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CompletedNCT05850104Updated Mar 19, 2024

Comparison of Classical Prosthesis and Silicone Prosthesis

An observational study in Traumatic Amputation, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
24
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Amputation

Keywords

  • amputation
  • chopart
  • satisfaction
03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's enrollment of 24 is below the median of 37 across 34 observational studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 24 patients with unilateral Chopart amputation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Bilateral lower extremity amputation
  • Presence of wound on stump
  • Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • classical prosthesis group

    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.

  • silicone prosthesis group

    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.

Interventions

  • Otherthe 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.

  • Otherthe 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05850104
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Yasin Demir (Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
May 9, 2023
Start date
May 24, 2023
Primary completion
Nov 24, 2023
Completion
Nov 24, 2023
Last update
Mar 19, 2024

Study contacts

Merve Örücü Atar, MD
principal investigator · associate professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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