Brain Injuries Clinical Trial
— TRIEROfficial title:
A Feasibility Study of Telerehabilitation in East Riding for Patients With Cognitive Impairment Following Acquired Brain Injury
Verified date | February 2023 |
Source | Hull University Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 1, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust) | Cottingham | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull University Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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:
Walking - measure how many meters the participant walks, in 1 min (walk back and forth on a 10-meter section; instruct to turn around) Verbal fluency - while sitting down, count the number of words (excluding names and proper nouns), the participant says, beginning with a specific letter. 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 | |
Primary | 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 | Health related quality of life (HRQOL) | EQ-5D-5L: The European Quality of Life Measure 5 Dimensions-5 Levels (EQ-5D-5L) is a standardised measure of health-related quality of life that can be used in a wide range of health conditions and treatments. It consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. | 6 months | |
Secondary | Health related quality of life (HRQOL): Fatigue | FSS: The fatigue severity scale(FSS) is a 9-item tool that measures the severity of fatigue in a variety of conditions and its effects on an individual's activities and lifestyles. The FSS questionnaire comprises nine statements inquiring about the patient's usual way of life over the preceding week. Ratings are on a 7-point Likert scale, where higher scores indicate how strongly the patient agrees with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. The FSS has been accepted as a simple and reliable measure of fatigue. This tool also incorporates the VAFS (visual analogue fatigue scale) on a horizontal visual analogue scale. | 6 months | |
Secondary | Health related quality of life (HRQOL): General health measure | SF-12: The SF-12 is a multipurpose short form (SF) generic measure of health status. 12-Item Short Form Health Survey (SF-12) was designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. Two summary scores of health status, namely the physical component summary score (PCS) and the mental health summary score (MCS) can be derived from administering the tool. The scores on these two components are similar in magnitude and degree of change over time with values obtained using the longer version SF-36 questionnaire therefore making the SF-12 the instrument of choice where these 2 summary scores of health status are adequate. | 6 months | |
Secondary | Health related quality of life (HRQOL): Mood | HADS: The Hospital Anxiety and Depression Scale (HADS) is a popular and widely used well-validated measure of anxiety and depression in a general medical population of patients. A key advantage of the HADS is its simplicity, speed and ease of use. It assesses both anxiety and depression components which commonly co-exist using 7 domains on each component. Each domain has 4 descriptors with a score range 0-3 and a maximum total score of 21 possible for each component. Grade levels of mild, moderate and severe are defined by cut-off scores for each component. | 6 months | |
Secondary | Participant Satisfaction with telerehabilitation intervention | 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.
The user satisfaction questionnaire will be administered as part of the post intervention assessment to evaluate the views and opinions of the study participants with regards to using the Intendu Active Brain Trainer as part of their rehabilitation programme. This questionnaire has been developed for this study based on published evidence of the identified factors associated between telehealth and patient satisfaction. |
6 months | |
Secondary | Leisure Time Physical Activity | Leisure time physical activity behaviour will be evaluated by 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.The Godin leisure time questionnaire is a simple 3 item tool that has well established validity and reliability for assessment of leisure time behaviour and offering a means of examining changes in behaviour following implementation of health intervention programmes. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03400904 -
Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
|
||
Completed |
NCT06073145 -
Transcranial Doppler Using Wearable Ultrasound Patch
|
||
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
Not yet recruiting |
NCT05833568 -
Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness
|
N/A | |
Withdrawn |
NCT04288076 -
The Brain and Lung Interaction (BALI) Study
|
N/A | |
Not yet recruiting |
NCT02756585 -
Computed Tomography Perfusion in Patients With Severe Head Injury
|
N/A | |
Completed |
NCT03162484 -
Physical Activity and Chronic Acquired Brain Injury
|
N/A | |
Terminated |
NCT01430988 -
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|
N/A | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A | |
Completed |
NCT00975338 -
The LETS Study: A Longitudinal Evaluation of Transition Services
|
||
Completed |
NCT00878631 -
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
|
Phase 2/Phase 3 | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Not yet recruiting |
NCT04478812 -
Tbit System Precision and Correlation of Different Blood Samples
|
N/A | |
Recruiting |
NCT05309005 -
Virtual Reality and Social Cognition After Acquired Brain Injury
|
||
Recruiting |
NCT05443542 -
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
|
N/A | |
Completed |
NCT02702635 -
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
|
N/A | |
Withdrawn |
NCT04247321 -
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
|
N/A | |
Not yet recruiting |
NCT04386525 -
Omega 3 and Ischemic Stroke; Fish Oil as an Option
|
Phase 4 |