Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001231932
Ethics application status
Approved
Date submitted
16/11/2011
Date registered
1/12/2011
Date last updated
18/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is more better? Does a more intensive physiotherapy programme result in a more accelerated recovery for patients following trauma.
Scientific title
Is more better? Does a more intensive physiotherapy programme result in a more accelerated recovery for patients following trauma.
Secondary ID [1] 273315 0
Nil
Universal Trial Number (UTN)
U1111-1125-6774
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma patients 279107 0
Condition category
Condition code
Injuries and Accidents 279296 279296 0 0
Fractures
Injuries and Accidents 279297 279297 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 279419 279419 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy intervention
Usual care physiotherapy (once /day) PLUS an extra 2 physiotherapy sessions/day (two half hour sessions one on one with a physiotherapist) for every patient in the intervention group until they are discharged from the hospital or achieve physical readiness for discharge home.
The intervention group will receive daily physiotherapy as per the usual care group as well 2 additional daily treatments, 7 days per week. One treatment will involve attending a ward based gym and undertaking a supervised exercise programme tailored to the individual; standing, balance and strength exercises, stretches, walking in the rails etc as appropriate. The second treatment will be a follow up from the usual care treatment with the aim being improvement in the functional tasks achieved during the morning (usual) physiotherapy session. Improvement would be measured as an increase in independence achieved, change in gait aid used (eg progression from gutter frame to pick up frame to crutches), specific tasks achieved / attempted (eg progression from transfers to ambulation to stairs) and progression in distance walked. If the patient is located in the Intensive Care Unit (ICU), they will receive both extra sessions in ICU as the gym area is only accessible to ward patients.
Intervention code [1] 283681 0
Rehabilitation
Comparator / control treatment
Usual care physiotherapy (once/day one to one physiotherapy session) for every patient until they are discharged from the hospital or achieve physical readiness for discharge home.
This group will receive physiotherapy treatment as per usual practice in The Alfred Trauma Service, once per day, seven days a week. Treatment will be targeted to the individual patient but may involve bed based limb exercises (eg. strength exercises such as static quadriceps holds), chest physiotherapy (eg. airway clearance and lung recruitment exercises) and gait retraining (eg. weight shifting and stepping exercises). The aim is to achieve independence in transfer and ambulation tasks, or at a level of supervision if a carer is available, to allow direct discharge to home. These aims are reflected in the criteria for discharge.
Control group
Active

Outcomes
Primary outcome [1] 279910 0
The Modified Iowa Level of Assistance Scale The modified version involves assessment of the patients level of assistance required to perform four functional tasks: supine to sit, sit to stand, walk and negotiate 1 step with grading from 0 points for independence to 6 points for not tested. Walking distance is also graded from 0 points for >40 metres to 6 points for <2 metres, as is the use of any gait aid from 0 points for no gait aid to 6 points for use of a gutter frame. An overall score for the 6 components is then calculated with scores ranging from 0 to a maximum of 36.
Timepoint [1] 279910 0
Day 3 and day 5 of mobilisation by the physiotherapist
Secondary outcome [1] 294752 0
Time to physical readiness for discharge home This will be a clinical assessment defined as: independence in transfers from lying to sitting, bed mobility, transfer from bed to chair and back to bed, ambulation with or without gait aid (as required) with sufficient walking ability and negotiation of any stairs by which the patient can safely enter and exit their home.
Timepoint [1] 294752 0
From date/ time first mobilised by the physiotherapist to date/ time deemed physically ready for discharge home
Secondary outcome [2] 294869 0
Acute hospital length of stay via the hospital database
Timepoint [2] 294869 0
Acute hospital discharge
Secondary outcome [3] 294870 0
Discharge from acute hospital destination via the hospital database
Timepoint [3] 294870 0
Acute hospital discharge
Secondary outcome [4] 294871 0
Patient confidence with mobility level, readiness for discharge and satisfaction with physiotherapy service questionnaire
Timepoint [4] 294871 0
Day of acute hospital discharge
Secondary outcome [5] 294872 0
Sf12 gives a brief reliable measure of overall health status The Glasgow Outcome Score extended as measure of functional level The EQ-5D also provides a measure of health outcome
Timepoint [5] 294872 0
6 months after randomisation

Eligibility
Key inclusion criteria
Admission to The Alfred Trauma Service and deemed physically unsafe for discharge home on the day of first mobilisation by the physiotherapist
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they have no physical injuries, age < 18, unable to participate in active therapy sessions secondary to severe neurological or cognitive impairment (including pre-morbid dementia, severe head injuries), non-English speaking, an injury profile rendering the patient unable to mobilise (take steps / walk due to fracture pattern eg. bilaterally non-weight bearing secondary to pelvic fractures), patients who required assistance to mobilise prior to the accident (use of a cane or walker not an exclusion), patients admitted from a nursing home, spinal cord injuries and those with >20% burn injuries

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a computer generated program and allocation will be concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284161 0
Charities/Societies/Foundations
Name [1] 284161 0
Royal Automobile Club of Victoria
Country [1] 284161 0
Australia
Funding source category [2] 284162 0
Self funded/Unfunded
Name [2] 284162 0
Country [2] 284162 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Road, Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 269173 0
None
Name [1] 269173 0
Address [1] 269173 0
Country [1] 269173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286178 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 286178 0
Ethics committee country [1] 286178 0
Australia
Date submitted for ethics approval [1] 286178 0
Approval date [1] 286178 0
22/09/2011
Ethics approval number [1] 286178 0
1/11/0341

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33346 0
Mrs Sara Calthorpe
Address 33346 0
The Alfred Physiotherapy Department 4th floor Phillip Block The Alfred Commercial Road Prahran VIC 3181
Country 33346 0
Australia
Phone 33346 0
+61390763452
Fax 33346 0
Email 33346 0
[email protected]
Contact person for public queries
Name 16593 0
Sara Calthorpe
Address 16593 0
The Alfred Physiotherapy Department 4th Philip Block Commercial Road Prahran VIC 3181
Country 16593 0
Australia
Phone 16593 0
+61390763452
Fax 16593 0
Email 16593 0
[email protected]
Contact person for scientific queries
Name 7521 0
Sara Calthorpe
Address 7521 0
The Alfred Physiotherapy Department 4th Philip Block Commercial Road Prahran VIC 3181
Country 7521 0
Australia
Phone 7521 0
+61390763452
Fax 7521 0
Email 7521 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.