Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000924550
Ethics application status
Approved
Date submitted
9/07/2024
Date registered
31/07/2024
Date last updated
31/07/2024
Date data sharing statement initially provided
31/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of i-RECOveR-TH: An interdisciplinary intervention for delayed recovery after concussion using telehealth
Scientific title
Pilot evaluation of Interdisciplinary REhabilitation for COncussion Recovery using TeleHealth (i-RECOveR-TH): Investigating the impact on concussion symptoms in individuals who have experienced a mild traumatic brain injury
Secondary ID [1] 312353 0
None
Universal Trial Number (UTN)
Trial acronym
i-RECOveR-TH: Interdisciplinary Rehabilitation for Concussion Recovey Using Telehealth
Linked study record
Parent study: ACTRN12620001111965

Health condition
Health condition(s) or problem(s) studied:
concussion 334126 0
persisting post-concussion symptoms 334127 0
traumatic brain injury 334128 0
mild traumatic brain injury 334129 0
Condition category
Condition code
Neurological 330801 330801 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 330802 330802 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 330803 330803 0 0
Physiotherapy
Injuries and Accidents 330804 330804 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician. Participants will be posted equipment packs to facilitate physiotherapy treatment via telehealth, including heart rate monitor, paddle pop sticks, laminated pages with numbers and checkers, and a ruler.

All participants will receive an initial 60–90-minute consultation with a neuropsychologist, physiotherapist, and medicine physician. The initial consultations will take place via telehealth using online video conferencing. Following initial consultations, clinicians will meet via case conference to discuss individualised treatment plans.

Participants will be offered up to an additional 7 sessions each of psychological and physiotherapy treatment as required based on the initial interviews. (i.e. A total of 16 sessions of treatment will be offered for physiotherapy and psychology). Treatment sessions will be delivered online via videoconference. Psychological treatment sessions will last between 60-90 minutes at a maximum of once a week. Physiotherapy treatment sessions will last for 45-60 minutes and will be at a maximum of once a week. Participants will also be offered ongoing medical management/review/consultations as required via telehealth over the 8-week program.

The psychological intervention will be oriented toward a cognitive-behavioural framework as described by Beck (1979) and will be adapted from previous manuals developed by Ferguson and Mittenberg (1996) and Silverberg et al. (2013) and will comprise of goal setting and review, psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, cognitive compensation intervention and sleep intervention. As part of this therapy, participants will be provided with educational materials adapted from readily available resources (published materials such as the Mild Head Injury Bookelet; https://www.monash.edu/medicine/psych/merrc/resources) as well as provided with material specially designed for this study.

Participants will also be assessed by a physiotherapist and will be provided treatment in the following domains as required: ocular, vestibular, cervical, and autonomic system functioning. Physical therapy intervention will be specific to their assessment and may comprise of vestibular rehabilitation, manual therapy, cervical strengthening, proprioceptive training, and a graded exercise program. Examples of ocular retraining include convergence exercises where participants will watch a target as it moves towards them, saccadic retraining where participants quickly move their gaze between targets, and smooth pursuit training where the participant watches a moving target. Examples of vestibular rehabilitation are gaze stabilisation where participants turn their head and focus on a target (this is done to a particular speed predetermined by the physiotherapy assessing the participant), VOR cancellation exercises where participants watch a target move through space by turning their whole body, and motion sensitivity exercises such as, walking, and gaze stabilisation or VOR cancellation. Examples of cervical rehabilitation include cervical strengthening such as deep neck flexor strengthening, and proprioception training with a target and a laser to rehabilitate sensory awareness of the neck. Graded exercise is defined as exercise of the participant's choice that can be safely done for 20 minutes. Exercise will be targeted at a particular heart rate. The starting heart rate will be defined as 85% of the point of failure of the subject on Montreal Virtual Exertion test. Heart rates will increase in line with a decrease in participant's symptoms. This will be assessed and closely monitored by the physiotherapist. Graded exercise will generally be walking, running or stationary bike, however, other modes such as swimming could be introduced if tolerated and preferred by the participant. The physiotherapist will outline an individualised treatment and home program based on the assessment. Equipment used throughout the assessment and rehabilitation include various targets (a paddle pop, sticky labels), balls for motion sensitivity and a heart rate monitor for tracking heart rate.

Medical management of persistent post-concussion symptoms will comprise of one consultation (same as initial consultation) with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school).

Treatment fidelity:
Adherence to the manualised CBT intervention will be rated by an independent psychologist who will listen to audio/video recordings of 10% of the sessions. To assess physiotherapy treatment fidelity, 10% of the sessions will be rated by an independent physiotherapist.
Intervention code [1] 328848 0
Rehabilitation
Intervention code [2] 328849 0
Treatment: Other
Comparator / control treatment
No control group. This study will be a single case series experimental design with multiple baselines. Participants' results on key outcome measures will be compared at the start of baseline, before the intervention, after the intervention and at one and two-month follow-up.

Participants will be randomised to baseline periods of 2, 4, or 6 weeks. The efficacy of the intervention for reducing post-concussion symptoms will be evaluated using a case-series design with multiple baselines,
Control group
Active

Outcomes
Primary outcome [1] 338566 0
Post-concussion symptoms
Timepoint [1] 338566 0
Start of baseline (T1), Baseline, End of baseline (T2), Intervention, Post-intervention (T3), 1-month follow-up (T4), and 2-month follow-up (T5).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,

During baseline and intervention phases, participants will complete the Rivermead Post-Concussion Symptoms questionnaire 3 times a week via an online survey.
Secondary outcome [1] 436463 0
Return to activity
Timepoint [1] 436463 0
Intervention, Post-intervention (T3) and 1-month follow-up (T4)

GAS goals will be assessed multiple times within the intervention. GAS goals will be established in Session 2 of the psychological intervention. GAS goals will be reviewed weekly from Sessions 4-8 of the psychological intervention.

Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [2] 436465 0
Fatigue
Timepoint [2] 436465 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [3] 436466 0
Sleep disturbance
Timepoint [3] 436466 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).


Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [4] 436467 0
Health related quality of life
Timepoint [4] 436467 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [5] 436468 0
Symptoms of depression
Timepoint [5] 436468 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [6] 436469 0
Symptoms of anxiety
Timepoint [6] 436469 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [7] 436470 0
Symptoms of stress
Timepoint [7] 436470 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [8] 436471 0
Fear avoidance behaviours
Timepoint [8] 436471 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [9] 436983 0
Telehealth Usability
Timepoint [9] 436983 0
Post-Intervention (T3)

Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [10] 436994 0
Vestibular and oculomotor functioning will be assessed together as a composite outcome
Timepoint [10] 436994 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [11] 436995 0
Static Postural Stability
Timepoint [11] 436995 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [12] 436996 0
Cervical functioning
Timepoint [12] 436996 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [13] 436997 0
Physiological Functioning
Timepoint [13] 436997 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [14] 436998 0
Cervical Impairment
Timepoint [14] 436998 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4).

Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion,

Eligibility
Key inclusion criteria
Eligibility criteria: (a) aged 16 – 70 years, (b) sustained a mTBI classified using the most recent diagnostic criteria developed by the American Congress of Rehabilitation Medicine (ACRM), (c) experiencing more than three post-concussion symptoms assessed by the Rivermead Post-Concussion Questionnaire (RPQ; King et al., 1995), in line with the International Statistical Classification of Diseases definition of pPCSs, (d) experiencing post-concussion symptoms for at least two weeks post-injury, but no more than two years post-injury, and (e) reside in a Modified Monash Model classification 2-6 in Victoria, Australia.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current acute psychiatric condition, active substance abuse, significant neurological history, and insufficient English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study uses a single case experimental design with multiple baselines.
Participants will be randomised into 1 of 3 baseline lengths (2, 4, or 6 weeks) using an online block randomisation method via https://www.random.org/lists/.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome measure. Systematic visual analysis of the RPQ will be conducted as per established guidelines in (Gast, D.L. and A.D. Spriggs, Visual analysis of graphic data, in Single case research methodology. 2014, Routledge. p. 176-210) incorporating both within- and between-phase analyses to evaluate trend, level, and stability of data. Planned comparisons between baseline and intervention phases will be conducted using the non-overlap method, Tau-U [Parker, R.I., et al., Combining nonoverlap and trend for single-case research: Tau-U. Behavior Therapy, 2011. 42(2): p. 284-299.]. Time series analyses will also be explored.

Secondary outcome measures. GAS goals will be descriptively explored [Perdices, M., How do you know whether your patient is getting better (or worse)? A user's guide. Brain Impairment, 2005. 6(3): p. 219-226.). Wilcoxon signed-rank test will be used to compare secondary outcome measures (BFI, FSS, ISI, HRQOL, FAB-TBI, DASS-21, VOMS, MOVE, SPNT, Flexion Rotation, BESS) across the four time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
2/09/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316761 0
University
Name [1] 316761 0
Monash Rehabilitation Ageing and Independent Living (RAIL) Research Centre
Country [1] 316761 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318973 0
None
Name [1] 318973 0
Address [1] 318973 0
Country [1] 318973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315529 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315529 0
Ethics committee country [1] 315529 0
Australia
Date submitted for ethics approval [1] 315529 0
28/03/2024
Approval date [1] 315529 0
23/04/2024
Ethics approval number [1] 315529 0

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

Contacts
Principal investigator
Name 134978 0
Dr Jack Nguyen
Address 134978 0
Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121
Country 134978 0
Australia
Phone 134978 0
+61 394268923
Fax 134978 0
Email 134978 0
jack.nguyen@monash.edu
Contact person for public queries
Name 134979 0
Jack Nguyen
Address 134979 0
Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121
Country 134979 0
Australia
Phone 134979 0
+61 394268923
Fax 134979 0
Email 134979 0
jack.nguyen@monash.edu
Contact person for scientific queries
Name 134980 0
Jack Nguyen
Address 134980 0
Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121
Country 134980 0
Australia
Phone 134980 0
+61 394268923
Fax 134980 0
Email 134980 0
jack.nguyen@monash.edu

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 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.