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Trial registered on ANZCTR


Registration number
ACTRN12616001468415
Ethics application status
Approved
Date submitted
13/10/2016
Date registered
21/10/2016
Date last updated
21/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early rehabilitation after traumatic brain injury (TBI)
Scientific title
The efficacy of early rehabilitation after traumatic brain injury (TBI)
Secondary ID [1] 290303 0
N-13-089
Universal Trial Number (UTN)
U1111-1188-5578
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 300548 0
Post-traumatic amnesia 300550 0
Condition category
Condition code
Neurological 300408 300408 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 300409 300409 0 0
Occupational therapy
Injuries and Accidents 300410 300410 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Condition: Activities of Daily Living (ADL) retraining

For those assigned to the treatment group, the initial functional assessment will be used to develop therapy goals and appropriate areas for skill re-training will be identified. This initial session will be approximately 30-60 minutes, one-on-one and run by an Occupational Therapist. A therapy manual, which was devised by the investigators for the purposes of this study, will then be used to guide the allocated therapy. It should be noted that the activity/ies of daily living selected to be addressed in therapy (e.g. self-feeding, bathing, light meal preparation) and the intervention provided will be catered to the individual and graded throughout treatment accordingly, whilst following an overarching structure (therapy manual). ADL retraining will involve up to one hour of one-on-one intervention each day (Mon-Fri) given by an Occupational Therapist. Intervention will occur in an inpatient hospital setting, with sessions running between 30-60 minutes in duration depending on patient tolerance. Self-care ADLs (feeding, bathing, dressing, toileting) and light domestic ADLs (light meal preparation, e.g. cup of tea and toast) and instrumental ADLs (social interaction, orientation) will be targeted in the intervention. The training will be manualised and separated into modules for each separate ADL. Given that patients will differ in terms of which ADLs require retraining, the treatment program will be flexible to allow the therapist to choose the ADLs targeted in each session. The treatment group will also receive ‘treatment as usual’ whilst in post-traumatic amnesia (PTA). The treatment will be completed by an experienced Occupational Therapist with experience in ADL retraining in TBI. The intervention period is from admission until emergence from PTA and the nature and amount of therapy delivered to each participant will be documented in detail.
Intervention code [1] 296109 0
Treatment: Other
Intervention code [2] 296161 0
Rehabilitation
Comparator / control treatment
Control Condition: Treatment as Usual.

In this condition, participants will receive no ADL retraining while in PTA. Both groups will receive the same amount of ADL retraining after the PTA phase until the time of discharge from hospital. At the Brain Injury Unit, Epworth, current input during PTA includes: daily physiotherapy, daily monitoring of PTA using the Westmead PTA scale, daily participation in a morning/orientation group and speech/dietetics regarding feeding and swallowing as required. Current occupational therapy input is limited to positioning and upper limb splinting, both as required, and does not involve daily ADL retraining therapy.
Control group
Active

Outcomes
Primary outcome [1] 299850 0
Functional Independence Measure (FIM)
Timepoint [1] 299850 0
Admission to hospital (Epworth HealthCare)
PTA emergence
Discharge from hospital
2 month follow-up
Primary outcome [2] 299852 0
Functional Assessment Measure (FAM)
Timepoint [2] 299852 0
Admission to hospital (Epworth HealthCare)
PTA emergence
Discharge from hospital
2 month follow-up
Secondary outcome [1] 328308 0
Duration of PTA measured by days from injury until a perfect score of 12 is achieved on three consecutive days on the Westmead PTA scale (WPTAS).
Timepoint [1] 328308 0
Westmead PTA scale will be administered daily from admission until emergence from PTA.
Secondary outcome [2] 328309 0
Length of inpatient stay measured measured by days form hospital admission until discharge
Timepoint [2] 328309 0
Discharge
Secondary outcome [3] 328313 0
Community Integration Questionnaire (CIQ)
Timepoint [3] 328313 0
2 month follow-up
Secondary outcome [4] 328448 0
Agitated Behaviour Scale (ABS)
Timepoint [4] 328448 0
Daily during PTA

Eligibility
Key inclusion criteria
* Participants will have a severe TBI and have been admitted to the Brain Injury Unit at Epworth Hospital in Melbourne while in the PTA phase of recovery. Participants must be in the PTA phase of recovery as the primary focus of the project is to examine the efficacy of ADL retraining during PTA.
* Participants will be able to consistently follow single stage commands in order to demonstrate the ability to engage in re-training of activities of daily living.
* Participants will be physically able to participate in (at least one of) the movement/s required for particular ADL retraining.
* For participants to remain in the study, they will need to continue to be in PTA for at least one week, following commencement of participation. Learning and functional skill development is often slowed in individuals with severe TBI and therefore this minimum time frame has been applied. If any shorter time frame were to apply it would be unrealistic to capture treatment outcomes versus standard practice. Those who emerge from PTA within one week of commencement of the training will be excluded from the study.
* Participants will be medically stable in order to participate, as reported by their treating Physician.
* Participants will be required to have been independent with personal care activities pre-morbidly.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Admitted to hospital out of PTA
* In PTA for less than one week
* Cannot follow single-stage commands
* Cannot participate in ADL retraining due to physical limitations
* Are not medically stable
* Were not independent with personal care activities pre-injury

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
* Results will be analysed using ANOVA to examine whether FIM & FAM scores for the ADL training group and the treatment as usual control groups differ at the post-PTA assessment. Should there be significant differences in baseline FIM & FAM scores these will be included as covariates.
* As secondary investigations, similar analyses will be conducted for the FIM & FAM at discharge assessment and the two month follow-up assessment, length of inpatient stay, PTA duration and Community Integration Questionnaire scores at two month follow-up.
* Using GPower we estimate that, adopting an alpha of .05, a total sample size of 108 (54 per group) would provide power of .99 to detect a moderate effect. Should we need to use ANCOVA the power would be .73.

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)
VIC
Recruitment hospital [1] 6802 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 14459 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 294683 0
Government body
Name [1] 294683 0
Institute for Safety, Compensation, and Recovery Research (ISCRR)
Address [1] 294683 0
Institute for Safety, Compensation, and Recovery Research (ISCRR)
222 Exhibition St, Melbourne VIC 3000
Country [1] 294683 0
Australia
Funding source category [2] 294684 0
Charities/Societies/Foundations
Name [2] 294684 0
William Buckland Foundation
Address [2] 294684 0
ANZ Charitable Trusts Services ANZ Executors & Tr
Level 2, 575 Bourke St
Melbourne, Vic 3000

GPO Box 2307
Melbourne, VIC 3001
Country [2] 294684 0
Australia
Funding source category [3] 294685 0
Hospital
Name [3] 294685 0
Epworth Research Institute (ERI)
Address [3] 294685 0
89 Bridge Road, Richmond VIC 3121
Country [3] 294685 0
Australia
Funding source category [4] 294686 0
University
Name [4] 294686 0
Monash Strategic Grant
Address [4] 294686 0
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country [4] 294686 0
Australia
Primary sponsor type
Individual
Name
Professor Jennie Ponsford
Address
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 293531 0
None
Name [1] 293531 0
Address [1] 293531 0
Country [1] 293531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296109 0
Epworth HealthCare Ethics Committee
Ethics committee address [1] 296109 0
Mailbox #4
89 Bridge Road Richmond, Vic 3121
Ethics committee country [1] 296109 0
Australia
Date submitted for ethics approval [1] 296109 0
Approval date [1] 296109 0
29/05/2013
Ethics approval number [1] 296109 0
581-13

Summary
Brief summary
Following emergence from coma individuals with traumatic brain injury (TBI) experience a period of confusion, amnesia, and sometimes agitation, termed post-traumatic amnesia (PTA). Guidelines for management of patients in PTA have traditionally recommended that these patients not receive active therapy during this phase. However, this management strategy has never been empirically tested and anecdotal evidence implicates potential benefits from rehabilitation during PTA. Retraining of daily living skills such as personal care activities (e.g., dressing) and domestic tasks (e.g., meal preparation), known as activities of daily living (ADLs), is a core focus of the rehabilitation program in the post-PTA phase. Efficacy of commencing ADL retraining during the PTA phase has never been systematically assessed.

The proposed randomised controlled trial is designed to evaluate the efficacy of commencing ADL retraining during the PTA phase after severe TBI (treatment group), as compared to introducing ADL retraining after emergence from PTA (treatment as usual control group).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69590 0
Prof Jennie Ponsford
Address 69590 0
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria
Country 69590 0
Australia
Phone 69590 0
+61 3 9905 1552
Fax 69590 0
Email 69590 0
jennie.ponsford@monash.edu
Contact person for public queries
Name 69591 0
Ms Jessica Trevena-Peters
Address 69591 0
Monash Epworth Rehabilitation Research Centre (MERRC)
Ground Floor, 185-187 Hoddle Street,
Richmond, Vic, 3121
Country 69591 0
Australia
Phone 69591 0
+61 3 9426 8923
Fax 69591 0
Email 69591 0
jess.trevena-peters@monash.edu
Contact person for scientific queries
Name 69592 0
Prof Jennie Ponsford
Address 69592 0
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria
Country 69592 0
Australia
Phone 69592 0
+61 3 9905 1552
Fax 69592 0
Email 69592 0
jennie.ponsford@monash.edu

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