Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534164
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Telerehabilitation of Balance Clinical and Economic Decision Support System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telerehabilitation of Balance Clinical and Economic Decision Support System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TeleRehab DSS
Brief Summary:
Exercise has been shown to improve balance in older adults who are at risk for falls or those that have fallen in the past year Exercises are often provided as a standardised home exercise programme provided as a pamphlet for people to follow independently at home with routine check-ups Alternatively these exercises are provided in a community setting such as a falls clinic where exercises are done in groups supervised by a rehabilitation team 1-6 Many exercise programmes only provide basic balance and strengthening exercises to help reduce falls 2-5
Older adults or patients with stroke or mild memory problems mild cognitive impairment MCI may be at higher risk of falls 1-6 Individuals with chronic vestibular disorder which affects the vestibularbalance system long term or with long Covid are likely to report balance problems All such individuals may depend more on vision for balance and may have unpleasant feelings of blurred vision andor unsteadiness when walking 7-9 Customised exercise programmes can reduce these symptoms and have shown promise in reducing symptoms and improving balance 10
Although customised exercises may offer additional benefits compared with traditional programmes they are costly to run and require many face-to-face appointments with a physiotherapist Recent advances in technology have allowed a computerised exercise programme which can be done at home and record the performance with body-worn sensors 11 The programme provides instructions for the exercises and other tasks for example games by projecting a hologram a three-dimensional image into a participants room via a lightweight headset 11 This enables us to provide a personalised interactive programme that allows the physiotherapist to monitor the participants progress and change the exercises without visiting the participants physiotherapist 11
This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme11 TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors Further information is available at httpsholobalanceeu 11 HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote telerehabilitation balance physiotherapy programme It includes different multisensory balance and gait exercises physical activity and memory training and exergames video games which are also exercises to improve balance function in older adults The system can thus assess and remotely monitor how users are performing the exercises 11
This study TeleRehab DSS short for TeleRehabilitation Decision Support System aims to explore effectiveness including cost of running such programme in comparison with the current standard care for middle-ageolder adults with balance disordersfalls due to MCI vestibular disorders stroke or long Covid This study also aims to review treatment result risk of falls balance memory function - based on clinical tests and real-life sensor information and collect information about the programmes safety and performance while determining programme usability
This study involves human participants and each clinical site has applied for appropriate ethical approval
Older adults or patients with stroke or mild memory problems mild cognitive impairment MCI may be at higher risk of falls 1-6 Individuals with chronic vestibular disorder which affects the vestibularbalance system long term or with long Covid are likely to report balance problems All such individuals may depend more on vision for balance and may have unpleasant feelings of blurred vision andor unsteadiness when walking 7-9 Customised exercise programmes can reduce these symptoms and have shown promise in reducing symptoms and improving balance 10
Although customised exercises may offer additional benefits compared with traditional programmes they are costly to run and require many face-to-face appointments with a physiotherapist Recent advances in technology have allowed a computerised exercise programme which can be done at home and record the performance with body-worn sensors 11 The programme provides instructions for the exercises and other tasks for example games by projecting a hologram a three-dimensional image into a participants room via a lightweight headset 11 This enables us to provide a personalised interactive programme that allows the physiotherapist to monitor the participants progress and change the exercises without visiting the participants physiotherapist 11
This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme11 TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors Further information is available at httpsholobalanceeu 11 HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote telerehabilitation balance physiotherapy programme It includes different multisensory balance and gait exercises physical activity and memory training and exergames video games which are also exercises to improve balance function in older adults The system can thus assess and remotely monitor how users are performing the exercises 11
This study TeleRehab DSS short for TeleRehabilitation Decision Support System aims to explore effectiveness including cost of running such programme in comparison with the current standard care for middle-ageolder adults with balance disordersfalls due to MCI vestibular disorders stroke or long Covid This study also aims to review treatment result risk of falls balance memory function - based on clinical tests and real-life sensor information and collect information about the programmes safety and performance while determining programme usability
This study involves human participants and each clinical site has applied for appropriate ethical approval
Detailed Description:
This is an assessor-blinded researchers assessing the participants will not know what study group participants will be in randomised participants will join different study groups randomly controlled study Participants will be randomised using an online platform wwwsealedenvelopecom to undergo a home-based exercise programmes into either the intervention group IG or control group CG Participants will not be able to choose their preferred group and must be willing to participate in the assigned group
All study participants will attend two sessions at UCL The first assessment will be within one week prior to starting the programme and the second will be within one week of completing the programme Participants will be asked to complete a questionnaire set walkingbalance tests and a cognitive test approximately 25 hours duration including comfort breaks
The questionnaires ask about participants balance and confidence in their ability to maintain balance in everyday activities their mood physical activity levels and current health-status approximately 30 minutes
The balancewalking tests evaluate the participants balance during different walkingstanding conditions such as walking with head movement or standing on an uneven surface approximately 20 minutes
Through a computerised touch screen digital Montreal cognitive assessment on iPad the cognitive tests asses concentration memory and multi-tasking ability
Participants will receive telephone calls each week to monitor their progress Participants will also receive remote program reviews at weeks 3 6 and 9 from a member of the research team to assess and change exercises as required Participants will be advised to contact the research team by email or by telephone during working hours if they have concerns or questions about their rehabilitation program or the TeleRehab DSS system The research team will judge whether an additional home visit is required If a patient does not complete their exercises for three consecutive days a flagwarning will appear on the patients dashboard as a priority patient to follow up with within 24 hours
Intervention Group IG TeleRehab DSS The intervention TeleRehaB DSS group participants will be visited by a research team member to install the TeleRehab DSS system in their home and taught how to use the system with a practice session The system comprises a depth camera lightweight augmented reality headset that displays the hologram body-worn sensors that record movements and a heart rate sensor Participants will be required to wear all the equipment when performing the prescribed exercises A demo-video including equipment and hologram is available at wwwholobalanceeu Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians at weeks 3 6 and 9 which will be loaded into the participants programme At the end of the study participants will be invited to take part in an interview to discuss their experience with using the TeleRehab DSS system
The TeleRehaB DSS intervention includes HOLOBalance balance rehabilitation programme with a hologram It is based upon established evidence-based multi-sensory rehabilitation MSR protocols that can improve balance control in healthy older adults with exercises for the balance system if performed regularly over a period of time
Balance Physiotherapist Hologram BPH represents a virtual coach physiotherapist which provides personalised exercises and instructions for home balance training It also provides feedback on the individuals performance based on the information received from body-worn sensors and analysed using EDGE computer processing unit
The IG will receive the TeleRehaB DSS supported prescribed progressed and delivered intervention In the TeleRehaB DSS IG the platform will suggest two possible management strategies on an individualized basis based on patient profiles and expected benefit 1The high-tech full TeleRehaB DSS with all components of the intervention consisting of TeleRehaB DSS AI-progressed multisensory balance exercises with the use of the AR avatar real time feedback AR gamified intervention sensor monitored exercise performance and additional cognitive training 2 the low-tech basic version of TeleRehaB DSS with depth camera sensors and tablet - multisensory balance exercises real time feedback sensor monitored exercise performance and cognitive games with no exergames no smartwatch and no mobile phone The clinician can override the TeleRehab DSS group allocation decision if it is deemed unsafe The intervention will be delivered as a daily 5 days per week 12 weeks long home-based exercise programme prescribed by non-experts junior physiotherapist without vestibular expertise or non physio with DSS support and coaching
The HOLOBalance programme user instructions are available here httpsholobalanceeuholobalance-instructions-of-use
Control group CG
Control group participants will receive standard balance rehabilitation Stroke and mild cognitive impairment MCI participants will receive the OTAGO home exercise program while vestibular dysfunction and long covid-19 participants will receive the Menieres Dizziness Booklet program
1 OTAGO Home Exercise Programme HEP a balance exercise programme developed by a research group at University of Otago New Zealand 12 The OTAGO HEP will be provided to all individuals in the control arm who report fallsare at risk of falls The OTAGO group participants will receive a pamphlet with instructions for home exercises within the programme resistance bands and an exercise diary The OTAGO HEP booklet is available at httpswwwlivestrongerorgnzassetsUploadsacc1162-otago-exercise-manualpdf
2 Vestibular rehabilitation programme - for participants with problems chronic lasting 3 months dizzinessimbalance due to chronic vestibular disorder affecting the vestibular balance system or due to long Covid The vestibular rehabilitation group participants will receive a booklet with vestibular exercises which have been individualised based on the assessment by the research team member The exercise booklet is a validated and widely used intervention for vestibular disorder 17 This will be provided to all individuals in the control arm with chronic dizzinessimbalance 3 months without fallsrisk of falls FGA22 The booklet has descriptions and diagrams of the exercises and instructions on how to progress these as well as an exercise log available at httpswwwmenieresorgukfilespdfsbalance-retraining-2012pdf
All study participants will attend two sessions at UCL The first assessment will be within one week prior to starting the programme and the second will be within one week of completing the programme Participants will be asked to complete a questionnaire set walkingbalance tests and a cognitive test approximately 25 hours duration including comfort breaks
The questionnaires ask about participants balance and confidence in their ability to maintain balance in everyday activities their mood physical activity levels and current health-status approximately 30 minutes
The balancewalking tests evaluate the participants balance during different walkingstanding conditions such as walking with head movement or standing on an uneven surface approximately 20 minutes
Through a computerised touch screen digital Montreal cognitive assessment on iPad the cognitive tests asses concentration memory and multi-tasking ability
Participants will receive telephone calls each week to monitor their progress Participants will also receive remote program reviews at weeks 3 6 and 9 from a member of the research team to assess and change exercises as required Participants will be advised to contact the research team by email or by telephone during working hours if they have concerns or questions about their rehabilitation program or the TeleRehab DSS system The research team will judge whether an additional home visit is required If a patient does not complete their exercises for three consecutive days a flagwarning will appear on the patients dashboard as a priority patient to follow up with within 24 hours
Intervention Group IG TeleRehab DSS The intervention TeleRehaB DSS group participants will be visited by a research team member to install the TeleRehab DSS system in their home and taught how to use the system with a practice session The system comprises a depth camera lightweight augmented reality headset that displays the hologram body-worn sensors that record movements and a heart rate sensor Participants will be required to wear all the equipment when performing the prescribed exercises A demo-video including equipment and hologram is available at wwwholobalanceeu Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians at weeks 3 6 and 9 which will be loaded into the participants programme At the end of the study participants will be invited to take part in an interview to discuss their experience with using the TeleRehab DSS system
The TeleRehaB DSS intervention includes HOLOBalance balance rehabilitation programme with a hologram It is based upon established evidence-based multi-sensory rehabilitation MSR protocols that can improve balance control in healthy older adults with exercises for the balance system if performed regularly over a period of time
Balance Physiotherapist Hologram BPH represents a virtual coach physiotherapist which provides personalised exercises and instructions for home balance training It also provides feedback on the individuals performance based on the information received from body-worn sensors and analysed using EDGE computer processing unit
The IG will receive the TeleRehaB DSS supported prescribed progressed and delivered intervention In the TeleRehaB DSS IG the platform will suggest two possible management strategies on an individualized basis based on patient profiles and expected benefit 1The high-tech full TeleRehaB DSS with all components of the intervention consisting of TeleRehaB DSS AI-progressed multisensory balance exercises with the use of the AR avatar real time feedback AR gamified intervention sensor monitored exercise performance and additional cognitive training 2 the low-tech basic version of TeleRehaB DSS with depth camera sensors and tablet - multisensory balance exercises real time feedback sensor monitored exercise performance and cognitive games with no exergames no smartwatch and no mobile phone The clinician can override the TeleRehab DSS group allocation decision if it is deemed unsafe The intervention will be delivered as a daily 5 days per week 12 weeks long home-based exercise programme prescribed by non-experts junior physiotherapist without vestibular expertise or non physio with DSS support and coaching
The HOLOBalance programme user instructions are available here httpsholobalanceeuholobalance-instructions-of-use
Control group CG
Control group participants will receive standard balance rehabilitation Stroke and mild cognitive impairment MCI participants will receive the OTAGO home exercise program while vestibular dysfunction and long covid-19 participants will receive the Menieres Dizziness Booklet program
1 OTAGO Home Exercise Programme HEP a balance exercise programme developed by a research group at University of Otago New Zealand 12 The OTAGO HEP will be provided to all individuals in the control arm who report fallsare at risk of falls The OTAGO group participants will receive a pamphlet with instructions for home exercises within the programme resistance bands and an exercise diary The OTAGO HEP booklet is available at httpswwwlivestrongerorgnzassetsUploadsacc1162-otago-exercise-manualpdf
2 Vestibular rehabilitation programme - for participants with problems chronic lasting 3 months dizzinessimbalance due to chronic vestibular disorder affecting the vestibular balance system or due to long Covid The vestibular rehabilitation group participants will receive a booklet with vestibular exercises which have been individualised based on the assessment by the research team member The exercise booklet is a validated and widely used intervention for vestibular disorder 17 This will be provided to all individuals in the control arm with chronic dizzinessimbalance 3 months without fallsrisk of falls FGA22 The booklet has descriptions and diagrams of the exercises and instructions on how to progress these as well as an exercise log available at httpswwwmenieresorgukfilespdfsbalance-retraining-2012pdf
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None