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Trial registered on ANZCTR


Registration number
ACTRN12611000412932
Ethics application status
Approved
Date submitted
15/04/2011
Date registered
20/04/2011
Date last updated
27/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the addition of a standing balance class to usual therapy improve balance, mobility and physical functioning
among rehabilitation inpatients?
Scientific title
Does the addition of a standing balance class to usual therapy improve balance, mobility and physical functioning
among rehabilitation inpatients?
Secondary ID [1] 253403 0
Nil
Universal Trial Number (UTN)
U1111-1119-0349
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance 260955 0
Mobility 260956 0
Function 260957 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259092 259092 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive usual care as well as participate in a 1 hour standing balance circuit
class, involving exercises aimed at improving balance, three times a week for two weeks. These classes will be
held in the rehabilitation gym and run by experienced physiotherapy staff.

The standing balance circuit class consists of 7 stations; each station consists of a different exercise with 3 levels of difficulty. The class is supervised by two therapists with a maximum of 8 patients participating in the group. Each station lasts for 6 minutes. Patients will perform 6 of the 7 stations during the session. Patients are to perform the level of exercise the therapist deems appropriate without using their hands for assistance.
Intervention code [1] 257855 0
Rehabilitation
Comparator / control treatment
Standard care. Usual therapy in the Rehabilitation unit at Bankstown-Lidcombe Hospital consists of daily (Monday to Friday) assessment and treatment by the multidisciplinary team (including medical, physiotherapy, and occupational therapy, and consults with other health disciplines as indicated). Therapy is provided in individual and/or group sessions. The usual care group will not be offered the standing balance circuit class.
Control group
Active

Outcomes
Primary outcome [1] 261946 0
The primary outcome is balance. Balance will be assessed by 5 balance tests; feet apart, feet side-by-side, semi-tandem (heel of one foot beside the big toe of the other foot), tandem (heel of one foot in front and touching the other foot), and single leg stance. Each test will be performed without aid or upper limb support and timed up to a maximum of 10 seconds. The total time summed from the 5 balance tests will form the primary measure.
Timepoint [1] 261946 0
Baseline, and at 2 weeks and 3 months after randomisation.
Secondary outcome [1] 268855 0
Physical Functioning.

This will be assessed using the Basic Mobility and Daily Activity domains of the Computer Adaptive Testing version of the Boston University Activity Measure for Post Acute Care (AM-PAC) (Haley et al 2004). The AM-PAC measures functional outcome by using Item Response Theory. The AM-PAC Basic Mobility domain includes 101 items that address basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. The AM-PAC Daily Activity domain includes 70 items that address basic self care and instrumental activities of daily life.
Timepoint [1] 268855 0
2 weeks and 3 months after randomisation.
Secondary outcome [2] 268856 0
Mobility.

This will be assessed by the Short Physical Performance Battery (Guralnik et al 1994). This includes a chair stand test (5 repetitions) and a 4 metre walking test, as well as 3 of the 5 standing balance tests (tandem stance, semi-tandem stance, and side-by-side stance) performed as part of the primary outcome measure.
Timepoint [2] 268856 0
Baseline, and at 2 weeks and 3 months after randomisation.
Secondary outcome [3] 268857 0
Fall incidence.

This will be measured by participant and/or 'person responsible' self-report. In-patient fall data will also be collected via the hospital Incident Information Managment System (incident reporting system).
Timepoint [3] 268857 0
Baseline, and at 2 weeks and 3 months after randomisation via interview.
Secondary outcome [4] 268858 0
Hospital readmissions.

The number of readmissions will be collected by participant and/or 'person responsible' self-report. Data will also be collected via electronic hospital medical records.
Timepoint [4] 268858 0
3 months after randomisation.

Eligibility
Key inclusion criteria
1. Able to stand unaided independently for at least 30 seconds(supervision or standby assist is allowed but no ‘hands on’ assistance).
2. Able to participate in group therapy sessions with minimal supervision.
3. Admitted to the ward for physical rehabilitation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to fully weight bear as ordered by a medical officer (i.e. non, partial or touch weight bearing status through one or both legs).
2. Have a medical condition precluding exercise, e.g. unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm.
3. Have an identified multi-resistant organism infection or other infection that would pose a significant risk to others in a group setting (e.g. MRSA, VRE, TB).

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)
Sealed opaque envelopes will be kept on site that detail participant numbers on the front and a piece of paper inside that says "Participant number X is in the X group". The envelopes will be prepared by someone not involved in recruitment processes or decisions about eligibility i.e. a concealed allocation system will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will be determined via computer generated random numbers within random blocks.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
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] 258324 0
Hospital
Name [1] 258324 0
Bankstown Lidcombe Hospital
Address [1] 258324 0
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country [1] 258324 0
Australia
Funding source category [2] 264893 0
Government body
Name [2] 264893 0
Ingham Health Research Institute
Address [2] 264893 0
Locked Mailbag 7017
LIVERPOOL BC
NSW 1871
Country [2] 264893 0
Australia
Funding source category [3] 284793 0
Charities/Societies/Foundations
Name [3] 284793 0
Physiotherapy Research Foundation
Address [3] 284793 0
PO Box 437, Hawthorn BC, VIC 3122
Country [3] 284793 0
Australia
Primary sponsor type
Individual
Name
Mr Daniel Treacy
Address
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country
Australia
Secondary sponsor category [1] 257482 0
Individual
Name [1] 257482 0
Mr Karl Schurr
Address [1] 257482 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country [1] 257482 0
Australia
Secondary sponsor category [2] 257483 0
Individual
Name [2] 257483 0
A/Prof Cathie Sherrington
Address [2] 257483 0
The George Institute for Global Health
PO Box M201
Missenden Road
Sydney
NSW 2050
Country [2] 257483 0
Australia
Other collaborator category [1] 251771 0
Individual
Name [1] 251771 0
Mr Bradley Lloyd
Address [1] 251771 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country [1] 251771 0
Australia
Other collaborator category [2] 251772 0
Individual
Name [2] 251772 0
Ms Angela Vratsistas
Address [2] 251772 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country [2] 251772 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260302 0
Sydney South West Area Health Service HREC - Western Zone
Ethics committee address [1] 260302 0
SSWAHS HREC - Western Zone
Locked Bag 7017
Liverpool BC
NSW 1871
Ethics committee country [1] 260302 0
Australia
Date submitted for ethics approval [1] 260302 0
02/11/2010
Approval date [1] 260302 0
Ethics approval number [1] 260302 0
HREC/10/LPOOL/187

Summary
Brief summary
The purpose of the study is to investigate whether the addition of six standing balance circuit classes to usual therapy over a 2 week period improves balance, mobility and physical functioning among rehabilitation inpatients. Participants will be allocated at random into one of two groups (Usual Care and Additional Training). People in the Usual Care group will receive standard care as offered by the Bankstown Lidcombe Hospital Physiotherapy service. People in the Additional Training group will receive usual care as well as participate in a 1 hour standing balance circuit class, involving exercises aimed at improving balance, three times a week for two weeks. All participants will be assessed at enrollment into the study, 2 weeks later, and again at 3 months. Assessments will include a questionnaire about mobility and activities of daily living, as well as physical tests including a 4 metre walking test, chair stand test, and balance tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32091 0
Address 32091 0
Country 32091 0
Phone 32091 0
Fax 32091 0
Email 32091 0
Contact person for public queries
Name 15338 0
Mr Daniel Treacy
Address 15338 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country 15338 0
Australia
Phone 15338 0
+61 2 9722 7256
Fax 15338 0
+61 2 9722 7125
Email 15338 0
daniel.treacy@sswahs.nsw.gov.au
Contact person for scientific queries
Name 6266 0
Mr Daniel Treacy
Address 6266 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country 6266 0
Australia
Phone 6266 0
+61 2 9722 7256
Fax 6266 0
+61 2 9722 7125
Email 6266 0
daniel.treacy@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results