Clinical trial NCT04775667: Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation
Official title: Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Keywords: kinesiophobia
amputation
pain
fear of fall
quality of life
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic lower extremity amputation

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).

Eligibility criteria: Inclusion Criteria:

1. aged 18-65 years
2. time after amputation ≥ 6 months
3. unilateral or bilateral amputation above the ankle level
4. using a prosthesis

Exclusion Criteria:

1. upper extremity amputation
2. the presence of musculoskeletal or neurological disease that could cause functional impairment other than amputation
3. the presence of neurological deficit.

Primary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: through study completion, an average of one and a half months
measure: Visual Analogue Scale (VAS)
timeFrame: through study completion, an average of one and a half months
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: through study completion, an average of one and a half months
measure: Nottingham Health Profile (NHP)
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
name: Merve Orucu Atar
role: PRINCIPAL_INVESTIGATOR
References: