Clinical trial NCT03933475: Telerehabilitation for Cognitive Impairment Following Acquired Brain Injury
Official title: A Feasibility Study of Telerehabilitation in East Riding for Patients With Cognitive Impairment Following Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Brain Injuries
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2019-05-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre and post intervention study
Primary purpose: TREATMENT

Brief summary: Cognitive function is the mental action or process of acquiring knowledge and understanding through thought, experience, and the senses. Cognitive impairment describes a noticeable decline in cognitive function which can be temporary or permanent. This decline is measurable and ranges from mild to severe depending on the degree of decline in function. Cognitive impairment can be caused by a variety of diseases or conditions, and it is not limited to a specific age group. It can occur in patients following acquired brain injury such as traumatic brain injury and stroke. Some causes of cognitive impairment are related to health issues that may be treatable, such as medication side effects, vitamin B12 deficiency, and depression. Cognitive impairment has a significant impact on rehabilitation outcome and quality of life. It has significant health and economic impact. People with cognitive impairment report three times longer stay in hospital compared to people hospitalised for other conditions.

Cognitive rehabilitation is the process by which cognitive function can be improved and reduces the impact of cognitive impairment. Cognitive rehabilitation helps to improve functional outcomes and quality of life of patients with cognitive impairment. Current cognitive rehabilitation protocols use face to face interaction which cannot optimise the intensity of therapy due a lack of resources. Many areas of UK do not have dedicated cognitive rehabilitation service, programme or personnel and where it exists, the service is restricted largely to the urban centres. These services have high patient to staff ratio with prolonged waiting times often extending over 12 months to access input. Innovative technologies with telemedicine may well bridge the gap in service provision, improve engagement and offer opportunities in resource management.

Gamification refers to the application of typical elements of game playing (e.g. point scoring, competition with others, rules of play) to other areas of activity (such as healthcare) to encourage engagement and motivation. It is increasingly being used in rehabilitation and provides a means of developing more effective treatments and interventions. Practice and repetition are key rehabilitation processes that can be enhanced through the use of gamified innovative technology.

This protocol describes a trial of an innovative rehabilitation tool for community dwelling adults with cognitive impairment following acquired brain injury. The intervention is a novel interactive system connected to a television set using 3D cameras and tailored software to deliver therapeutic activities to patients within their homes. Each participant will be required to have 2 sessions per week using the device. Each session will last about 20 minutes with 4 different activities of 5 minutes duration each, targeting different domains of cognitive function. Follow up assessments will be carried out after 12 weeks of using the equipment.

The primary outcome measure will be the change in the assessment scores on the cognitive tests administered before and after undergoing the rehabilitation programme. Secondary outcomes on quality of life, participation in leisure time activities and satisfaction with the use of the equipment will also be obtained. Safety while using the device will be monitored and any side effects from engaging in the activities will also be monitored.

Detailed description: The aim of the project is to explore the feasibility and effectiveness of using a telerehabilitation system to improve cognitive function in recruited study participants of community dwelling adult patients (over 18 years) with cognitive impairment secondary to acquired brain injury.

The study objectives are:

1. To investigate the feasibility through a pilot programme of utilising a telerehabilitation system to deliver cognitive rehabilitation to a cohort of East Yorkshire community dwelling patients within their home environment.
2. To investigate the feasibility that a cohort of community dwelling patients with post acquired brain injury cognitive impairment can participate in a 12-week duration therapy programme using a telerehabilitation system designed to improve domains of cognitive function (attention, reaction times, memory and executive function).
3. To investigate whether health related quality of life (HRQOL) is improved in study participants taking part in a 12-week programme of using a cognitive telerehabilitation system.
4. To investigate whether leisure time physical activity in increased in the study participants.

These study objectives will be achieved through measurement of the following outcome parameters:

1. Administering the Godin leisure time exercise questionnaire (Godin LTQ). This is a self-report paper-based questionnaire that will be administered pre and post intervention.
2. The HRQOL of patients with cognitive impairment following acquired brain injury as measured by the following self-report paper-based questionnaires: European quality of life -5 dimension (EQ-5D), fatigue severity scale (FSS) and the Short form 12 (SF-12). Mood will be assessed with the hospital anxiety and depression scale (HADS). These questionnaires will be administered pre and post intervention.
3. A user satisfaction questionnaire will be administered following the intervention as a measure of acceptance and satisfaction with engaging in guided self-rehabilitation through the use of telerehabilitation technology. This will be administered in the post intervention assessment only.
4. Baseline cognitive screening using the Montreal Cognitive Assessment (MoCA) test to determine suitability for the intervention.
5. Assessment of cognitive function of patients before and after the telerehabilitation intervention by administering the following questionnaires:

   1. Trail making and colour word interference subtests of the Delis-Kaplan Executive Function Systems (D-KEFS).
   2. Walking While Talking (WWT) - Executive Function test.
   3. The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS). This is a screening measure that assesses: Immediate and delayed memory, Attention, Language and Visuospatial/Constructional skills.
   4. The Speed of Information Processing Subtests from the BIRT Memory and Information Processing Battery (BMIPB). This measures an individual's capacity for information processing, as well as their motor speed.

Study design The study design is a prospective pre-post intervention study aimed at evaluating cognitive rehabilitation in a sample of patients with cognitive impairment following acquired brain injury. The study primarily seeks to validate the feasibility of using purposefully designed videogames-based virtual reality technology to improve cognitive function in patients with cognitive dysfunction following acquired brain injury.

Recruited participants will undergo baseline assessments of cognitive function, leisure time activity, health related quality of life before engaging in a 12-week telerehabilitation programme using the Intendu functional brain trainer. Post intervention assessment using the same outcome measures administered in the baseline assessment will be performed 1 week after completion of the therapy programme.

The total duration of involvement for each participant is anticipated to be 14 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years)
* Clinical diagnosis of non-progressive Acquired brain injury cognitive Impairment.
* Must be able to stand independently for 20 minutes.
* Must be living in their own accommodation.
* Not involved in any ongoing clinical research.
* Must be able to communicate in English

Exclusion Criteria:

* Clinical diagnosis of photosensitive seizure disorders.
* Clinical diagnosis of Dementia

Primary outcomes:
measure: Cognitive Function: Memory, Attention, Language and Visuospatial skills
timeFrame: 6 months
measure: Cognitive Function: Executive Function
timeFrame: 6 months
measure: Cognitive Function: Divided Attention
timeFrame: 6 months
measure: Cognitive Function: Information processing speed
timeFrame: 6 months
Secondary outcomes:
measure: Health related quality of life (HRQOL)
timeFrame: 6 months
measure: Health related quality of life (HRQOL): Fatigue
timeFrame: 6 months
measure: Health related quality of life (HRQOL): General health measure
timeFrame: 6 months
measure: Health related quality of life (HRQOL): Mood
timeFrame: 6 months
measure: Participant Satisfaction with telerehabilitation intervention
timeFrame: 6 months
measure: Leisure Time Physical Activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)
state: East Yorkshire
Study officials:
References: