NCT06585280

Brief 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 patient satisfaction. The aim of this study is to investigate the satisfaction of individuals using assistive devices in a multifaceted way.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

September 3, 2024

Last Update Submit

April 30, 2025

Conditions

Keywords

assistive deviceorthosisprosthesis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

orthosis users

Other: No intervention

prosthesis users

Other: No intervention

Interventions

No intervention

orthosis usersprosthesis users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant (Orthotist and Prosthetist)

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 5, 2024

Study Start

June 15, 2024

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations