None listed
Conditions
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).
Interventions
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
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.
Sponsors
Professor Jennie Ponsford
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed