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Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

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ClinicalTrials.gov Identifier: NCT04775667
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Description
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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).

Condition or disease Intervention/treatment
Amputation Other: questionnaires for clinical assessments

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 Design
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

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MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Intervention Details:
  • Other: questionnaires for clinical assessments
    questionnaires for clinical assessments

Outcome Measures
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Primary Outcome Measures :
  1. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: through study completion, an average of one and a half months ]
    Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). The questionnaire contains 17 items that uses a 4-point Likert-type scale (from 1 (strongly disagree) to 4 (strongly agree)). A score of 39 or above will be used in order to distinguish those with a high level of kinesophobia. The validity and reliability of the Turkish version of TKS has been demonstrated.

  2. Visual Analogue Scale (VAS) [ Time Frame: through study completion, an average of one and a half months ]
    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 Visua Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)).

  3. Falls Efficacy Scale-International (FES-I) [ Time Frame: through study completion, an average of one and a half months ]
    Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The FES-I is a self-report questionnaire, containing 16 items scored on a four-point scale (from 1 (no fear whatsoever) to 4 (very fearful)). The questionnaire provides information about the level of concern associated with falls during 16 various activities of daily living.

  4. Nottingham Health Profile (NHP) [ Time Frame: through study completion, an average of one and a half months ]
    The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP). NHP consists of 38 questions on six different subscales that include physical activity, pain, sleep, fatigue, social isolation and emotional reactions. Each subscale of NHP is scored between 0 and 100, and higher scores illustrate a decrease in QoL. It has been shown that NHP is a reliable scale for measuring health-related quality of life in patients with amputation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with traumatic lower extremity amputation
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775667


Locations
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Turkey
Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Investigators
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Principal Investigator: Merve Orucu Atar Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
More Information
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Responsible Party: Yasin Demir, Physical Medicine and Rehabilitation Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04775667    
Other Study ID Numbers: 12
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital:
kinesiophobia
amputation
pain
fear of fall
quality of life
Additional relevant MeSH terms:
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Kinesiophobia
Phobic Disorders
Anxiety Disorders
Mental Disorders