing negative effects. There are many problems encountered in the selection of assistive devices. The problems encountered include the cost of the assistive device, the necessary application training, service delivery, environmental factors, age, gender, level of disability, and the type of device used. The success of assistive device rehabilitation is affected by many factors such as the duration and correct use of the device by the individual, their attitude towards the assistive device, their participation in treatment, and their expectations.
In low-income countries, disabled individuals have the right to access affordable, available assistive devices such as prosthetics and orthotic services according to the Convention on the Rights of Persons with Disabilities. Prosthetic and orthotic services are limited in low-income countries. In order to improve mobility and ensure greater participation of people with physical disabilities and amputees in society, assistive devices should be increased and user satisfaction should be investigated. In todays prosthetic and orthotic field, low-cost devices need to be developed and the multi-faceted satisfaction of users needs to be evaluated in terms of improvements in rehabilitation programs. Test batteries are frequently preferred in the evaluation of user satisfaction in orthosis and prosthetic rehabilitation. Generally, surveys based on individuals; expectations, satisfaction, experiences during daily life and statements of the individual regarding their assistive device are preferred. When the literature is examined, it is seen that there are few studies evaluating the use of orthosis and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the multi-faceted satisfaction of individuals using assistive devices. Female/male individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive device will be included in the study on a voluntary basis. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) survey is planned to be used for the evaluation of assistive technology user satisfaction, Orthotics and Prosthetics User\'s Survey (OPUS) is planned to be used for the evaluation of orthosis prosthesis user satisfaction.
- Conditions
- Assistive Technology, Orthosis, Prosthesis, Device
- Being tested
- No intervention
- Keywords
- assistive device, orthosis, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| orthosis users | Not described Receives: Other: No intervention | |
| prosthesis users | Not described Receives: Other: No intervention | |
| ambulation assistive device | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) is a survey used to assess the satisfaction of individuals using technological assistive devices. The first version of the survey, developed by Demers et al. in 1996 to assess the satisfaction of using assistive technological devices, consists of 24 items.
Measured: 5 minute
Secondary outcomes (2)
Orthotics and Prosthetics Users Survey (OPUS)
It is preferred to maintain activity development awareness in prosthesis and orthosis applications, to evaluate changes in quality of life, to make quality assessments and to evaluate patients; functional status and satisfaction with prosthesis and orthosis services.
Measured: 5 minute
Semi-structured Interview Form
Qualitative interviews were conducted with participants using orthotics, prosthetics, and ambulation assistive devices until data saturation was achieved. The aim of the interviews was to comprehensively understand participants' satisfaction with assistive devices and to identify the underlying reasons. The questions asked in the interviews were developed by the researchers based on their clinical experience, expert opinions, and a comprehensive literature review. Five questions were determined for orthotics, prosthetics, and gait assistive devices (Table 1). To determine the suitability of the draft questions, the researchers consulted five experts in the field. Qualitative data were obtained through semi-structured individual interviews. The interviews were conducted face-to-face and recorded with the participants' consent. Each interview lasted approximately 20 minutes.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Jun 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assistive TechnologyStudies 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
- Other
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yılmaz, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585280
- Sponsor's protocol ID
- E-10840098-202.3.02-3739
- Status last verified
- May 2026
- First submitted
- 3 Sep 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Satisfaction Levels Among Users of Assistive Devices - a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06585280
- Acronym / sponsor ID
- E-10840098-202.3.02-3739
- Conditions
- Assistive Technology, Orthosis, Prosthesis, Device
- Keywords
- assistive device, orthosis, prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 5 Sep 2024 (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.
Assistive devices are of critical importance for the independence and participation of disabled individuals in society and there is an increasing interest in them today. When the literature is examined, it is seen that there are few studies evaluating the use of orthotic and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the satisfaction of individuals using assistive devices in a multifaceted way.
Detailed description
Assistive devices are medical devices designed to support the individuals functions and increase their activities. Assistive devices are of critical importance for the independence and participation of disabled individuals in society and are of increasing interest today. The use of assistive devices is a process consisting of different steps to increase the individuals participation in daily life activities.
Although assistive devices cannot completely eliminate disability, they can increase independence by reducing negative effects. There are many problems encountered in the selection of assistive devices. The problems encountered include the cost of the assistive device, the necessary application training, service delivery, environmental factors, age, gender, level of disability, and the type of device used. The success of assistive device rehabilitation is affected by many factors such as the duration and correct use of the device by the individual, their attitude towards the assistive device, their participation in treatment, and their expectations.
In low-income countries, disabled individuals have the right to access affordable, available assistive devices such as prosthetics and orthotic services according to the Convention on the Rights of Persons with Disabilities. Prosthetic and orthotic services are limited in low-income countries. In order to improve mobility and ensure greater participation of people with physical disabilities and amputees in society, assistive devices should be increased and user satisfaction should be investigated. In todays prosthetic and orthotic field, low-cost devices need to be developed and the multi-faceted satisfaction of users needs to be evaluated in terms of improvements in rehabilitation programs. Test batteries are frequently preferred in the evaluation of user satisfaction in orthosis and prosthetic rehabilitation. Generally, surveys based on individuals; expectations, satisfaction, experiences during daily life and statements of the individual regarding their assistive device are preferred. When the literature is examined, it is seen that there are few studies evaluating the use of orthosis and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the multi-faceted satisfaction of individuals using assistive devices. Female/male individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive device will be included in the study on a voluntary basis. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) survey is planned to be used for the evaluation of assistive technology user satisfaction, Orthotics and Prosthetics User\'s Survey (OPUS) is planned to be used for the evaluation of orthosis prosthesis user satisfaction.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| orthosis users | – | Other: No intervention |
| prosthesis users | – | Other: No intervention |
| ambulation assistive device | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive devices will be included in the study on a voluntary basis.
Key inclusion criteria (3 listed)
- Female/male individuals using upper extremity orthosis, lower extremity orthosis, trunk orthosis, lower or upper extremity prosthesis and/or assistive device
- No cognitive and/or psychological problems
- Individuals without a diagnosis of neurological disease
Key exclusion criteria (4 listed)
- Diagnosed with a vestibular system disorder
- Diagnosed with a sensorimotor system disorder
- Having an autoimmune disorder
- Individuals with a history of hospitalization for more than three days in the last six months
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 |
|---|---|---|
| No interventionNo intervention | Other | ambulation assistive device, orthosis users, prosthesis users |
Primary outcome
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: 5 minute
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) is a survey used to assess the satisfaction of individuals using technological assistive devices. The first version of the survey, developed by Demers et al. in 1996 to assess the satisfaction of using assistive technological devices, consists of 24 items.
2 secondary outcomes
Orthotics and Prosthetics Users Survey (OPUS)
Time frame: 5 minute
Semi-structured Interview Form
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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 Assistive Technology and Orthosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 11 May 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) (time frame: 5 minute). 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 11 May 2026.