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IRCT20170709034968N1 IRCT 2018-01-22 Ahvaz University of Medical Sciences The effect of range of motion exercises on activities of daily living and quality of life Effect of range of motion exercises on burnt patients' daily activities and quality of life 2017-07-23 anticipated 60 Complete https://irct.ir/trial/26573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are divided randomly bloked (6 Bloks) into 2 control and intervention groups. N/A Burn. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Participants information must remain confidential.
public Safa Najafi
Student Researches Committee, Faculty of Nursing and Midwifery Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8070 najafi_s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Simin Jahani
Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8070 jahanisimin50@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 60 years Both Patients who need graft surgery during the study. Patients who have unstable vital signs. T20، T21 Burns and corrosions of external body surface, specified by site Rehabilitation Rehabilitation 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. 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. 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. 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. -. Timepoint: -. Method of measurement: -. Ahvaz University of Medical Sciences Approved 2017-06-17 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Deputy of Development and Research, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)