Burn; ArmNCT03997942
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
An observational study of Burn; Arm, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn; Arm
- What is being tested?
- Effect of exercise
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 15 Dec 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Burn Patients
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Wound and Burn Center
Istanbul, 34865
Mine Seyyah, Msc, 0905333566908, mine-fzt@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Burn; Arm
- Being tested
- Effect of exercise
- Keywords
- burn, physiotherapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive neuromuscular facilitation | PNF will be applied to randomly selected patients. Receives: Other: Effect of exercise | |
| Mirror therapy | Mirror therapy will be applied to randomly selected patients. Receives: Other: Effect of exercise | |
| Standart therapy | Standard treatment will be applied to randomly selected patients. Receives: Other: Effect of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information
Demographic information of the cases will be recorded.Age, cause of burn, burn zone, burn percentage will be recorded.
Measured: 10 minutes
Joint range of motion
The goniometer will measure the range of motion.
Measured: 15 minutes
Pain assesment
Pain will be assessed by visual pain scale.
Measured: 5 minutes
Functional assesment
Shoulder-Arm Function Questionnaire will be used to evaluate upper extremity functions.
Measured: 15 minutes
Fear of Motion
The Tampa Kinesophobia Questionnaire will be used to assess fear of movement.
Measured: 10 minutes
Quality of Life Assesment
A scale specific to burn patients will be used to evaluate the quality of life.(Burn Specific Health Scale)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 May 2019
- Primary completion20 Sep 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn; ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mine Seyyah, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Mine Seyyah, Study chair, DrLutfiKirdar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997942
- Sponsor's protocol ID
- Kartal Wound and Burn Center
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03997942
- Acronym / sponsor ID
- Kartal Wound and Burn Center
- Conditions
- Burn; Arm
- Keywords
- burn, physiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 May 2019 (actual)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| proprioceptive neuromuscular facilitation | – | Other: Effect of exercisePNF will be applied to randomly selected patients. |
| Mirror therapy | – | Other: Effect of exerciseMirror therapy will be applied to randomly selected patients. |
| Standart therapy | – | Other: Effect of exerciseStandard treatment will be applied to randomly selected patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Burn Patients
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of exerciseOnce 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. | Other | Mirror therapy, Standart therapy, proprioceptive neuromuscular facilitation |
Primary outcome
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.
Joint range of motion
Time frame: 15 minutes
The goniometer will measure the range of motion.
Pain assesment
Time frame: 5 minutes
Pain will be assessed by visual pain scale.
Functional assesment
Time frame: 15 minutes
Shoulder-Arm Function Questionnaire will be used to evaluate upper extremity functions.
Fear of Motion
Time frame: 10 minutes
The Tampa Kinesophobia Questionnaire will be used to assess fear of movement.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Seyyah study chair
DrLutfiKirdar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn; Arm, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mine Seyyah, Msc (0905333566908, mine-fzt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic information (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.