Telerehabilitation for Cognitive Impairment Following Acquired Brain Injury

NCT03933475 | Completed

• 1 other identifier: R2078
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Brain Injuries

Outcome Measures

Primary Outcomes (4)

• Cognitive Function: Memory, Attention, Language and Visuospatial skills

  RBANS: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides a brief individually administered battery of tests to assess neuropsychological status and ideal for measuring change over time. It can be used to track recovery during rehabilitation. It is a 30-minute screening test comprising 12 subtests that assesses 5 domains: immediate and delayed memory, attention, language and visuospatial/constructional skills. Subtest raw scores are converted to age-based index scores. In addition, a total scale can be calculated. Reliability coefficients for assessment of change as well as test-retest reliability are high for the total scale.

  6 months

• Cognitive Function: Executive Function

  DKEFS: The Delis-Kaplan Executive Function System (D-KEFS) measures verbal and non-verbal executive function in children and adults (ages 8-89 years). It comprises 9 tests each of which was designed as a standalone test. This study proposes to use some of the subtests namely; The Trail Making Test which measures flexibility of thinking on a visual-motor sequencing task and The Colour-Word Interference Test which measures ability to inhibit a dominant and automatic verbal response. The complexity of the tasks involved in administering the tests make them sensitive to the detection of even mild brain damage.

  6 months

• Cognitive Function: Divided Attention

  WWT: The Walking While Talking test is a dual-task measure of divided attention to examine cognitive motor interactions. Variations of the WWT test exists and for this study, the test will be administered as follows: 1. Walking - measure how many meters the participant walks, in 1 min (walk back and forth on a 10-meter section; instruct to turn around) 2. Verbal fluency - while sitting down, count the number of words (excluding names and proper nouns), the participant says, beginning with a specific letter. 3. Dual tasking - combine the two tasks. Measure how many words the participant says during 1 min, while walking. Note: use a different letter. Note: measure also the distance walked. The dual task motor cost (EF cost) is the difference in number of words generated between tests 2 and 3.

  6 months

• Cognitive Function: Information processing speed

  Brain injury rehabilitation trust Memory and Information Processing Battery (BMIPB) is a group of tests used in assessing the effects of the damage to the brain on memory and speed of information processing (SoIP). It can assist in planning individual rehabilitation programmes and also in evaluating recovery. The SoIP test will be used from the BMIPB battery. On this test, the individual has to work through rows of five 2-digit numbers, cancelling the second highest number in each row. The task lasts 4 minutes. The individual then undertakes a 25 second motor speed cancellation task. Scores are expressed as percentiles. The difference between the scores obtained at initial testing and that obtained at retest are standardised and expressed as T scores. The test has high test- retest and interrater reliability. There is no significant floor or ceiling effects and practice effects are substantially eliminated through the use of different versions for test-retest.

  6 months

Secondary Outcomes (6)

• Health related quality of life (HRQOL)

  6 months

• Health related quality of life (HRQOL): Fatigue

  6 months

• Health related quality of life (HRQOL): General health measure

  6 months

• Health related quality of life (HRQOL): Mood

  6 months

• Participant Satisfaction with telerehabilitation intervention

  6 months

Study Arms (1)

Intendu Active Brain Trainer Telerehabilitation Games

EXPERIMENTAL

Use of telerehabilitation Games within the home environment

Device: Virtual reality game

Interventions

Virtual reality game DEVICE

Use of virtual reality games on television screens

Intendu Active Brain Trainer Telerehabilitation Games

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pre and post intervention study

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 1, 2019
• Study Start: October 31, 2019
• Primary Completion: March 20, 2020
• Study Completion: September 1, 2020
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)