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Trial of smart home, mobile or wearable assistive technology used by people with Acquired Brain Injury

Piloting the efficacy of assistive technology used for executive function support by people with Acquired Brain Injury: A single case experimental design case series

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000835741
Enrollment
15
Registered
2022-06-14
Start date
2022-06-20
Completion date
2024-05-01
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Acquired brain injury (ABI) frequently results in cognitive impairment in the domain of executive function. These issues can have significant impact on independence. There are a growing range of smart home, mobile and wearable technologies available that may address these needs. These technologies hold potential to improve level of independence and reduce the costs of care after ABI. However, evidence to select and guide their use to compensate for the functional impact of cognitive impairment is lacking. This study will evaluate the efficacy of assistive technology on executive function outcomes using a single-case experimental design protocol with a group of individuals with an ABI.

Interventions

Single-case experiments will be conducted in Victoria (N=10) and New South Wales (N=10) by a member of the research team to test the effectiveness of smart home, mobile and wearable assistive technologies used for executive function by people with Acquired Brain Injury (ABI). These single-case experiments will be planned by the research team to ensure scientific rigor, using the Risk of Bias in N-of-1 Trials Scale. The choice of design will be individualized to each participant, based on the spe

Single-case experiments will be conducted in Victoria (N=10) and New South Wales (N=10) by a member of the research team to test the effectiveness of smart home, mobile and wearable assistive technologies used for executive function by people with Acquired Brain Injury (ABI). These single-case experiments will be planned by the research team to ensure scientific rigor, using the Risk of Bias in N-of-1 Trials Scale. The choice of design will be individualized to each participant, based on the specific client goals and the best way to evaluate the uptake of the assistive technology. The most common design will be an A1-B1-A2-B2 withdrawal design. However, alternating treatments or multiple baseline may also be employed. Each phase will commence immediately after the preceding phase with no wash out period to minimize changes associated with natural recovery and other rehabilitation interventions administered as part of routine care. The individual intervention (Assistive Technology product) will be tailored to each individual, based on their personal goal for executive function support and participation in activities within home and community settings. Photos of the participants home environment will be taken by an occupational therapist in the research group. These will be used to help with discussions with the research team about potential considerations regarding the layout of the house for possible technology use. An occupational therapist in the research group will discuss the shortlist of assistive technologies, and in consultation with the participant (+/- their proxy, allied health professional) one will be selected for application. Technologies could include apps, wearables, home sensors, smart lights for example. The specified target behavior will therefore be tailored to each participant, and as such the measurement will also vary. Some anticipated examples are measurement of whether an identified activity (e.g. taking medication, brushing teeth) was completed or not and the frequency of successful / timely task completion (measured by completion of an activity log); and the effect of a prescribed Assistive Technology product (e.g. smartwatch with a schedule of timed alerts) in changing the number of verbal cues required from a support person (measured by completion of an activity log). The frequency of measurement of the target behavior will also vary depending on the target behavior being addressed for the individual participant, but they will all be measured at most daily and at least weekly. Each phase will include a minimum of five data points. The A 'baseline' phase will measure the target behavior and will serve as the control condition. The target behavior outcome will report whether an identified activity was completed or not, and the frequency of successful / timely task completion. For some technologies, it may be possible to use system-generated log reports, and as such, the technology will be set-up/installed (but will not be activated i.e. for reminders/prompts). If system-generated log reports are not possible, the technology will not be installed; rather a paper-based target behavior form will be completed by a proxy and used to collect data throughout all four phases. The B phase will be the ‘intervention’ phase where Assistive Technology (AT) will be installed, worn and/or activated. If required participants (+/- their proxy) will receive a single one-hour training session by an occupational therapist on how to use the technology. Any barriers to technology use will also be identified and ameliorated, if possible. For example, if the device is not effectively mounted on the participants’ wheelchair, the occupational therapist will conduct an assessment. They will then recommend/implement a solution to mount the device, prior to the start of the intervention phase. Measurement of the target behavior will be collected as per baseline phase, i.e. same duration, with a minimum of five data points. In the A2 ‘baseline’ phase, the technology will be uninstalled or deactivated. Measurement of the target behavior will be collected as per initial baseline phase, i.e. same duration, via proxy, with a minimum of five data points. In the B2 ‘intervention’ phase, the technology will be reinstalled, re-worn and/or re-activated. If required participants (+/- their proxy) will received another single one-hour training session by an occupational therapist on how to use the technology. Measurement of the target behavior will be collected as per baseline phase, (i.e., same duration, via proxy), with a minimum of five data points.

Sponsors

Transport Accident Commission (VIC)
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria comprise: (i) having sustained an ABI; (ii) being aged 18 years or over; (iii) living alone or with others, in a community dwelling in Victoria or New South Wales (metro / rural region); (iv) experiencing executive dysfunction (as measured by the Frontal Systems Behaviour Scale) and (v) have substantial support needs for everyday living (documented by a rating of level 4 or higher on the Care and Needs Scale). People who do not identify as either male or female (i.e. non-binary) will also be eligible to participate in the study.

Exclusion criteria

Exclusion criteria comprise: (i) current severe mental health problems (as documented on the HONOS-ABI, Fleminger et al, 2005) and (ii) challenging behaviors (as documented on the Overt Behavior Scale-Adult, Kelly et al., 2013).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026