Comparison of Different Types of Prosthetic Foott | NCT05691998

Studies
Comparison of Different Types of Prosthetic Foott

NCT05691998

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status

Unknown status

Last Update Posted

Jan 20, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

the Previous Prosthetic Foot Experience of Patients With Amputation

Interventions

Prosthetic foot questionnaire

Countries

Not provided

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2023Estimated

Primary Completion Date

Mar 1, 2023Estimated

Completion Date

Apr 1, 2023Estimated

First Submitted Date

Jan 11, 2023

First Submission Date that Met QC Criteria

Jan 11, 2023

First Posted Date

Jan 20, 2023Actual

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

Jan 11, 2023

Last Update Posted Date

Jan 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasin Demir, Associated Professor, 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

The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

Detailed Description

One of the main goals in the rehabilitation of amputees is to provide optimal and natural ambulation. For this purpose, suitable socket-suspension type, appropriate knee joint and foot should be prescribed. In the selection of feet, the age, occupation, characteristics of the geographical region, mental status and activity level should be considered. In addition, the previous prosthesis experience of the people should definitely be taken into account during prosthesis prescribing.The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		the previous prosthesis experience	Other: Prosthetic foot questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prosthetic foot questionnaire	Other	Prosthetic foot related questions will be asked to the patients	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qestion 1	Walking on the straight road	through study completion, an average of one and a half months
Qestion 2	Walking on uneven terrain	through study completion, an average of one and a half months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 18-65 years
Lower limb amputation
Having used at least 2 different foot types (carbon, hydrolic, microprocessor-controlled)

Exclusion Criteria:

Having used the single type of foot until now
Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

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

A total of 20 patients with lower limb amputation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yasin Demir, Associated Professor	Contact	+903122911806		dr_yasindemir@yahoo.com

Overall Officials

Name	Affiliation	Role
Yasin Demir, Associated Professor	dr_yasindemir@yahoo.com	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40813189	Derived	Kilinc Kamaci G, Artuc SE, Ceylan H, Tekin E, Kanlioglu O, Orucu Atar M, Demir Y, Aydemir K. Comparison of different types of prosthetic feet in patients with unilateral transtibial amputation; patient perspective. J Orthop Sci. 2026 Mar;31(2):358-363. doi: 10.1016/j.jos.2025.07.007. Epub 2025 Aug 14.