Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000972820
Ethics application status
Approved
Date submitted
6/09/2012
Date registered
10/09/2012
Date last updated
10/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapist-devised physical rehabilitation programs conducted by the family member(s) of inpatients following an acquired brain injury: a pilot randomised control trial.
Scientific title
A comparison of therapist-devised physical rehabilitation programs conducted by the family member(s) and usual care to improve physical function with inpatients following an acquired brain injury: a pilot randomised control trial.
Secondary ID [1] 281180 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury 287346 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287684 287684 0 0
Physiotherapy
Neurological 287698 287698 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapist devised physical rehabilitation programs conducted by the family member(s), 3 x 30 minute sessions per week for 4 weeks. Family members will undertake two training sessions with the Physiotherapist initially and then the Physiotherapists will review weekly (ie 5 times in total).
Intervention code [1] 285631 0
Rehabilitation
Comparator / control treatment
standard care. Usual rehabilitation programs will take place; this includes individual physiotherapy sessions with the frequency ranging between 1 - 5 times per week according to individual needs. Normally, clients may also undertake extra exercise sessions with rehabilitation assistants or independently if able and if suitable they can attend fitness and sports groups up to twice a week. The rehabilitation unit’s goal is that every client attends at least one physical activity session each weekday. Individuals will continue to receive speech therapy, occupational therapy and psychotherapy as required.
Control group
Active

Outcomes
Primary outcome [1] 287927 0
Clinical Outcomes Variables Scale
Timepoint [1] 287927 0
Baseline and 5 weeks after intervention commences
Secondary outcome [1] 299065 0
Mood of family member's measured by the CESD-R Scale
Timepoint [1] 299065 0
baseline and 5 weeks after intervention commences
Secondary outcome [2] 299066 0
Satisfaction with healthcare. The Critical Care Family Satisfaction Survey constructs of Information, Proximity and Support will be used with five items from these domains chosen. Family members will rate the following items on a five point scale:
*Sharing in decisions regarding my family member's care on a regular basis.
*Ability to share in the care of my family member.
*Support and encouragement given during my family member's stay in the rehabilitation unit.
* Physiotherapists availability to speak with me.
* Preparation for my family member's discharge from the rehabilitation unit.
Timepoint [2] 299066 0
baseline and 5 weeks after intervention commences

Eligibility
Key inclusion criteria
Inpatients admitted for rehabilitation following an Acquired Brain Injury and undertaking physiotherapy as part of their rehabilitation. They must have at least one family member prepared to participate in the study and a cognitive and physical ability to participate in a physical rehabilitation program devised by the treating physiotherapist and conducted by family members.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients with Acquired Brain Injury anticipated to be in the inpatient rehabilitation setting for less than five weeks

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)
Participants will be randomly allocated to groups by an individual off-site to the trial and blind to baseline measures. Opaque, sealed envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation from computer generated tables.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285951 0
Self funded/Unfunded
Name [1] 285951 0
Country [1] 285951 0
Primary sponsor type
University
Name
University of South Australia
Address
North Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 284775 0
Hospital
Name [1] 284775 0
Hampstead Rehabilitation Centre (Brain Injury Rehabilitation Unit)
Address [1] 284775 0
Hampstead Road, Northfield, SA, 5085
Country [1] 284775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287986 0
Royal Adelaide Hopsital
Ethics committee address [1] 287986 0
Ethics committee country [1] 287986 0
Australia
Date submitted for ethics approval [1] 287986 0
Approval date [1] 287986 0
06/08/2012
Ethics approval number [1] 287986 0
120711

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

Contacts
Principal investigator
Name 34677 0
Address 34677 0
Country 34677 0
Phone 34677 0
Fax 34677 0
Email 34677 0
Contact person for public queries
Name 17924 0
Shylie Mackintosh
Address 17924 0
University of South Australia
North Terrace
Adelaide
SA 5000
Country 17924 0
Australia
Phone 17924 0
+61 8 8302 2075
Fax 17924 0
+61 8 8302 2853
Email 17924 0
[email protected]
Contact person for scientific queries
Name 8852 0
Shylie Mackintosh
Address 8852 0
University of South Australia
North Terrace
Adelaide
SA 5000
Country 8852 0
Australia
Phone 8852 0
+61 8 8302 2075
Fax 8852 0
+61 8 8302 2853
Email 8852 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.