Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

November 21, 2021 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with traumatic lower extremity amputation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of one and a half months
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)).
through study completion, an average of one and a half months
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.
through study completion, an average of one and a half months
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.
through study completion, an average of one and a half months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Merve Orucu Atar, Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 21, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12 (Israel lung Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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