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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]

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

Post-traumatic amnesia

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Occupational therapy

Injuries and Accidents

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]

Treatment: Other

Intervention code [2]

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]

Functional Independence Measure (FIM)

Timepoint [1]

Admission to hospital (Epworth HealthCare)
PTA emergence
Discharge from hospital
2 month follow-up

Secondary outcome [1]

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]

Westmead PTA scale will be administered daily from admission until emergence from PTA.

Secondary outcome [2]

Length of inpatient stay measured measured by days form hospital admission until discharge

Timepoint [2]

Discharge

Secondary outcome [3]

Community Integration Questionnaire (CIQ)

Timepoint [3]

2 month follow-up

Secondary outcome [4]

Agitated Behaviour Scale (ABS)

Timepoint [4]

Daily during PTA

Secondary outcome [5]

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]

Scored at baseline and at PTA emergence (end of treatment period)

Secondary outcome [6]

Qualitative interview themes emerging from semi-structured interviews conducted with occupational therapists administering the intervention.

Timepoint [6]

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?

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]

Epworth Richmond - Richmond

Recruitment hospital [2]

Epworth Rehabilitation Camberwell - Camberwell

Recruitment postcode(s) [1]

3121 - Richmond

Recruitment postcode(s) [2]

3124 - Camberwell

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Institute for Safety, Compensation, and Recovery Research (ISCRR)

Address [1]

Institute for Safety, Compensation, and Recovery Research (ISCRR)
222 Exhibition St, Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

William Buckland Foundation

Address [2]

ANZ Charitable Trusts Services ANZ Executors & Tr
Level 2, 575 Bourke St
Melbourne, Vic 3000

GPO Box 2307
Melbourne, VIC 3001

Country [2]

Australia

Funding source category [3]

Hospital

Name [3]

Epworth Research Institute (ERI)

Address [3]

89 Bridge Road, Richmond VIC 3121

Country [3]

Australia

Funding source category [4]

University

Name [4]

Monash Strategic Grant

Address [4]

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]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Epworth HealthCare Ethics Committee

Ethics committee address [1]

Mailbox #4
89 Bridge Road Richmond, Vic 3121

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/05/2013

Ethics approval number [1]

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

Trevena-Peters, J., McKay, A., Spitz, G., Suda, R., Renison, B., & Ponsford, J. (2018). Efficacy of Activities of Daily Living Retraining During Posttraumatic Amnesia: A Randomized Controlled Trial. Arch Phys Med Rehabil, 99(2), 329-337 e322. doi:10.1016/j.apmr.2017.08.486

Trevena-Peters, J., Ponsford, J., & McKay, A. (2018). Agitated behavior and activities of daily living retraining during posttraumatic amnesia. The Journal of head trauma rehabilitation, 33(5), 317-325. doi:10.1097/HTR.0000000000000363

Trevena-Peters, J., McKay, A., & Ponsford, J. (2018). Activities of daily living retraining and goal attainment during posttraumatic amnesia. Neuropsychological Rehabilitation, 1-16. doi:10.1080/09602011.2018.1441033

Trevena-Peters J, McKay A, Spitz G, Suda R, Ponsford J. Efficacy of activities of daily living retraining during posttraumatic amnesia. Presented at: The 12th World Congress on Brain Injury; 2017 Mar 30 - Apr 1; New Orleans, US.

Trevena-Peters J, McKay A, Suda R, McMahon Z, Ponsford J. Evaluating outcomes of skills retraining during posttraumatic amnesia using goal attainment scaling. Presented at: The 12th World Congress on Brain Injury; 2017 Mar 30 - Apr 1; New Orleans, US.

McKay A, Trevena-Peters J, Ponsford J. Agitation during post traumatic amnesia: Characteristics, predictors, and impact on therapy. Presented at: The 12th World Congress on Brain Injury; 2017 Mar 30 - Apr 1; New Orleans, US.

Trevena-Peters J, McKay A, Spitz G, Suda R, Ponsford J. Efficacy of activities of daily living retraining during posttraumatic amnesia: A randomised controlled trial. Presented at: The 40th Annual Brain Impairment Conference; 2017 Jun 1-3; Melbourne, AU.

Trevena-Peters J, McKay A, Suda R, McMahon, Z. Ponsford J. Evaluating outcomes of skills retraining during posttraumatic amnesia using goal attainment scaling. Presented at: The 40th Annual Brain Impairment Conference; 2017 Jun 1-3; Melbourne, AU.

McKay A, Trevena-Peters J, Ponsford J. Agitation during post traumatic amnesia: Characteristics, predictors, and impact on therapy. Presented at: The 40th Annual Brain Impairment Conference; 2017 Jun 1-3; Melbourne, AU.

Trevena-Peters J, Ponsford J, McKay A,. Agitated behaviour, therapy participation and activities of daily living retraining during posttraumatic amnesia. Presented at: The 41st Annual Brain Impairment Conference; 2018 May 3-5; Adelaide, AU.

Trevena-Peters j, Ponsford J, McKay A, Spitz G, Suda R, Oliver J, Research Report Treatment in Posttraumatic Amnesia, July 2017

Trevena-Peters j, Ponsford J, McKay A, Spitz G, Suda R, Oliver J, Research Report Treatment in Posttraumatic Amnesia, March 2018

Related:

Roberts CM, Spitz G, Ponsford JL. Comparing Prospectively Recorded Posttraumatic Amnesia Duration With Retrospective Accounts. J Head Trauma Rehabil. 2016 Mar-Apr;31(2):E71-7. doi: 10.1097/HTR.0000000000000154. Epub 2015 Jun 19.
Bayley MT, Tate R, Douglas JM, Turkstra LS, Ponsford J, Stergiou-Kita M, Kua A, Bragge P. INCOG guidelines for cognitive rehabilitation following traumatic brain injury: methods and overview. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):290-306. doi: 10.1097

Ponsford J, Janzen S, McIntyre A, Bayley M, Velikonja D, Tate R. INCOG recommendations for management of cognition following traumatic brain injury, part I: posttraumatic amnesia/delirium. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):307-20. doi: 10.1097/HTR

Ponsford J, Bayley M, Wiseman-Hakes C, Togher L, Velikonja D, McIntyre A, Janzen S, Tate R. INCOG recommendations for management of cognition following traumatic brain injury, part II: attention and information processing speed. J Head Trauma Rehabil. 201

Tate R, Kennedy M, Ponsford J, Douglas J, Velikonja D, Bayley M, Stergiou-Kita M. INCOG recommendations for management of cognition following traumatic brain injury, part III: executive function and self-awareness. J Head Trauma Rehabil. 2014 Jul-Aug;29(4

Togher L, Wiseman-Hakes C, Douglas J, Stergiou-Kita M, Ponsford J, Teasell R, Bayley M, Turkstra LS. INCOG recommendations for management of cognition following traumatic brain injury, part IV: cognitive communication. J Head Trauma Rehabil. 2014 Jul-Aug;

Velikonja D, Tate R, Ponsford J, McIntyre A, Janzen S, Bayley M. INCOG recommendations for management of cognition following traumatic brain injury, part V: memory. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):369-86. doi: 10.1097/HTR.0000000000000069.

Roberts CM, Spitz G, Ponsford JL. Retrospective analysis of the recovery of orientation and memory during posttraumatic amnesia. Neuropsychology. 2015 Jul;29(4):522-9. doi: 10.1037/neu0000178. Epub 2015 Jan 26.

McKay A, Love J, Ponsford J. Agitation during post-traumatic amnesia and its association with disorientation and impairments of memory. Presented at: the 5th INS/ASSBI Pacific Rim Conference; 2015 Jul 1-4; Sydney, AU.

McKay A, Love J, Ponsford J. Agitation during post-traumatic amnesia and its association with disorientation and impairments of memory. Presented at: the 12th Conference of the Neuropsychological Rehabilitation Special Interest group of the World Federation

Ponsford JL, Spitz G, McKenzie D. Using post-traumatic amnesia to predict outcome following traumatic brain injury. J Neurotrauma. 2016 Jun 1;33(11):997-1004. doi: 10.1089/neu.2015.4025. Epub 2015 Oct 13.

Public notes

Contacts

Principal investigator

Name

Prof 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

Country

Australia

Phone

+61 3 9905 1552

Fax

jennie.ponsford@monash.edu

Contact person for public queries

Name

Jessica Trevena-Peters

Address

Monash Epworth Rehabilitation Research Centre (MERRC)
Ground Floor, 185-187 Hoddle Street,
Richmond, Vic, 3121

Country

Australia

Phone

+61 3 9426 8923

Fax

jessica.trevena-peters@monash.edu

Contact person for scientific queries

Name

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

Country

Australia

Phone

+61 3 9905 1552

Fax

jennie.ponsford@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Efficacy of Activities of Daily Living Retraining During Posttraumatic Amnesia: A Randomized Controlled Trial.	2018	https://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.

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