Wheelchair Use in Patients With Amputation | NCT05648331

Studies
Wheelchair Use in Patients With Amputation

NCT05648331

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status

Unknown status

Last Update Posted

Jan 3, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Amputation, Wheelchair

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Estimated

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Dec 5, 2022

First Submission Date that Met QC Criteria

Dec 5, 2022

First Posted Date

Dec 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2022

Last Update Posted Date

Jan 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasin Demir, Associated Proffessor, Gaziler Physical Medicine and Rehabilitation Education and Research HospitalPrincipal Investigator

Lead Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There are no specific criteria for wheelchair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed.

Detailed Description

There are no specific criteria for chair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed. Thus, it is thought that the main points to be considered while prescribing a wheelchair in patients with amputation can be determined.

Patients with traumatic unilateral or bilateral lower extremity amputation who are hospitalized or applied to outpatient clinics will be included in the study. Demographic and clinical characteristics of the patients will be recorded. Current age, time since the injury (in months), occupation, etiology (mine,rocket launcher, rifle, shrapnel, etc.), amputation level, amputation side, accompanying upper extremity problem, last operation reason, and activity level, knee joint type (hydraulic, simple microprocessor, other microprocessor), foot type (carbon, hydraulic, microprocessor controlled), socket-suspension type, daily use of prosthesis (hour/day), use of assistive device or AFO, how long he/she has been using a wheelchair, the type of wheelchair (light manual, active, battery powered), the reason for using a wheelchair, the reason for not using, the frequency of using a wheelchair, the upper extremity problem/pain while using the chair will be recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wheelchair type	Active, light, powered	through study completion, an average of one and a half months

Secondary Outcomes

Measure	Description	Time Frame
Reason for wheelchair use	Mobility, upper extremity pain, transfer	through study completion, an average of one and a half months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18 and 65 years, time since amputation ≥ 6 months, unilateral or bilateral LLA above the ankle level

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

The age limit of 18-65 years was determined because age may affect the age-related activity level and isokinetic measurements of the patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yasin Demir	Contact	+905303244119		dr_yasindemir@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziler Physical and Rehabilitation Medicine Training and Research Hospital, University of Health Sciences	Recruiting	Ankara			Turkey (Türkiye)