Assistive Device Satisfaction

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: Completed
• Conditions: Prosthesis; Assistive Technology; Orthosis; Device
• Intervention / Treatment: Other: No intervention

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: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	5 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	20 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prosthesis; orthosis; assistive device
• Other Study ID 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