Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, Turkey (Türkiye)
NCT Number: NCT05850104
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.
Looking for future studies?
Notify Me18 year–65 year
Male
Observational
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)).
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.
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).
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).
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Other
Comparison of Classical Prosthesis and Silicone Prosthesis in Patients With Chopart Amputation
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.
Published trials that share one or more normalized conditions with this study.
NCT06284005
Amputation, Amputation, Traumatic
Florence, FI, Italy
View Trial DetailsNCT05059886
Amputation, Traumatic, Leg Lower Amputation
Nîmes, France
View Trial DetailsNCT00985842
Amputation, Amputation, Traumatic
Seattle, Washington, United States
View Trial DetailsNCT00942890
Amputation, Traumatic, Nervous System Diseases
San Diego, California, United States
View Trial Details