Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

NCT ID: NCT04775667

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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).

Conditions

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Amputation

Keywords

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kinesiophobia amputation pain fear of fall quality of life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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questionnaires for clinical assessments

questionnaires for clinical assessments

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Physical Medicine and Rehabilitation Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Orucu Atar

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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12

Identifier Type: -

Identifier Source: org_study_id