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Trial registered on ANZCTR


Registration number
ACTRN12615001172594p
Ethics application status
Submitted, not yet approved
Date submitted
5/10/2015
Date registered
2/11/2015
Date last updated
16/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does increased intensity of occupational therapy improve occupational performance and hand function in people hospitalized with acute upper limb burns?
Scientific title
Does one extra 30 minute session per day of occupational therapy improve occupational performance and hand function in people hospitalized with acute upper limb burns?
Secondary ID [1] 287604 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burn to upper limb
 296409 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296676 296676 0 0
Occupational therapy
Injuries and Accidents 296720 296720 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two 30 minute sessions of occupational therapy per day during acute inpatient admission comprising:
- passive and/or active hand or arm exercises; and/or
- encouragement of performance of daily living activities involving hand motion (such as feeding, grooming, personal care, playing games) using adapted equipment where required; and/or
- fabrication or modification of custom made upper limb orthoses

Both sessions will be carried out with a Grade 2 occupational therapist during the acute inpatient admission when the patient is moved from intensive care unit to the burns ward.

Number/duration of occupational therapy sessions per day will be recorded via inpatient treatment statistics (occasions of service and time per session)
Intervention code [1] 293000 0
Rehabilitation
Comparator / control treatment
one 30 minute session of occupational therapy per day during acute inpatient admission. This is standard care administered between 01/09/15 – 31/12/15.
Control group
Historical

Outcomes
Primary outcome [1] 296281 0
hand function (as measured by QuickDASH)
Timepoint [1] 296281 0
at discharge from hospital
Primary outcome [2] 296282 0
Independence in self care and mobility (as measured by the Functional Assessment for Burns)
Timepoint [2] 296282 0
on discharge from hospital
Secondary outcome [1] 318051 0
length of stay according to electronic hospital records
Timepoint [1] 318051 0
on discharge from hospital

Eligibility
Key inclusion criteria
Admission to the Victorian Adult Burns Service:
- historical controls: admission between 01/09/15 – 31/12/15
- Intervention: admission between 01/02/16 – 31/05/16

Burns to one or both upper limbs (any thickness)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comprehend written or spoken versions of patient-rated outcome measure (quickDASH) – NB we will use an interpreter or provide this in the patient’s preferred language where possible

Any known impairment in hand or arm function prior to burn (e.g. stroke, amputation, hemiplegia, spasticity, Rheumatoid arthritis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cohort study:
- historical control group admitted between 01/9/15 - 31/12/15
- intervention group admitted between 1/2/16 - 31/5/16
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study is influenced by the number of admissions to the VABS during September 2015 and May 2016. There were 88 patients admitted to VABS between January and June of 2015 with upper limb burns. Thus, it is estimated that once inclusion and exclusion criteria has been applied for each sixteen week period, we may expect approximately 50 participants in each cohort.

A total of 44 patients (22 per group) is required to have a 90% chance of detecting, as significant at the 5% level, the minimum clinically important difference (15 points) in the quickDASH between groups.

All outcome data will be tested for normality of distribution. If normally distributed, t-tests will be used to compare group outcomes; if not, data will be log-transformed where possible or non-parametric tests will be used.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
31/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4430 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10635 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292168 0
Self funded/Unfunded
Name [1] 292168 0
Country [1] 292168 0
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd
Prahran 3004
Victoria
Country
Australia
Secondary sponsor category [1] 290841 0
None
Name [1] 290841 0
Address [1] 290841 0
Country [1] 290841 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293640 0
Alfred HREC
Ethics committee address [1] 293640 0
55 Commercial Rd
Prahran 3004
Victoria
Ethics committee country [1] 293640 0
Australia
Date submitted for ethics approval [1] 293640 0
08/10/2015
Approval date [1] 293640 0
Ethics approval number [1] 293640 0

Summary
Brief summary
It is estimated that approximately 80% of major burns involve one or both hands. Occupational therapists have a major role in providing hand and upper limb orthoses and instigating exercise and functional activities when structures are adequately healed. Although there are agreed occupational therapy treatment approaches for patients with upper limb burns, there has been no research into the optimal dose of therapy.
This project aims to compare two different doses of inpatient occupational therapy for inpatients with upper limb/hand burns in terms of the impact on hand function, self care and length of stay.
We will do this by creating two separate groups of participants (group allocation is based on admission dates);
1 control group (admitted between 1/9/15 and 31/12/15) who have received usual occupational therapy care, which is approximately one x 30 minute session daily.
2 Intervention group (admitted between 1/2/16 and 31/5/16) will receive usual occupational therapy care, plus an additional 30 minutes of daily therapy.
Outcomes achieved will then be compared between groups.
Trial website
Trial related presentations / publications
Public notes
As we are only collecting routine hospital data, and controls are exposed to "usual occupational therapy care", ethics approval to use data from controls was not gained prior to recruitment.

Contacts
Principal investigator
Name 60810 0
Dr Lisa O'Brien
Address 60810 0
Occupational Therapy
The Alfred
55 Commercial Rd
Prahran 3004
Victoria
Country 60810 0
Australia
Phone 60810 0
+61390763526
Fax 60810 0
Email 60810 0
[email protected]
Contact person for public queries
Name 60811 0
Lisa O'Brien
Address 60811 0
Occupational Therapy
The Alfred
55 Commercial Rd
Prahran 3004
Victoria
Country 60811 0
Australia
Phone 60811 0
+61390763526
Fax 60811 0
Email 60811 0
[email protected]
Contact person for scientific queries
Name 60812 0
Lisa O'Brien
Address 60812 0
Occupational Therapy
The Alfred
55 Commercial Rd
Prahran 3004
Victoria
Country 60812 0
Australia
Phone 60812 0
+61390763526
Fax 60812 0
Email 60812 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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