Clinical Trials Logo

Clinical Trial Summary

This study aims to explore whether feedback from a physical monitoring device (electronic watch) to prompt patients to use an anxiety management strategy can help prevent challenging behaviour.


Clinical Trial Description

A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases.

Participants will wear the portable monitoring device with heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.

Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03260335
Study type Interventional
Source University of Glasgow
Contact
Status Withdrawn
Phase N/A
Start date November 2017
Completion date June 2018

See also
  Status Clinical Trial Phase
Completed NCT03911752 - Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Not yet recruiting NCT05863897 - e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury N/A
Completed NCT02215590 - Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims 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
Recruiting NCT04586842 - Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury N/A
Completed NCT03328221 - Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury
Active, not recruiting NCT05729165 - Local Vibration in Patients With Severe Acquired Brain Injury N/A
Active, not recruiting NCT05734183 - Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness N/A
Recruiting NCT05440682 - Connectivity in Cranioplasty N/A
Completed NCT04206475 - Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj. N/A
Recruiting NCT02495558 - Cough Assessment in Patients With Severe Acquired Brain Injury N/A
Completed NCT03989388 - Occupational Self-Analysis Programme N/A
Terminated NCT01974635 - Proprioception Testing in Persons With Sensorimotor Impairment N/A
Not yet recruiting NCT01451242 - The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER N/A
Not yet recruiting NCT06058351 - ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury N/A
Completed NCT05052905 - VR-based Remote Rehabilitation for Pediatric ABI N/A
Recruiting NCT06130735 - Impact of Intensive Computerized Cognitive Training N/A
Recruiting NCT04328857 - Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing N/A