Comparison of Classical Prosthesis and Silicone Prosthesis

Study Overview
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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.

Official Title
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Comparison of Classical Prosthesis and Silicone Prosthesis in Patients With Chopart Amputation

Conditions
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Traumatic Amputation

Intervention / Treatment
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* Other: the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.
* Other: the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| classical prosthesis group<br>the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation | Other: the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.<br>* the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.<br>|
| silicone prosthesis group<br>the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation | Other: the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.<br>* the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)). | through study completion, an average of one and a half months | 
| Short Form 36 (SF-36) | The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL. | through study completion, an average of one and a half months | 
| Locomotor capacity index | The Locomotor Capabilities Index (LCI) is a validated measure of lower-limb amputees' ability to perform activities with prosthesis. The total LCI score is the sum of the item scores and can range from 0 (worst) to 30 (best). | through study completion, an average of one month | 
| Likert scale | Level of difficulty experienced during walking on straight road, walking uneven road, ascending stairs, descending stairs, ascending ramps and descending ramps will be recorded on a 5-point Likert scale ((1) very easy, (2) easy , (3) neutral, (4) difficult, (5) very difficult). | through study completion, an average of one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satisfaction, amputation, chopart