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Trial registered on ANZCTR


Registration number
ACTRN12619001390178
Ethics application status
Approved
Date submitted
27/06/2019
Date registered
10/10/2019
Date last updated
10/10/2019
Date data sharing statement initially provided
10/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does computer based cognitive retraining influence cognitive function, activities of daily living and rehabilitation outcomes of orthopaedic patients? A Comparative Study.
Scientific title
Does computer based cognitive retraining influence cognitive function, activities of daily living and rehabilitation outcomes of orthopaedic patients? A Comparative Study.
Secondary ID [1] 298616 0
Nil known
Universal Trial Number (UTN)
U1111-1234-7798
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured neck of femur 313160 0
Total hip replacement 313161 0
Total knee replacement 313162 0
Total shoulder replacement 313163 0
Fractured pelvis 313164 0
upper limb orthopaedic fracture 313171 0
lower limb orthopaedic fracture 313172 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311626 311626 0 0
Occupational therapy
Musculoskeletal 312282 312282 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapy will be completed by two occupational therapist one with 13 years experience and 11 years experience. Cognitive training will be completed on the RehaCom- a computer based cognitive retraining program. Retraining is done through graded targeted exercises, eg memory, attention, concentration, executive function. Sessions are for 30 minutes for 10 sessions. Sessions may be twice a day dependent on patients fatigue and ability to participate.
Sessions are done initially under supervision and guidance from the OT. Distant supervision may be used if appropriate. The computer program also adjusts the level of difficulty based on patient performance. If the patient is having difficulties the system identifies this and alerts the patient to seek assistance from therapist.
Intervention code [1] 314678 0
Treatment: Other
Intervention code [2] 315412 0
Rehabilitation
Comparator / control treatment
Standard occupational therapy care including assessment and retraining of daily living tasks, review of home set up and existing equipment and providing information on requirements for discharge
Control group
Active

Outcomes
Primary outcome [1] 320331 0
Total score on Montreal Cognitive Assessment
Timepoint [1] 320331 0
Baseline and after 10 sessions of offered therapy
Primary outcome [2] 320332 0
Functional Independence Measure
Timepoint [2] 320332 0
With in 48 hours of admission and 48 hours of discharge
Primary outcome [3] 320333 0
Kettle Test
Timepoint [3] 320333 0
At completion of 10 sessions of therapy as applicable or close to discharge- patient needs to be mobile enough to complete assessment
Secondary outcome [1] 371268 0
Length of stay- days in rehabilitation calculated from admission and discharge dates. This information will be obtained from hospital records.
Timepoint [1] 371268 0
Measured on discharge from rehabilitation unit
Secondary outcome [2] 371269 0
Comparison of admission and discharge location. Review of where they are admitted from eg home and where they are discharged too. This is logged through Australasian Rehabilitation Outcomes Centre and on meditech
Timepoint [2] 371269 0
On discharge from rehabilitation unit

Eligibility
Key inclusion criteria
Score on the Montreal Cognitive Assessment between 19-25, admitted and discharge from the rehabilitation unit after an orthopaedic injury or surgery,
Minimum age
65 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pre-existing cognitive impairment, younger than 65 or older than 85 years, unable to provide consent

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)
Allocation concealed and is was completed by contacting Allied Health Manager not involved in the study who was the holder of the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A retrospective review of patients previously admitted to the rehabilitation unit was undertaken. A review of patients meeting the study inclusion and exclusion criteria was complete and then determined the mean number of patients in a 6 and 12 month period who will be suitable for the study, was used to determine the sample size.

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)
QLD
Recruitment hospital [1] 13961 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 26731 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 302976 0
Charities/Societies/Foundations
Name [1] 302976 0
Gallipoli Medical Research Foundation
Address [1] 302976 0
Greenslopes Private Hospital
Newdegate Street, Greenslopes, QLD, 4120
Country [1] 302976 0
Australia
Primary sponsor type
Individual
Name
Carissa Bernal Carrillo
Address
Greenslopes Private Hospital
Newdegate Street, Greenslopes, QLD, 4120
Country
Australia
Secondary sponsor category [1] 302932 0
None
Name [1] 302932 0
Address [1] 302932 0
Country [1] 302932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303528 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 303528 0
Greenslopes Private Hosptial
Newdegate Street, Greenslopes, QLD, 4120
Ethics committee country [1] 303528 0
Australia
Date submitted for ethics approval [1] 303528 0
27/02/2019
Approval date [1] 303528 0
13/03/2019
Ethics approval number [1] 303528 0

Summary
Brief summary
Purpose of the study is to compare if orthopaedic patients with mild cognitive impairment who recieve computer based cognitive therapy have better changes in cognitive function, activities of daily living and overall rehabilitation outcomes when compared to patients receiving standard care. The secondary aim is evaluate the usability of computer based cognitive therapy for orthopedic patients in rehabilitation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93974 0
Mrs Carissa Bernal Carrillo
Address 93974 0
Greenslopes Private Hospital
Newdegate Street, Greenslopes, QLD, 4120
Country 93974 0
Australia
Phone 93974 0
+61 733947378
Fax 93974 0
+61 733947135
Email 93974 0
bernalcarrilloc@ramsayhealth.com.au
Contact person for public queries
Name 93975 0
Mrs Carissa Bernal Carrillo
Address 93975 0
Greenslopes Private Hospital
Newdegate Street, Greenslopes, QLD, 4120
Country 93975 0
Australia
Phone 93975 0
+61 733947378
Fax 93975 0
+61 733947135
Email 93975 0
bernalcarrilloc@ramsayhealth.com.au
Contact person for scientific queries
Name 93976 0
Mrs Carissa Bernal Carrillo
Address 93976 0
Greenslopes Private Hospital
Newdegate Street, Greenslopes, QLD, 4120
Country 93976 0
Australia
Phone 93976 0
+61 733947378
Fax 93976 0
+61 733947135
Email 93976 0
bernalcarrilloc@ramsayhealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results