Comparison of Classical Prosthesis and Silicone Prosthesis

Traumatic Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850104
• Other study ID #: 38
• Status: Completed
• Start date: May 24, 2023
• Est. completion date: November 24, 2023

Study information

• Verified date: March 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Traumatic Amputation

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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