|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
SLCTR |
|
Last refreshed on:
|
27 April 2013 |
|
Main ID: |
SLCTR/2012/001 |
|
Date of registration:
|
27/01/2012 |
|
Primary sponsor: |
|
|
Public title:
|
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
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
1/2/2012 |
|
Target sample size:
|
110 |
|
Recruitment status: |
Pending |
|
URL:
|
http://www.slctr.lk/trial_details.asp?reg_id={6935CA49-8426-4D01-818C-2848BEC79631} |
|
Study type:
|
Interventional |
|
Study design:
|
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.
|
|
|
Countries of recruitment
|
|
Sri Lanka
| | | | | | | |
|
Contacts
|
|
Name:
|
Mrs G.A.D. Perera
|
|
Address:
|
82/2, Ganegoda, Dompe
|
|
Telephone:
|
0714444010 |
|
Email:
|
amaradamayanthi@yahoo.com |
|
Affiliation:
|
Physiotherapist |
|
|
Name:
|
Dr. Aranjan L. Karunanyake
|
|
Address:
|
Department of Anatomy, Faculty of Medicine, University of Kelaniya
|
|
Telephone:
|
0773062184 |
|
Email:
|
aranjan13@yahoo.co.uk |
|
Affiliation:
|
Senior Lecturer |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Burn injury
Consent to participate in the study
Exclusion criteria: Shoulder involvement from previous/prior injury or neurological conditions
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Burns
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
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.
|
|
Secondary Outcome(s)
|
Functional recovery and state of the axillary scar will be evaluated. Quick
DASH questionnaire, Vancouver scar scale will be used.
|
|
Secondary ID(s)
|
|
Nil known
|
|
Source(s) of Monetary Support
|
|
Self funded
|
|