Comparison of Classical Prosthesis and Silicone Prosthesis

NCT ID: NCT05850104

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-24

Study Completion Date

2023-11-24

Brief Summary

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The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Detailed Description

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The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

This study will be useful for prescribing the appropriate prosthesis in patients with Chopart amputation.

Conditions

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Traumatic Amputation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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classical prosthesis group

the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation

the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Intervention Type OTHER

the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

silicone prosthesis group

the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation

the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Intervention Type OTHER

the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Interventions

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the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Intervention Type OTHER

the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged between 18-65
* Having a unilateral traumatic Chopart amputation
* To have completed prosthesis training
* Using prosthesis for at least 6 hours a day
* Being at K3-K4 activity level

Exclusion Criteria

* Bilateral lower extremity amputation
* Presence of wound on stump
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Örücü Atar, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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38

Identifier Type: -

Identifier Source: org_study_id

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