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IRCT20231212060341N1 IRCT 2023-12-30 Iran University of Medical Sciences Effect of Occupational Therapy Interventions in Patients with Hand Burns The Comparison between Occupational Therapy Interventions based on ICF Model vs Conventional Interventions on Participation and Satisfaction of Patients with Hand Burns in Occupational Areas 2024-04-03 anticipated 30 Complete https://irct.ir/trial/74431 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: block balance randomization method with block size of 4 and allocation ratio of 1:1 will be used in this study. The "Randomization.com" website will be used for generation of random sequence. The Sequentially Numbered Selected Opaque Envelopes(SNSOE) will be used in order to allocation concealment, Blinding description: In this study, the outcome assessor will be blinded. Due to nature of the interventions, the blinding of participants and therapist is not possible. N/A Burns of upper extremity. Intervention 1: Intervention group: Occupational therapy interventions based on the ICF Model: Participants with hand burn injuries, who are included in the study according to the inclusion criteria, will receive occupational therapy interventions based on the ICF model and the comprehensive ICF-coreset for the rehabilitation of patients with burn injuries. In this type of interventions, the entire treatment process is applied interactively with clients according to the "rehabilitation cycle" described by the ICF. In the beginning of intervention process, ICF-based documentation forms and ICF-Categorical Profile are completed. Then, in the step of evaluating and setting treatment goals, ICF-Assessment Sheet and ICF-Intervention Table will be used and completed in the implementation of interventions and ICF-Evaluation Display in the evaluation step. By using the ICF-based documentation forms, through participation with clients and the therapist's clinical reasoning, it is determined which body structures and functions are impaired, what are the restrictions and limitations in the client's participation and activities, and finally, which environmental factors are seen as facilitating or restricting in the treatment of clients. Then, according to the clients' prioritization, occupational therapy interventions will be provided for 8 weeks and 2 sessions per week and each session will last 45 minutes. Intervention 2: Control group: Conventional Occupational Therapy Interventions : The control group received conventional interventions based on the protocol of Dang Tang et al. These interventions include stretching, active and passive range of motion exercises, sensory improvement exercises, muscle strength and endurance exercises, scar and edema management, and splints. Conventional occupational therapy interventions will be provided for 8 weeks and 2 sessions per week and each session will last 45 minutes. Yes - There is a plan to make this available What will be shared: The data related to the primary and secondary outcome of the individuals participating in the research after anonymization, and the publication of the articles from the clinical trial, will be made available to the academic researchers upon their request. When: At least 6 months after the publication of the articles resulting from the clinical trial. To whom: Researchers working in research centers and universities. Conditions: In order to carry out systematic review and meta-analysis studies, by maintaining the intellectual property right of the data and referring to the study of the data, it is made available to people from scientific and academic institutions. Where to obtain: To receive data, researchers should contact the authors by e-mail or refer to the following address: Mrs. Dorsa Hamedi, email: d.hamedi.ot@gmail.com Dr. Laleh Lajevardi, email: laleh23275@yahoo.com address: Occupational Therapy Dep., Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd., Tehran. How to obtain: The researcher must send his request to the authors in an official form on behalf of the organization working in it. The request should include the purpose of accessing the data, and the resulting consequences. Comments:
public Dorsa Hamedi
Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 d.hamedi.ot@gmail.com Iran University of Medical Sciences scientific Laleh Lajevardi
Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 laleh23275@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) depth of burn: 2 and 3 degree Estimated burn size based on TBSA: 0.5% which including anterior or posterior of hand Thermal burn injuries semi thickness skin graft surgery at least on week after skin graft surgery no comorbidities such as fractures, tendon injuries, amputations and etc. the burn site should not include the face and respiratory tracts score of 21 and above in Mini Mental Status Examination 18 years 65 years Both missing more than two therapy sessions lake of willingness or cooperation for continuing the study T23.0 Burn of unspecified degree of wrist and hand Rehabilitation Rehabilitation Intervention group: Occupational therapy interventions based on the ICF Model: Participants with hand burn injuries, who are included in the study according to the inclusion criteria, will receive occupational therapy interventions based on the ICF model and the comprehensive ICF-coreset for the rehabilitation of patients with burn injuries. In this type of interventions, the entire treatment process is applied interactively with clients according to the "rehabilitation cycle" described by the ICF. In the beginning of intervention process, ICF-based documentation forms and ICF-Categorical Profile are completed. Then, in the step of evaluating and setting treatment goals, ICF-Assessment Sheet and ICF-Intervention Table will be used and completed in the implementation of interventions and ICF-Evaluation Display in the evaluation step. By using the ICF-based documentation forms, through participation with clients and the therapist's clinical reasoning, it is determined which body structures and functions are impaired, what are the restrictions and limitations in the client's participation and activities, and finally, which environmental factors are seen as facilitating or restricting in the treatment of clients. Then, according to the clients' prioritization, occupational therapy interventions will be provided for 8 weeks and 2 sessions per week and each session will last 45 minutes. Control group: Conventional Occupational Therapy Interventions : The control group received conventional interventions based on the protocol of Dang Tang et al. These interventions include stretching, active and passive range of motion exercises, sensory improvement exercises, muscle strength and endurance exercises, scar and edema management, and splints. Conventional occupational therapy interventions will be provided for 8 weeks and 2 sessions per week and each session will last 45 minutes. Occupational Performance (participation): Performing (achieving) the occupations chosen by the individual, which is the result of the dynamic interaction of the individual, the contexts , and the occupation. Timepoint: The measurement of occupational performance would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Canadian Occupational Performance Measure (COPM). Satisfaction with Occupational Performance: The level of satisfaction with performance in the most important occupations from the individual's own perspective. Timepoint: The measurement of occupational performance would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Canadian Occupational Performance Measure (COPM). Quality of Life (QoL). Timepoint: The measurement of quality of life would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Burn Specific Health Scale-Brief (BSHS-B). Social Participation. Timepoint: The measurement of social participation would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Participation Scale (P-scale). Hand Function. Timepoint: The measurement of hand function would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Disabilities of Hand, Arm and Shoulder (DASH). Pain. Timepoint: The measurement of pain would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Visual Analogue Scale (VAS). Range of Motion in Upper extremity's joints. Timepoint: The measurement of range of motion in upper extremity's joints would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Goniometry. Edema. Timepoint: The measurement of edema would be at the beginning of the study, 8 weeks (after interventions), and 12 weeks (follow up). Method of measurement: Tape Measure. Iran University of Medical Sciences Approved 2023-10-23 Ethics committee of Iran University of Medical Sciences No. 5, Rehabilitation Sciences School, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd Tehran Tehran Iran (Islamic Republic of)