Home » Trials » SLCTR/2012/001
Effectiveness of early stretching exercises for range of motion of the shoulder joint, state of axillary scar and quality of recovery in burnt patients admitted to Burns Unit of the National Hospital of Sri Lanka
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SLCTR Registration Number
SLCTR/2012/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of early stretching exercises for range of motion of the shoulder joint, state of axillary scar and quality of recovery in burnt patients admitted to Burns Unit of the National Hospital of Sri Lanka
Public Title of Trial
Effectiveness of early stretching exercises for the function of the shoulder joint in burnt patients admitted to Burns Unit of the National Hospital of Sri Lanka
Disease or Health Condition(s) Studied
Burns
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P047/06/2010 (Ethical Review Committee, faculty of Medicine university of Kelaniya)
What is the research question being addressed?
To evaluate the range of motion (ROM) of shoulder joint, state of the axillary scar and quality of recovery in burnt patients undergoing a rehabilitation programme in comparison to a control group. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
A randomized controlled study will be conducted at Burns and Reconstructive Surgical Unit, National Hospital of Sri Lanka. Patients over 13 years of age admitted to the unit with a burn injury involving the shoulder joint will be eligible to participate in the study. The subjects will be randomized into two groups: intervention group and control group using a randomization software. Informed written consent will be obtained from all participants and treatment will be offered as to the study protocol. The control group will undergo treatment as to the usual protocol adopted in the unit for treatment of burn injury patients with shoulder involvement. The stretching exercises will be started within 48 hours of post burn injury in superficial (only the epidermis is affected due to the burn) and partial thickness (epidermis and upper part of the dermis is affected) burns. In full thickness burns (epidermis, dermis and underline tissues are affected) it will be started on 5th day after the skin graft. These stretching exercises are done within the pain tolerable limits. The number of repetitions will be increased gradually.
Inclusion criteria
Burn injury Consent to participate in the study
Exclusion criteria
Shoulder involvement from previous/prior injury or neurological conditions
Primary outcome(s)
|
1.
The range of motion of the shoulder joint, will be evaluated during and after the intervention phase of the rehabilitation programme by an independent person. Goniometer will be used. |
[ Measurements will be taken weekly for two weeks and thereafter the measurements will be done at the day of discharge and then one month, three months, six months and twelve months after the Burn injury ] |
Secondary outcome(s)
|
1.
Functional recovery and state of the axillary scar will be evaluated. Quick DASH questionnaire, Vancouver scar scale will be used. |
[ Measurements will be done at the day of discharge and then one month, three months, six months and twelve months after the Burn injury. ] |
Target number/sample size
110
Countries of recruitment
Sri Lanka
Anticipated start date
2012-02-01
Anticipated end date
2013-01-31
Date of first enrollment
2012-02-01
Date of study completion
Recruitment status
Recruiting
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2011-07-13
Approval number
P047/06/2010
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Mrs G.A.D. Perera
Physiotherapist
82/2, Ganegoda, Dompe.
Senior investigator / Dr C Perera
Consultant Plastic Surgeon
Burns and Reconstrutive Surgical Unit, National Hospital of Sri Lanka
0714444010
amaradamayanthi@yahoo.com
Contact Person for Public Queries
Dr. Aranjan L. Karunanyake
Senior Lecturer
Department of Anatomy, Faculty of Medicine, University of Kelaniya
0773062184
aranjan13@yahoo.co.uk
Primary study sponsor/organization
Dr. C. Perera -
Consultant Plastic Surgeon
Burns and Reconstrutive Surgical Unit, National Hospital of Sri Lanka
0112691111 Ext. 2839, 2455
dinira@slt.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
