Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 12:34 AM
NCT ID: NCT04775667
Brief Summary: There are limited studies examining kinesiophobia and factors associated with kinesophobia in patients with lower limb amputation. The aim of this study is to illustrate the level of kinesiophobia in patients with traumatic lower extremity amputation and to analyze the correlation between kinesiophobia and associated factors (pain, prosthesis satisfaction, fear of fall, quality of life). This cross-sectional study will involve 52 patients with traumatic lower extremity amputation. Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). All patients will point the severity of sound limb pain, residual limb pain, low back pain and the overall prosthesis, socket system and prosthetic foot satisfaction on a Visual Analogue Scale (VAS). Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP).
Detailed Description: Kinesiophobia is defined as an unreasonable, excessive, and debilitating fear of physical activity and movement resulting from a feeling of susceptibility to painful injury or re-injury. Kinesiophobia was demonstrated to be related to lower levels of physical activity in people with chronic pain. As a result, there is an increased risk of sedentary lifestyle. Inactivity increases the risk of chronic pain as well as other health problems such as cardiovascular diseases. Kinesiophobia also is related to poor treatment outcomes. The negative effects of kinesiophobia on rehabilitation processes including exercise programs and thus its importance in the clinical course were illustrated in studies on various diseases. There are limited studies examining kinesiophobia and factors associated with kinesophobia in patients with lower limb amputation. The aim of this study is to illustrate the level of kinesiophobia in patients with traumatic lower extremity amputation and to analyze the correlation between kinesiophobia and associated factors (pain, prosthesis satisfaction, fear of fall, quality of life). his cross-sectional study will involve 52 patients with traumatic lower extremity amputation. Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). All patients will point the severity of sound limb pain, residual limb pain, low back pain and the overall prosthesis, socket system and prosthetic foot satisfaction on a Visual Analogue Scale (VAS). Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP).
Study: NCT04775667
Study Brief:
Protocol Section: NCT04775667