Comparison of Classical Prosthesis and Silicone Prosthesis

Completed

• Conditions: Traumatic Amputation
• Interventions: 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.

• Registration Number: NCT05850104
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Study Start: 2023-05-24
• Primary Completion: 2023-11-24
• Study Completion: 2023-11-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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
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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	through study completion, an average of one and a half months	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)).
Locomotor capacity index	through study completion, an average of one month	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).
Likert scale	through study completion, an average of one month	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).
Short Form 36 (SF-36)	through study completion, an average of one and a half months	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.

Trial Locations

Locations (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey