ANZCTR - Registration

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]

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

persisting post-concussion symptoms

traumatic brain injury

mild traumatic brain injury

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Physical Medicine / Rehabilitation

Physiotherapy

Injuries and Accidents

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]

Rehabilitation

Intervention code [2]

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]

Post-concussion symptoms

Timepoint [1]

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]

Return to activity

Timepoint [1]

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]

Fatigue

Timepoint [2]

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]

Sleep disturbance

Timepoint [3]

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]

Health related quality of life

Timepoint [4]

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]

Symptoms of depression

Timepoint [5]

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]

Symptoms of anxiety

Timepoint [6]

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]

Symptoms of stress

Timepoint [7]

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]

Fear avoidance behaviours

Timepoint [8]

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]

Telehealth Usability

Timepoint [9]

Post-Intervention (T3)

Post intervention will be defined as one-day post-intervention completion,

Secondary outcome [10]

Vestibular and oculomotor functioning will be assessed together as a composite outcome

Timepoint [10]

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]

Static Postural Stability

Timepoint [11]

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]

Cervical functioning

Timepoint [12]

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]

Physiological Functioning

Timepoint [13]

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]

Cervical Impairment

Timepoint [14]

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

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]

University

Name [1]

Monash Rehabilitation Ageing and Independent Living (RAIL) Research Centre

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

https://www.monash.edu/researchoffice/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2024

Approval date [1]

23/04/2024

Ethics approval number [1]

Summary

Brief summary

Concussion/mild traumatic brain injury represents a public health concern given its prevalence and potential long-term consequences, with up to 30% of people with concussion experiencing delayed recovery/persisting post-concussion symptoms (PPCSs). PPCSs can interfere with successful return to activities (e.g., school, work, sports) causing significant stress for months to years after injury. PPCSs are multifactorial and interdisciplinary treatments are recommended. 

Limited options for evidence-based interdisciplinary treatments exist, particularly in rural areas where concussion rates are higher. Our team of international leaders in concussion research, developed and piloted an Interdisciplinary Rehabilitation program for Concussion Recovery (i-RECOveR; ACTRN12620001111965) with positive results. Specialised interdisciplinary treatments such as i-RECOveR, however, are usually limited to urban cities and inaccessible in rural areas.

Telehealth can increase access to treatments such as i-RECOveR, although the evidence for telehealth concussion interventions is unestablished. As well as increasing access to treatments such as i-RECOveR, a telehealth model may assist with accessibility issues relating to the injury itself. Our previous research identified the potential benefit of telehealth which included eliminating the need to travel to appointments, which for some individuals with debilitating PPCSs, often exacerbated their symptoms compounding anxiety and fatigue.

In an Australian and possibly world first, this study will pilot an 8-week interdisciplinary intervention comprised of coordinated neuropsychology, physiotherapy and medical treatments via telehealth in 12 adults with PPCSs. Concussion symptoms will be assessed as well as treatment goal attainment. There is no comparator group. 

This research has the potential to establish a feasible, effective, and accessible intervention, increasing the reach of specialised concussion services to those living in rural and remote areas.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Jack Nguyen

Address

Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+61 394268923

Email

[email protected]

Contact person for public queries

Name

Jack Nguyen

Address

Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+61 394268923

Email

[email protected]

Contact person for scientific queries

Name

Jack Nguyen

Address

Monash-Epworth Rehabilitation Research Centre (MERRC) Ground Floor 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+61 394268923

Email

[email protected]

Trial Review

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Documents added automatically