Trial Review

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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
8/01/2020
Date data sharing statement initially provided
8/01/2020
Date results provided
8/01/2020
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
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
Secondary outcome [5] 378568 0
Goal Attainment Scaling - goals developed for treatment condition participants and scored on a 5-point rating scale by clinicians. GAS scores then utilised by researcher to determine T-scores.
Timepoint [5] 378568 0
Scored at baseline and at PTA emergence (end of treatment period)
Secondary outcome [6] 378569 0
Qualitative interview themes emerging from semi-structured interviews conducted with occupational therapists administering the intervention.
Timepoint [6] 378569 0
One interview conducted with each therapist at least one year following involvement in delivery of the intervention.

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
Sex
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
* 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.
* We modelled the Functional Independence Measure total change from baseline as the primary outcome measure using random effects regression. Post-hoc analyses comparing group differences on Functional Independence Measure total change were computed at each time-point using a Bonferroni corrected alpha level. A reliable change index was calculated for Functional Independence Measure change (baseline to PTA emergence) using the reliability Functional Independence Measure motor scale and standard deviation of baseline Functional Independence Measure scores. Individuals were classified as reliably changing in the treatment period with a score at or above the reliable change index (7.44).
* Between group comparisons of secondary outcomes (PTA duration, length of stay, Community Integration Questionnaire) were conducted using t-tests with equal variance, with statistical significance set at 0.05.
* Data screening revealed 27.41% missing data for daily Agitated Behavior Scale agitation scores. Given this, the data were analysed in two ways: 1) using only complete observations (primary analysis); and 2) using multiple imputation to replace missing values on the Agitated Behavior Scale (secondary analysis). There were no differences between outcomes of the approaches.
* Goal Attainment Scaling T-scores were calculated (baseline and PTA emergence) and attainment for each scale summarised as above (+2, +1), at (0), or below the expected level (-1, -2). A t-test with equal variance compared baseline and PTA emergence (post-intervention) T-scores, and a Pearson product-moment correlation was computed to assess the relationship between T-scores and change in Functional Independence Measure at PTA emergence.
* Following therapist interviews, thematic content analysis was conducted to identify, analyse and report patterns of qualitative data. Analysis principally followed the phases described by Braun and Clarke (2006): 1. Transcripts reviewed and text segments identified by interpretative statements; 2. Initial codes generated, data coded systematically (manually) and similar content collated; 3. Codes organised into potential themes. Two other researchers reviewed coding and discussed theme development and member checking was conducted. 4. Themes were refined and defined and extracts selected.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
27/01/2017
Date of last data collection
Anticipated
Actual
28/04/2017
Sample size
Target
108
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6802 0
Epworth Richmond - Richmond
Recruitment hospital [2] 15582 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 14459 0
3121 - Richmond
Recruitment postcode(s) [2] 28967 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 294683 0
Government body
Name [1] 294683 0
Institute for Safety, Compensation, and Recovery Research (ISCRR)
Country [1] 294683 0
Australia
Funding source category [2] 294684 0
Charities/Societies/Foundations
Name [2] 294684 0
William Buckland Foundation
Country [2] 294684 0
Australia
Funding source category [3] 294685 0
Hospital
Name [3] 294685 0
Epworth Research Institute (ERI)
Country [3] 294685 0
Australia
Funding source category [4] 294686 0
University
Name [4] 294686 0
Monash Strategic Grant
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
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
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
[email protected]
Contact person for public queries
Name 69591 0
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
[email protected]
Contact person for scientific queries
Name 69592 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available in data dictionaries. We do not have ethical approval for this.


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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of Activities of Daily Living Retraining During Posttraumatic Amnesia: A Randomized Controlled Trial.2018https://dx.doi.org/10.1016/j.apmr.2017.08.486
N.B. These documents automatically identified may not have been verified by the study sponsor.