Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

NCT04775667 | Completed

• 1 other identifier: 12
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Amputation

Keywords

kinesiophobia; amputation; pain; fear of fall; quality of life

Outcome Measures

Primary Outcomes (4)

• Tampa Scale for Kinesiophobia (TSK)

  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)

  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)

  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)

  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

Interventions

questionnaires for clinical assessments OTHER

questionnaires for clinical assessments

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with traumatic lower extremity amputation

You may qualify if:

• aged 18-65 years
• time after amputation ≥ 6 months
• unilateral or bilateral amputation above the ankle level
• using a prosthesis

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Merve Orucu Atar

  Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)