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临床试验/NCT03933475
NCT03933475已完成不适用

A Feasibility Study of Telerehabilitation in East Riding for Patients With Cognitive Impairment Following Acquired Brain Injury

Hull University Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Cognitive Function: Executive Function

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Cognitive Function: Executive Function

时间窗: 6 months

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.

Cognitive Function: Divided Attention

时间窗: 6 months

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.

Cognitive Function: Information processing speed

时间窗: 6 months

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.

Cognitive Function: Memory, Attention, Language and Visuospatial skills

时间窗: 6 months

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.

次要结局

  • 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)
  • Leisure Time Physical Activity(6 months)
  • Health related quality of life (HRQOL)(6 months)
  • Health related quality of life (HRQOL): Fatigue(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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