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NCT Number: NCT05850104

Comparison of Classical Prosthesis and Silicone Prosthesis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 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)).

  2. Short Form 36 (SF-36)

    Time frame: 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.

  3. Locomotor capacity index

    Time frame: 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).

  4. Likert scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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