Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534177
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Digital Diagnostics and Intervention Services for Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Digital Diagnostics and Intervention Services for Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
People with Parkinsons have infrequent clinical consultation once every 12-18 months and limited rehabilitation
Assessment play an important role in these consultations to help clinicians understand patients health status and disease progression necessary to adjust treatment plans The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes There is a strong need for more frequent and accurate Parkinsons assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly There is a need to develop good home digital physiotherapy tools to increase the amount of therapy Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home The investigators aim to conduct a clinical study with 50 people with Parkinsons 50 from UK with the UPDRS a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinsons disease and 30 healthy adults The investigators will develop and investigate if two new digital devices one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS motor using digital gait and ophthalmic features in the clinic setting The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community
Assessment play an important role in these consultations to help clinicians understand patients health status and disease progression necessary to adjust treatment plans The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes There is a strong need for more frequent and accurate Parkinsons assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly There is a need to develop good home digital physiotherapy tools to increase the amount of therapy Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home The investigators aim to conduct a clinical study with 50 people with Parkinsons 50 from UK with the UPDRS a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinsons disease and 30 healthy adults The investigators will develop and investigate if two new digital devices one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS motor using digital gait and ophthalmic features in the clinic setting The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community
Detailed Description:
Diagnosis The current state of the art in diagnosing PD primarily revolves around clinical assessments based on symptomatology and neurological examination The most widely used criteria for diagnosis are Movement Disorder Society MDS criteria and instrument ie The MDSUPDRS These criteria are highly dependent on the expertise of the diagnosing physician and thus are subject to variability Furthermore these clinical assessments are unable to accurately track disease progression over time making it difficult to provide personalized care
Assessment plays an important role in these consultations to help clinicians understand patients health status and disease progression necessary to adjust treatment plans Current clinical methods rely on the UPDRS a standard clinical outcome measure that requires clinical expertise and training and is thus measured at clinical appointments
Further information may be gained from patients subjective description of their symptoms andor via some short walking tests such as 3 meter Timed Up and Go TUG performed as a snapshot in the clinic However patients vary through and between days and subjective descriptions rely on their memory and observations at home These recollections can be unreliable or lack enough detail particularly when the patient has cognitive impairment Walking tests although quick to perform show high variability due to natural fluctuations of the Parkinsons symptoms throughout the day onoff medication status as well as the performing effects when doing activities in a clinical setting Consequently Parkinsons care regimes are often provided on a trial-and-error basis with resulting general delay in offering care with early signs of disease progression often missed until conditions become more severe and interventions such as physiotherapy are often provided too late Hence there is a strong need for more frequent and accurate Parkinsons assessments in a real-world environment to enable more targeted care and preventative measures and interventions via early detection of disease inflection points Here the investigators propose to evaluate three digital approaches to see if they provide further information to support clinical decision making using gait and ophthalmic features The current state-of-the-art in neurological diagnostics includes a range of traditional clinical examination techniques such as manual neuro-ocular and neuro-motor function assessments as well as more technologically advanced tools such as imaging technologies eg MRI and electrophysiological tests eg ECG While these methods have undoubtedly contributed to significant advances in the detection and management of neurological disorders they also present several limitations that digital approaches overcome Traditional examinations of neurological function such as manual assessments UPDRS are heavily reliant on the expertise and subjective judgment of specialized neurologists This leads to known inconsistencies in interpreting and scoring patient performance over time particularly in the case of neurodegenerative diseases like Parkinsons disease PD where patients typically consult different resident neurologists over several years
Additionally manual examinations lack precise measurement instruments resulting in a low precision of observed measurements typically 2 cm and the inability to detect early-stage subclinical signs PD is a complex and progressive neurodegenerative disorder with significant variability in clinical manifestations and disease progression
Its diagnosis and monitoring remain a challenge primarily relying on clinical examinations that are subjective and often do not capture the full extent of symptom fluctuations
Intervention
Enabling independent living for an ageing society is a key challenge for the UK and other developed countries The number of patients with LTCs are increasing and already have the greatest healthcare needs of the population requiring 50 of all GP appointments and 70 of all bed days and their treatment and care absorbs 70 of acute and primary care budgets in England Maintaining safe mobility is a critical factor affecing life quality and life roles and responsibilities Considering Parkinsons alone an analysis has shown that 1 in every 37 people will be diagnosed with PD in their lifetime 2 FOG and FSG are severely debilitating aspects of the disease which greatly reduce the quality of life of PwP and contribute to the two-fold increased fall risk and related injuries 2 It is vital that The investigators provide a solution to support PwP with a more fluid and safe gait greater independence and better disease management and care Cueing with visual auditory or somatosensory stimuli is a well-documented and clinically validated method to overcome FOG IRAS Form Reference IRAS Version 636
Date
8 340549166576337423 and FSG Research studies have also shown that cueing modalities improve gait in PwP during both free and treadmill walking whilst improving balance and reducing the need for stabilising support Gait parameters such as step frequency stride length and gait symmetry have been shown to be measurable with inertial motion sensors for gait quality assessment Studies have shown that objective measurement of the disease can improve treatment outcomes in PD There are basic visual and rhythmic cueing products available such as laser shoes a metronome app and a vibrational button however they are still based on simple continuous cues which have profound limitations on usability and effectiveness in the everyday environment and do not include gait analytics systems to facilitate better patient outcome and experience The gaitQ system will be the first unique solution that uses artificial intelligence and smart adaptive cueing to help patients effectively overcome FOG and FSG in their daily environment while improving gait quality A prior proof-of-concept academic study run at the University of Oxford in 2019 prior to gaitQ company formation evaluated responsive vibration cueing using 17 patients over 31 hours in a clinical setting This study demonstrated that responsive cueing can reduce FOG and improve gait quality More recently NIHR i4i Connect funding completed in November 2021 enabled gaitQ to advanced its research device to a commercial prototype and conduct in-house product evaluation with 22 PwP 91 of participants reported a positive impact of the gaitQ device it helped prompt leg movement increase focus during walking maintain pace and boost confidence in walking The quantitative analysis of gait metrics has shown around 60 reduction of FOG and FSG events in both duration and occurrence Moreover participants stride length increased by 11 while step frequency decreased by 16 both are key outcomes towards more natural and stable walking Our machine learning algorithms have been tested against two Parkinsons studies achieving an average of 87 sensitivity and 85 specificity Ongoing validation in the lab is further determining the validity and reliabiity of the gait metric and estimating the effect of the cuing on transfers and mobility and enduriance
Assessment plays an important role in these consultations to help clinicians understand patients health status and disease progression necessary to adjust treatment plans Current clinical methods rely on the UPDRS a standard clinical outcome measure that requires clinical expertise and training and is thus measured at clinical appointments
Further information may be gained from patients subjective description of their symptoms andor via some short walking tests such as 3 meter Timed Up and Go TUG performed as a snapshot in the clinic However patients vary through and between days and subjective descriptions rely on their memory and observations at home These recollections can be unreliable or lack enough detail particularly when the patient has cognitive impairment Walking tests although quick to perform show high variability due to natural fluctuations of the Parkinsons symptoms throughout the day onoff medication status as well as the performing effects when doing activities in a clinical setting Consequently Parkinsons care regimes are often provided on a trial-and-error basis with resulting general delay in offering care with early signs of disease progression often missed until conditions become more severe and interventions such as physiotherapy are often provided too late Hence there is a strong need for more frequent and accurate Parkinsons assessments in a real-world environment to enable more targeted care and preventative measures and interventions via early detection of disease inflection points Here the investigators propose to evaluate three digital approaches to see if they provide further information to support clinical decision making using gait and ophthalmic features The current state-of-the-art in neurological diagnostics includes a range of traditional clinical examination techniques such as manual neuro-ocular and neuro-motor function assessments as well as more technologically advanced tools such as imaging technologies eg MRI and electrophysiological tests eg ECG While these methods have undoubtedly contributed to significant advances in the detection and management of neurological disorders they also present several limitations that digital approaches overcome Traditional examinations of neurological function such as manual assessments UPDRS are heavily reliant on the expertise and subjective judgment of specialized neurologists This leads to known inconsistencies in interpreting and scoring patient performance over time particularly in the case of neurodegenerative diseases like Parkinsons disease PD where patients typically consult different resident neurologists over several years
Additionally manual examinations lack precise measurement instruments resulting in a low precision of observed measurements typically 2 cm and the inability to detect early-stage subclinical signs PD is a complex and progressive neurodegenerative disorder with significant variability in clinical manifestations and disease progression
Its diagnosis and monitoring remain a challenge primarily relying on clinical examinations that are subjective and often do not capture the full extent of symptom fluctuations
Intervention
Enabling independent living for an ageing society is a key challenge for the UK and other developed countries The number of patients with LTCs are increasing and already have the greatest healthcare needs of the population requiring 50 of all GP appointments and 70 of all bed days and their treatment and care absorbs 70 of acute and primary care budgets in England Maintaining safe mobility is a critical factor affecing life quality and life roles and responsibilities Considering Parkinsons alone an analysis has shown that 1 in every 37 people will be diagnosed with PD in their lifetime 2 FOG and FSG are severely debilitating aspects of the disease which greatly reduce the quality of life of PwP and contribute to the two-fold increased fall risk and related injuries 2 It is vital that The investigators provide a solution to support PwP with a more fluid and safe gait greater independence and better disease management and care Cueing with visual auditory or somatosensory stimuli is a well-documented and clinically validated method to overcome FOG IRAS Form Reference IRAS Version 636
Date
8 340549166576337423 and FSG Research studies have also shown that cueing modalities improve gait in PwP during both free and treadmill walking whilst improving balance and reducing the need for stabilising support Gait parameters such as step frequency stride length and gait symmetry have been shown to be measurable with inertial motion sensors for gait quality assessment Studies have shown that objective measurement of the disease can improve treatment outcomes in PD There are basic visual and rhythmic cueing products available such as laser shoes a metronome app and a vibrational button however they are still based on simple continuous cues which have profound limitations on usability and effectiveness in the everyday environment and do not include gait analytics systems to facilitate better patient outcome and experience The gaitQ system will be the first unique solution that uses artificial intelligence and smart adaptive cueing to help patients effectively overcome FOG and FSG in their daily environment while improving gait quality A prior proof-of-concept academic study run at the University of Oxford in 2019 prior to gaitQ company formation evaluated responsive vibration cueing using 17 patients over 31 hours in a clinical setting This study demonstrated that responsive cueing can reduce FOG and improve gait quality More recently NIHR i4i Connect funding completed in November 2021 enabled gaitQ to advanced its research device to a commercial prototype and conduct in-house product evaluation with 22 PwP 91 of participants reported a positive impact of the gaitQ device it helped prompt leg movement increase focus during walking maintain pace and boost confidence in walking The quantitative analysis of gait metrics has shown around 60 reduction of FOG and FSG events in both duration and occurrence Moreover participants stride length increased by 11 while step frequency decreased by 16 both are key outcomes towards more natural and stable walking Our machine learning algorithms have been tested against two Parkinsons studies achieving an average of 87 sensitivity and 85 specificity Ongoing validation in the lab is further determining the validity and reliabiity of the gait metric and estimating the effect of the cuing on transfers and mobility and enduriance
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