Comparison of Classical Prosthesis and Silicone Prosthesis

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital24 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Amputation

Interventions

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 and 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.OTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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)).

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: through study completion, an average of one month

Data from ClinicalTrials.gov

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