Determine the effect of range of motion exercises on activity of daily living and quality of life patient with burn
Design
In this research, 60 burn patients referring to Taleghani hospital are selected according to inclusion criteria. participants will be randomly divided into two control and intervention groups.
Settings and conduct
This study is a clinical trial in the field of rehabilitation and done for burn patients in Taleghani hospital of Ahvaz. The study population includes patients with confirmed diagnosis of grade II burns. The sample are randomly assigned to two groups Intervention and control (30 persons).
Participants/Inclusion and exclusion criteria
Inclusion criteria is, second degree burns less than 40%, age between 18 to 60 years, and stable vital signs. patients who needed graft surgery are excluded of study.
Intervention groups
The Barthel's questionnaire and quality of life questionnaire were completed by two group one day prior to the intervention.The control group receives the routine care program at the hospital. Patients in the intervention group, in addition to the routine care program, performed range of motion exercises for 4 weeks, 3 times a day, each movement ten times, each time for 30 second in upper and lower extremities of burnt areas. Barthel's questionnaire will be completed after 4 weeks, and quality of life questionnaire will be completed after three months by patients in both groups.
Main outcome variables
Activities of daily living; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170709034968N1
Registration date:2018-01-22, 1396/11/02
Registration timing:retrospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Safa Najafi
Name of organization / entity
Jundishapur University of Medical Sciences Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 4326 9560
Email address
najafi_s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of JundiShapour Ahvaz University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of range of motion exercises on burnt patients' daily activities and quality of life
Public title
The effect of range of motion exercises on activities of daily living and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Second degree burn less than 40%
age range 18 to 60 years
48 hours have passed since burn injury.
No history of neurological and articular problems
having no contracture and deformity in joints.
having no mental disease or mental retardation.
having stable vital signs.
Exclusion criteria:
Patients who need graft surgery during the study.
Patients who have unstable vital signs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided randomly bloked (6 Bloks) into 2 control and intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of Development and Research, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC. 1396. 319
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20، T21
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
The Score of Activities of daily living in Bartlett's Questionnaire
Timepoint
Before intervention, one month after the intervention
Method of measurement
Bartel questionnaire: Bartel index includes 10 questions with likert scale (0-15) so the scores range is (0-100), questions related to (0-10) scores for eating, (0-5) scores for bathing, (0-5) scores for personal hygiene, (0-10) scores for getting dressed, (0-10) scores for urine control, (0-10) scores for stool control, (0-10) scores for using the toilet, (0-15) scores for transferring from bed to chair and vice versa, (0-15) scores for mobility on flat surfaces and (0-10) scores for using the stairs. The score of 100 shows total independency and the score of 0 shows absolute dependence of the individual for his/her daily activities.
2
Description
The Score of Quality of Life Questionnaire
Timepoint
Before the intervention, Three months after the intervention
Method of measurement
Burn Specific Health Scale questionnaire: This questionnaire consists of 40 questions with 5 choices of severe, many, average, few and never which are ranked from 1 to 5 respectively. So each question has the minimum score of 1 and the maximum of 5. 18 questions of this questionnaire is for physical dimension of quality of life (minimum 18 scores and maximum 200) , 11 questions for Psychological dimension and 11 questions for Social dimension (minimum 11 scores and maximum 55). With this questionnaire the quality of life is assessed for each dimension separately and also in all of the dimensions. Because the quality of life is based on the scores' average, the higher the mean, the better the quality of life and the lower mean represents lower quality of life.
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The Persian version of Burn Specific Health Scale (BSHS) and the Barthel's daily life activities questionnaire will be given to patients one day before beginning the intervention. Required explanations about how to fill in this questionnaire will also be given to all patients in the same way. In addition to care routine program، patients will go under the range of motion exercises described in this study. So all patients of intervention group will receive scheduled range of motion exercises for 4 weeks, 3 times a day, 10 sets for each movement and each set 30 seconds in each injured upper and lower limb and completely controlled (patient should perform the movements in a way which is not rapidly and uncontrollable and perform these exercises in all range of joints and slowly and be able to stop the movement in each part of range of motion if needed) depending on whether the upper limb or the lower limb is burned. These exercises will be performed on the wrists, elbows and shoulders joints in the upper limbs and the ankle and knee and thigh joints in the lower extremities. Movements will be performed in the full range of the joint, with maximum bending- straightening of joint, maximum range of abducting-adducting and maximum range of spin-to-inside and spin-to-out if possible. Exercises consist of bending and straightening in the elbow joint; bending-straightening, abducting-adducting, spinning in whole range of motion in shoulder joint; bending-straightening and rotation in all directions of joint in hand joint; bending-straightening, abducting-adducting, the inner rotation-external rotation of joint in Hip joint; bending- straightening in knee joint and bending- straightening in ankle joint. The way and how to do the exercises will be fully explained for the patient and his first-degree family in order to prevent any changes to the exercises to the extent possible. Patients are asked to carry out these exercises carefully and thoroughly until the end of the study and the investigator will directly supervise this during this study. After performing range of motion exercises for 4 weeks, the Barthel's daily activities questionnaire will be completed by the intervention group once again. Also, the quality of life questionnaire for burnt patients will be completed by patients three months after the intervention.
Category
Rehabilitation
2
Description
Control group: The Barthel's questionnaire and quality of life questionnaire were completed by patients one day prior to the intervention. Then patients in control group، went under routine hospital treatment and rehabilitation programs during 4 weeks. The questionnaire of daily life activities was completed again after one month. The quality of life questionnaire for burnt patients was completed three months after the beginning of intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Safa Najafi
Street address
Taleghani Hospital, Mostaan Ave, Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
11151 61339
Phone
+98 61 3333 1133
Email
najafis5470@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Safa Najafi
Position
Master Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Researches Committee, Faculty of Nursing and Midwifery Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8070
Fax
Email
najafi_s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8070
Fax
Email
jahanisimin50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Safa Najafi
Position
Master sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Researches Committee, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61333738331
Fax
Email
najafi_s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available