Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Injuries
  • Cognitive Dysfunction
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pre and post intervention studyMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 objec...

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: 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. 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). 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. 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: 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 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. 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. Baseline cognitive screening using the Montreal Cognitive Assessment (MoCA) test to determine suitability for the intervention. Assessment of cognitive function of patients before and after the telerehabilitation intervention by administering the following questionnaires: Trail making and colour word interference subtests of the Delis-Kaplan Executive Function Systems (D-KEFS). Walking While Talking (WWT) - Executive Function test. 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. 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.

Tracking Information

NCT #
NCT03933475
Collaborators
Not Provided
Investigators
Not Provided