Assistive Device Satisfaction

May 6, 2026 updated by: merve yılmaz, Istanbul Medipol University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Beykoz
      • Istanbul, Beykoz, Turkey (Türkiye), 34810
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
orthosis users
Other: No intervention
No intervention
prosthesis users
Other: No intervention
No intervention
ambulation assistive device
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Orthotics and Prosthetics Users Survey (OPUS)
Time Frame: 5 minute
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.
5 minute
Semi-structured Interview Form
Time Frame: 20 minutes
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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-202.3.02-3739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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