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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Dysfunction Brain Injuries | Device: Virtual reality game | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Pre and post intervention study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Feasibility Study of Telerehabilitation in East Riding for Patients With Cognitive Impairment Following Acquired Brain Injury |
Estimated Study Start Date : | February 1, 2020 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Intendu Active Brain Trainer Telerehabilitation Games
Use of telerehabilitation Games within the home environment
|
Device: Virtual reality game
Use of virtual reality games on television screens
|
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:
The dual task motor cost (EF cost) is the difference in number of words generated between tests 2 and 3.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | May 1, 2019 | ||||
Last Update Posted Date | February 5, 2020 | ||||
Estimated Study Start Date ICMJE | February 1, 2020 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Telerehabilitation for Cognitive Impairment Following Acquired Brain Injury | ||||
Official Title ICMJE | A Feasibility Study of Telerehabilitation in East Riding for Patients With Cognitive Impairment Following Acquired Brain Injury | ||||
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:
These study objectives will be achieved through measurement of the following outcome parameters:
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Pre and post intervention study Masking: None (Open Label)Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Device: Virtual reality game
Use of virtual reality games on television screens
|
||||
Study Arms ICMJE | Experimental: Intendu Active Brain Trainer Telerehabilitation Games
Use of telerehabilitation Games within the home environment
Intervention: Device: Virtual reality game
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2020 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03933475 | ||||
Other Study ID Numbers ICMJE | R2078 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Hull University Teaching Hospitals NHS Trust | ||||
Study Sponsor ICMJE | Hull University Teaching Hospitals NHS Trust | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Hull University Teaching Hospitals NHS Trust | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |