The Effect of Proprioceptive Neuromuscular Facilitation and Mirror Therapy on Range of Motion, Pain, Functionality, Kinesophobia and Quality of Life in Patients With Upper Extremity Burns

June 24, 2019 updated by: Mine Seyyah, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Purpose of the study; The aim of this study was to investigate the effect of two different exercise programs on joint patency, pain, functionality, kinesophobia and quality of life in upper extremity burn patients. Lütfi Kırdar Training and Research Hospital Burn and Wound Center and unilateral upper extremity burns will consist of individuals aged 18-65 years. 48 burn patients who volunteered to participate in the study will be included in the study. Demographic information of the cases will be recorded. Joint range of motion and pain will be evaluated with the Visual Analogue Scale (VAS) before and after the treatment program. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to evaluate upper extremity functions. TAMPA Kinezophobia questionnaire will also be used for kinesiophobia. To evaluate the quality of life, Burn-Specific Health Scale developed for burn patients will be used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Joint range of motion of the subjects will be measured with a goniometer. Pain will be evaluated with the Visual Analogue Scale (VAS). In order to evaluate the upper extremity functions, the validity and reliability of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, conducted by Tülin Düger et al. The TAMPA Kinezophobia questionnaire, which has been validated and validated in 2011, will be used for kinesiophobia. The Burn-Specific Health Scale developed for burn patients will be used to evaluate the quality of life. The validity and reliability study of the questionnaire was conducted by Mehmet Adam et al.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34865
        • Recruiting
        • Wound and Burn Center
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute Burn Patients

Description

Inclusion Criteria: -18-65 years of age, -the unilateral upper extremity burn, -the understanding of the given information, the application of mirror therapy and the ability to accurately express the level of pain that prevents cognitive, affective and verbal communication There is no problem and no visual impairment, - Turkish reading and writing, - Paralysis, plaster, etc. that will prevent movement in the extremity opposite the burned extremity. to be cognitive enough to understand the surveys,

- Agreeing to participate voluntarily in the study -

Exclusion Criteria:

  • T.C. Ministry of Health Kartal Lütfi Kırdar Training and Research Hospital Burn and Wound Center treated patients between the ages of 0-18,
  • Burn patients who refused to participate in the study, - Patients with bilateral upper extremity burns

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
proprioceptive neuromuscular facilitation
PNF will be applied to randomly selected patients.
Other: Effect of exercise
Once the data are available, we hope to have information about which of the exercise practices included in the rehabilitation program of acute upper extremity burn patients is more effective.
Mirror therapy
Mirror therapy will be applied to randomly selected patients.
Other: Effect of exercise
Once the data are available, we hope to have information about which of the exercise practices included in the rehabilitation program of acute upper extremity burn patients is more effective.
Standart therapy
Standard treatment will be applied to randomly selected patients.
Other: Effect of exercise
Once the data are available, we hope to have information about which of the exercise practices included in the rehabilitation program of acute upper extremity burn patients is more effective.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic information
Time Frame: 10 minutes
Demographic information of the cases will be recorded.Age, cause of burn, burn zone, burn percentage will be recorded.
10 minutes
Joint range of motion
Time Frame: 15 minutes
The goniometer will measure the range of motion.
15 minutes
Pain assesment
Time Frame: 5 minutes
Pain will be assessed by visual pain scale.
5 minutes
Functional assesment
Time Frame: 15 minutes
Shoulder-Arm Function Questionnaire will be used to evaluate upper extremity functions.
15 minutes
Fear of Motion
Time Frame: 10 minutes
The Tampa Kinesophobia Questionnaire will be used to assess fear of movement.
10 minutes
Quality of Life Assesment
Time Frame: 15 minutes
A scale specific to burn patients will be used to evaluate the quality of life.(Burn Specific Health Scale)
15 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mine Seyyah, DrLutfiKirdar

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kartal Wound and Burn Center

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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