Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000152921
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
9/02/2011
Date last updated
10/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A combined one-on-one/group-circuit physiotherapy
format affords cost-benefits over one-on-one
physiotherapy without compromising clinical outcomes
during post-acute lower-limb orthopaedic in-patient
rehabilitation: a prospective randomised controlled trial
Scientific title
Do patients aged 50 years or over who have post-acute phase lower limb orthopaedic surgery who are in-patient in rehabilitation; that have a combined one-on-one/group-circuit physiotherapy format, compared with traditional one-on-one physiotherapy format show "cost-saving" as measured by length-of-stay and required physiotherapist contact hours?
Secondary ID [1] 253547 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post acute lower limb orthopaedic inpatient in rehabiliation 261105 0
Condition category
Condition code
Musculoskeletal 259245 259245 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 259246 259246 0 0
Physiotherapy
Physical Medicine / Rehabilitation 259247 259247 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants received physiotherapy twice daily as per the standard treatment regime in the Rehabilitation Ward. Group B participants (experimental group) received a one-on-one physiotherapy session in the morning and a group-circuit session in the afternoon (both 30 minutes duration, 5 days a week, for the length of the particpants admission). The non-physiotherapy components of multidisciplinary care, including occupational therapy, dietetics and pain management, were provided as required to both groups as part of standard practice within the Rehabilitation Ward.
The Group B participants' morning session, that is one-on-one physiotherapy sessions. Were conducted under the direct and constant supervision of a physiotherapist from the Rehabilitation Ward, with a 1:1 therapist-to-patient ratio maintained at all times.These sessions were conducted as per usual care and were not based on any particular treatment protocol; rather, they were tailored to the individual patient based on the clinical decisions of the treating physiotherapist.
In the afternoon Group B participants' group-circuit physiotherapy sessions included a maximum of six participants at any one time, with each class supervised by one physiotherapist and one physiotherapist-assistant working on the Rehabilitation Ward. These sessions included a set of core exercises that targeted flexibility/range of motion, functional strength, balance, mobility and endurance. Each participant worked at each station for 2 minutes before rotation to the next station.
Intervention code [1] 257975 0
Rehabilitation
Comparator / control treatment
Group A (control group) received a one-on-one physiotherapy session in the morning and afternoon. Both 30 minutes in duration, 5 days a week and for the length of the participants admission.
The one-on-one physiotherapy sessions were conducted under the direct and constant supervision of a physiotherapist from the Rehabilitation Ward, with a 1:1 therapist-to-patient ratio maintained at all times.These sessions were conducted as per usual care and were not based on any particular treatment protocol; rather, they were tailored to the individual patient based on the clinical
decisions of the treating physiotherapist. The non-physiotherapy components of multidisciplinary care, including occupational therapy, dietetics and pain management, were provided as required to both groups as part of standard practice within the Rehabilitation Ward.
Control group
Active

Outcomes
Primary outcome [1] 262069 0
"Cost-saving" as measured by length-of-stay and required physiotherapist contact hours. This is in the point of view of the investigators.
Timepoint [1] 262069 0
Across the trial period January 2009 to December 2009
Secondary outcome [1] 273088 0
Level of perceived pain at rest using a Visual Analog Scale (VAS)
Timepoint [1] 273088 0
Within 24 hours of admission and on the day prior to the patient's planned discharged from the rehabiliation ward.
Secondary outcome [2] 273089 0
Functional mobility as measured by the Berg Balance scale.
Timepoint [2] 273089 0
Within 24 hours of admission and on the day prior to the patient's planned discharged from the rehabiliation ward.
Secondary outcome [3] 273090 0
Physical mobility as measured by the Timed-Up-and-Go (TUG)
Timepoint [3] 273090 0
Within 24 hours of admission and on the day prior to the patient's planned discharged from the rehabiliation ward.
Secondary outcome [4] 273091 0
Physical mobility as measured by the timed 10m walk-test (10mWT)
Timepoint [4] 273091 0
Within 24 hours of admission and on the day prior to the patient's planned discharged from the rehabiliation ward.
Secondary outcome [5] 273092 0
Mobility aid use during the TUG and 10mWT was scored according to a 5-point scale where: 1 = no aid; 2 = Single Point Stick (SPS)/crutches; 3 = Four-Wheel-Walker (4WW); 4 = Hopper; and, 5 = Forearm Support
Frame (FASF).
Timepoint [5] 273092 0
Within 24 hours of admission and on the day prior to the patient's planned discharged from the rehabiliation ward

Eligibility
Key inclusion criteria
(i) age of 50 years or over; and, (ii) admission for post-acute phase lower-limb orthopaedic in-patient rehabilitation, specifically following knee or hip arthroplasty, pelvic fracture and/or lower-limb open-reduction-internal-fixation (ORIF) surgery. In cases involving athroplasty, patients were included whether the surgical prothesis was a total- or hemi-arthroplasty and, whether the surgery was a primary or revision procedure.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i)under postoperative non-weight-bearing orders and/or if they had received surgery to both lower-limbs (ii) age of less than 50 years; (iii) non-orthopaedic reason for admission; (iv) orthopaedic day patients; (v) concomitant neurological, autoimmune or unstable cardiovascular condition; and, (vi) those with cognitive impairment as
specified by a MMSE score of less than 24/30.

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)
All subjects that met the inclusion criteria that was admitted to the rehab ward. All beds in the ward were sequentially designated as “A” or “B”, with the treatment allocation code (control group “A” or experimental roup “B”). The nurse administrator responsible for bed allocation was not involved in the study and was unaware of the meaning attached to the bed allocation code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were randomly assigned into either the control group “A” or the experimental group “B”. Randomisation was generated from a simple random admission bed allocation system, whereby all beds in the ward were sequentially designated as “A” or “B”, with the treatment allocation code (control group “A” or experimental roup “B”) corresponding to the code attached to the bed that was allocated to each patient on the basis of ‘the next available’
at the time of admission to the Rehabilitation Ward.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
89
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258430 0
Hospital
Name [1] 258430 0
John Flynn Private Hosptial
Country [1] 258430 0
Australia
Primary sponsor type
Hospital
Name
John Flynn Private Hosptial
Address
42 Inland Drive
Tugun
QLD 4224
Country
Australia
Secondary sponsor category [1] 257578 0
University
Name [1] 257578 0
Bond University
Address [1] 257578 0
Faculty of Helathscience and Medicine
Bond Univerisity
QLD 4229
Country [1] 257578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260414 0
John Flynn Hospital Human Research Ethics Committee
Ethics committee address [1] 260414 0
Ethics committee country [1] 260414 0
Australia
Date submitted for ethics approval [1] 260414 0
Approval date [1] 260414 0
21/10/2008
Ethics approval number [1] 260414 0
8/09/2011

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

Contacts
Principal investigator
Name 32172 0
Address 32172 0
Country 32172 0
Phone 32172 0
Fax 32172 0
Email 32172 0
Contact person for public queries
Name 15419 0
Philip Abery
Address 15419 0
42 Inland Drive
Tugun
QLD 4224
Country 15419 0
Australia
Phone 15419 0
+617 55989718
Fax 15419 0
Email 15419 0
[email protected]
Contact person for scientific queries
Name 6347 0
Philip Abery
Address 6347 0
42 Inland Drive
Tugun
QLD 4224
Country 6347 0
Australia
Phone 6347 0
+617 55989718
Fax 6347 0
Email 6347 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.