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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]

Nil

Universal Trial Number (UTN)

U1111-1125-6774

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Trauma patients

Condition category

Condition code

Injuries and Accidents

Fractures

Injuries and Accidents

Other injuries and accidents

Physical Medicine / Rehabilitation

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]

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]

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]

Day 3 and day 5 of mobilisation by the physiotherapist

Secondary outcome [1]

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]

From date/ time first mobilised by the physiotherapist to date/ time deemed physically ready for discharge home

Secondary outcome [2]

Acute hospital length of stay via the hospital database

Timepoint [2]

Acute hospital discharge

Secondary outcome [3]

Discharge from acute hospital destination via the hospital database

Timepoint [3]

Acute hospital discharge

Secondary outcome [4]

Patient confidence with mobility level, readiness for discharge and satisfaction with physiotherapy service questionnaire

Timepoint [4]

Day of acute hospital discharge

Secondary outcome [5]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Automobile Club of Victoria

Address [1]

438 Lt Collins Street, Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Self funded/Unfunded

Name [2]

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

The Alfred

Address

Commercial Road, Prahran VIC 3181

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Research and Ethics Unit

Ethics committee address [1]

Commercial Road, Ground floor, Linay Pavillion, Prahran VIC 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/09/2011

Ethics approval number [1]

1/11/0341

Summary

Brief summary

The Alfred Hospital Trauma Service admits over 5000 patients per year with 1 in 5 deemed to have suffered major trauma (Trauma Registry, The Alfred, Trauma Audit 2010). Acute hospital care must be as efficient and effective as possible, given the high demand and the current pressure on inpatient beds.  The doctors stabilise the patient medically and surgically as soon as possible, while the allied health team prepares the patient physically, psychologically and socially for timely discharge. For the trauma physiotherapists this involves treating patients in the emergency department, the intensive care unit and the ward.  Despite dedicated clinical resources, trauma patient care may be impacted on by other acute care priorities and this can result in sub-optimal patient recovery and delayed discharge. A recent audit (2010) undertaken in the trauma service at The Alfred revealed only 33% of patients who could sit out of bed for meals, actually did so.  We hypothesize that inadequate resources and low patient self confidence results in an unacceptable achievement of simple daily tasks after trauma.

The optimal intensity / frequency of physiotherapy intervention for trauma patients in the acute care is unclear. Studies have shown early and intensive physiotherapy to be safe following stroke (Bernhardt et al 2008) and within the intensive care context (Schweickert et al 2008, Hopkins et al 2009).  It also assists with functional independence and discharge destination gains following acquired brain injury (Turner-Stokes et al 2005), femoral fracture (Oldmeadow et al 2006, Pendleton et al 2007) and ankle fracture (Kimmel et al 2010). 

The goal of the physiotherapy intervention in the acute hospital is to prepare the patient physically for discharge to the community, commonly detailed as independence in transfers and ambulation (with or without a gait aid) and the ability to safely negotiate steps. These criteria are achieved through a regime of strengthening exercises and gait retraining. It seems reasonable to hypothesise that success may be enhanced by increasing the patients opportunity to practice these skills and may result in improved functional ability, a shorter hospital length of stay and more discharges directly home. Information regarding the optimal intensity / frequency of physiotherapy input will inform appropriate resource allocation to ensure maximum benefit for the patient, their families and the health care system.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Sara Calthorpe

Address

The Alfred Physiotherapy Department
4th floor Phillip Block
The Alfred
Commercial Road
Prahran VIC 3181

Country

Australia

Phone

+61390763452

Fax

s.calthorpe@alfred.org.au

Contact person for public queries

Name

Sara Calthorpe

Address

The Alfred
Physiotherapy Department
4th Philip Block
Commercial Road
Prahran
VIC 3181

Country

Australia

Phone

+61390763452

Fax

s.calthorpe@alfred.org.au

Contact person for scientific queries

Name

Sara Calthorpe

Address

The Alfred
Physiotherapy Department
4th Philip Block
Commercial Road
Prahran
VIC 3181

Country

Australia

Phone

+61390763452

Fax

s.calthorpe@alfred.org.au

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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No additional documents have been identified.

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