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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

Protocol summary

Study aim
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
Design
Two arm parallel group randomised trial with blinded outcome assessor, on 30 patients. For randomization, blocks of 4 will be used on "randomization.com "website.
Settings and conduct
The samples will be selected from Shahid Motahari and Shohadaye Yaft Abad Hospital in Tehran, who will randomly receive the interventions after completing the informed consent form. The outcome assessor is blinded. The evaluation will be done in 3 time points: the beginning, after 8 weeks and follow-up 4 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2nd and 3rd degree burns with at least 0.5% TBSA and involve the palmar/dorsal of the hand, in the age range of 18 to 60 years, 1 week after skin graft surgery, cognitive level above 21 based on MMSE. Exclusion criteria: face and respiratory tracts burns, tendon injuries, fractures, infection in the surgery area
Intervention groups
The intervention group will receive occupational therapy interventions based on the ICF model and ICF coreset for people with burn injuries, which includes interventions in the most important areas of body structure and functions, participation in activities and changes in environmental factors, and interactive goal setting with clients. The control group will receive conventional occupational therapy interventions based on Dang Tang et al., including stretching, ROM exercises, improving sensation, increasing muscle strength and endurance, scar and edema management, and splinting. The treatment duration will be 8 weeks, 2 sessions per week and each session will be 45 minutes.
Main outcome variables
Occupational Performance; Satisfaction with occupational performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231212060341N1
Registration date: 2023-12-30, 1402/10/09
Registration timing: prospective

Last update: 2023-12-30, 1402/10/09
Update count: 0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Dorsa Hamedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
hamedi.d@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Occupational Therapy Interventions in Patients with Hand Burns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
missing more than two therapy sessions lake of willingness or cooperation for continuing the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 5, Rehabilitation Sciences School, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.IUMS.REC.1402.644

Health conditions studied

1

Description of health condition studied
Burns of upper extremity
ICD-10 code
T23.0
ICD-10 code description
Burn of unspecified degree of wrist and hand

Primary outcomes

1

Description
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)

2

Description
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)

Secondary outcomes

1

Description
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)

2

Description
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)

3

Description
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)

4

Description
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)

5

Description
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

6

Description
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

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Laleh Lajevardi
Street address
Shahid Rashid Yasemi Ave., Valiasr St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8877 0031
Email
laleh23275@yahoo.com

2

Recruitment center
Name of recruitment center
Shohadaye Yaft Abad Hospital
Full name of responsible person
Laleh lajevardi
Street address
Southern Alghadir Blv., Alghadid Sq., Moalem Aq., Yaft Abad
City
Tehran
Province
Tehran
Postal code
1377714775
Phone
+98 21 6680 7851
Email
laleh23275@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Deputy of research and Technology, Iran University of Medical Sciences, Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
laleh23275@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dorsa Hamedi
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
d.hamedi.ot@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laleh Lajevardi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
laleh23275@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dorsa Hamedi
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Sciences School, No. 5, Madadkaran Ave., Shahnazari Ave., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
d.hamedi.ot@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
At least 6 months after the publication of the articles resulting from the clinical trial.
To whom data/document is available
Researchers working in research centers and universities.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.
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