[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659225":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":50,"studyPopulation":43,"armGroups":51,"interventions":64,"overallOfficials":43,"centralContacts":73,"locations":79,"responsibleParty":93,"collaborators":97,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":69,"eligibilityCriteria":107,"healthyVolunteers":104,"sex":108,"minAge":109,"maxAge":43,"enrollmentInfo":110,"targetDuration":43,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":81,"whyStopped":43,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Canadian Occupational Performance Measure","The Canadian Occupational Performance Measure is a standardised client-centred outcome measure that assesses an individual's performance in daily activities (Law et al., 2005). This sensitive instrument focuses on participants' perceptions of their functioning and improvements in daily activities.","Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale","The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale assesses the non-motor and motor experiences of daily living and motor complications in People with Parkinson's Disease.",{"measure":18,"description":19,"timeFrame":12},"Kinesthetic and Visual Imagery Questionnaire-10","The Kinesthetic and Visual Imagery Questionnaire-10 will be used to assess motor imagery ability. It evaluates two dimensions of motor imagery: the clarity of visual imagery and the intensity of kinesthetic sensations associated with imagined movements. Participants first physically perform each movement and then imagine performing the same movement from a first-person perspective.",{"measure":21,"description":22,"timeFrame":12},"Color Trails Test","The Color Trails Test assesses a person's executive functioning and is considered a sensitive test for detecting different types of brain damage in PwPD (D'Elia et al., 1989). CTT1 evaluates a person's visual scanning, sequencing, and processing speed; and CTT2 adds an alternating sequence component and is sensitive to executive functions such as mental flexibility and divided attention.",{"measure":24,"description":25,"timeFrame":12},"Stroop Color and Word Test","The Stroop Color and Word Test assesses a person's mental flexibility - the ability to inhibit an automatic response and to establish and maintain a new, nonhabitual response based on environmental constraints.",{"measure":27,"description":28,"timeFrame":12},"Timed Up and Go test","The Timed Up and Go test is a standardised test that records the time taken by an individual to stand up from an armchair, walk 3 metres, turn and walk back at their usual speed, and sit on the chair again.",{"measure":30,"description":31,"timeFrame":12},"10-Meter Walk Test","The 10-Meter Walk Test is recommended to measure gait speed in people with Parkinson's disease and is proven to be a reliable and valid measure. Gait speed is measured in metres per second over the middle 6 metres.",{"measure":33,"description":34,"timeFrame":12},"European Quality of Life, Five Dimensions, Five Levels","The European Quality of Life, Five Dimensions, Five Levels instrument assesses five domains: mobility, self-care, usual activity, pain, and anxiety. Participants are asked to rate their self-perceived level of the five domains on a five-level scale of severity.",[36],{"measure":37,"description":38,"timeFrame":39},"Cortical Activity (mediator)","Participants will complete a paper-and-pencil neuropsychological test and daily activity-related mental imagery tasks. During the 10-second baseline period, participants are required to sit on a chair until the task begins. During the 30-second task period, they will be instructed to complete the tests.\n\nThe fNIRS recording session will be conducted in a quiet room. A 32-channel fNIRS optical topography system (NIRSport2; NIRx Medical Technologies, Berlin, Germany) will be utilised to monitor the oxygenation changes (i.e., oxy- to deoxy-hemoglobin proportion) in the cerebral cortices over the frontoparietal network (FPN), including the dorsolateral prefrontal cortex (DLPFC), ventrolateral prefrontal cortex (VLPFC), bilateral sensorimotor (SMC), bilateral premotor cortex (PMC), and bilateral supplementary motor area (SMA), throughout the Color Trails Test and daily activity-related mental imagery task paradigm.","Pre-intervention and at the end of the 6-week intervention",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":46,"maskingDescription":43,"whoMasked":47},"DOUBLE",[48,49],"PARTICIPANT","OUTCOMES_ASSESSOR","With less dopamine in the substantia nigra of the basal ganglia, People with Parkinson's Disease (PwPD) experience symptoms across a spectrum. This causes impairment of their supervisory attentional system (SAS), affecting the person's mental flexibility and ability to focus attention on movements and leading to a reliance on slow and energy-intensive action. As a result, PwPD have many restrictions not only in gait and walking but also in completing routine daily activities such as bathing and shopping.\n\nConventional rehabilitation, such as exercise, targets their motor issues and enhances mobility. However, exercise may not directly work on SAS impairment and non-motor symptoms and, therefore, may only produce short-term benefits. Cueing is another strategy that facilitates motor performance in PwPD by shifting attention resources to compensate for movement initiation and sequencing. Our previous systematic review and meta-analysis showed that cueing improved task performance in PwPD with a lasting effect from 1 week to 1 year. However, cueing relies on an external cue and device, which is unrealistic for daily and community living and specific to a particular task, such as walking. Generalisation to other daily activities is limited.\n\nThe use of Mental Imagery (MI) is a rehabilitation strategy that has been studied to improve function in PwPD. MI works under a cognitive mechanism that tackles the SAS impairment and improves the attentional focus required in learning movement strategies. However, conflicting results in the use of MI in PwPD have been found. When reviewing the intervention protocols of clinical trials with positive results, the intervention broke tasks into steps, engaged participants in self-awareness of their own problems, or drew attention toward task performance during mental imagery. Drawing attention toward task performance seems to work using a cognitive approach to tackle SAS impairment and improve the attentional focus required in learning movement strategies. Modification of MI intervention protocols by adding an extra component to enhance attentional focus when learning movement strategies and engaging them in understanding the motor demand based on their ability are hypothesised to be the key to guaranteeing the success of these MI intervention protocols. Self-regulation is a strategy that can offer this extra component.\n\nSelf-regulation has been used widely in education to enhance learning. It involves self-monitoring and self-modification of one's behaviour. In rehabilitation, self-regulation has been shown to enhance participation in daily activities in people with stroke. Using a cognitive approach, self-regulation is an active learning strategy that helps individuals to be aware of their own ability and environment and control their own learning. Self-regulation and executive function are connected theoretically and empirically. Both involve the processes of (1) organising\u002Fprioritising; (2) focusing\u002Fsustaining; (3) regulating alertness; (4) managing frustration and emotion; (5) utilising working memory and recalling; and (6) monitoring and self-regulating action. This is achieved by the person monitoring their own performance, identifying their solutions and reflecting on their success. Apart from people with stroke, the Principal Investigator and the team also demonstrated the effective use of self-regulation in autistic children in learning school and daily activities.\n\nOur previous studies demonstrated the effective use of MI with self-regulation in improving the daily activities in people with stroke, with 1-month carry-over effects and generalisation to untrained daily activities. Our research showed that combining MI with self-regulation could improve attention and sequencing-processing abilities and monitoring of daily activity performance by self-reflecting on successful performance in people with stroke. The cognitive processes in understanding one's abilities and deficits, analysing the demands in each step of a task, and planning and imagining performing the individual task steps will allow PwPD to process all the cognitive and motor demands as well as their own abilities in coping with these task demands.\n\nBased on our previous research on stroke, we developed a MI with self-regulation program for PwPD (MI-SeR) with feedback from two consumer co-designed workshops with five health professionals and five PwPD and their carers and pilot-tested it on 11 patients with mild to moderate PD. The MI-SeR was shown to have satisfactory feasibility (85% completed the intervention program) and excellent acceptability, with all participants who completed the program agreeing that they would recommend it to other PwPD. After the 6-week MI-SeR, there were significant improvements in patient-rated perceived daily activities and a medium effect size as measured by the Canadian Occupational Performance Measure (p = .011, effect size = .47), and attention and mental flexibility of cognitive function, also with medium effect sizes, as measured by the Trail Making A and Trail Making B, respectively (p ≤ .05, effect size = .59; p = .022, effect size = .69).\n\nObjectives\n\n1. Primary objective To investigate the effects of MI with self-regulation (MI-SeR), compared with conventional learning and exercise (control intervention), on improving patient-rated perceived performance of daily activities in PwPD.\n2. Secondary objective To assess the effects of the two interventions on daily functioning, cognitive function, and motor function in PwPD.\n3. Exploratory objective To explore whether MI-SeR is associated with changes in fNIRS-measured cortical haemodynamic responses during ADL-related MI tasks, and whether the intervention effects on daily activity performance are mediated through improvements in prefrontal executive function quantified by fNIRS-assessed cortical activity.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Mental imagery with self-regulation","EXPERIMENTAL","Participants will receive mental imagery training, self-regulation strategies. Training covers important daily activities (e.g., preparing breakfast, washing dishes, making phone calls), emphasizing task analysis, problem identification, solution development and implementation.",[57],"Other: Mental imagery with self-regulation",{"label":59,"type":60,"description":61,"interventionNames":62},"Exercise and health education","ACTIVE_COMPARATOR","Participants will receive exercise, including gross and fine motor exercises, and health education.",[63],"Other: Exercise and health education",[65,70],{"type":6,"name":53,"description":66,"armGroupLabels":67,"otherNames":68},"Participants will receive a 6-week program consisting of weekly 45-minute group sessions (2-4 participants per group), mental imagery training, self-regulation strategies, home practice, and telephone follow-up. Training covers important daily activities (e.g., preparing breakfast, washing dishes, making phone calls), emphasizing task analysis, problem identification, solution development and implementation.",[53],[69],"MI-SeR",{"type":6,"name":59,"description":71,"armGroupLabels":72,"otherNames":43},"Participants will receive a 6-week exercise and health education intervention, consisting of weekly 45-minute group sessions (2-4 participants per group), home practice, and telephone follow-up.",[59],[74],{"name":75,"role":76,"phone":77,"phoneExt":43,"email":78},"Karen P. Y. Liu","CONTACT","852 27665386","karen.liu@polyu.edu.hk",[80],{"facility":5,"status":81,"city":82,"state":43,"zip":43,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Hong Kong","HK",{"type":85,"coordinates":86},"Point",[87,88],114.17469,22.27832,{"lat":88,"lon":87},[91],{"name":75,"role":76,"phone":92,"phoneExt":43,"email":78},"852-27665386",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","LIU Karen","Professor",[98,100],{"name":99,"class":6},"Tung Wah Hospital",{"name":101,"class":6},"The University of Hong Kong-Shenzhen Hospital","100659225","effects-of-mental-imagery-with-self-regulation-on-daily-activities-in-people-with-parkinsons-disease-100659225",false,"NCT07860294","Effects of Mental Imagery With Self-regulation on Daily Activities in People With Parkinson's Disease","Inclusion Criteria:\n\n1. have been diagnosed with Parkinson's disease by a neurologist according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank, regardless of their age range;\n2. have Parkinson's disease with mild-to-moderate severity determined in the 'ON' phase, with scores of 1 to 3 on the Hoehn and Yahr scale;\n3. have been screened for intact attention and short-term memory functions by repeating all five words in the 'memory' question and scoring '1' (full marks) in forward order repeat in the 'read list of digits' in the 'attention' question of the Montreal Cognitive Assessment; and\n4. do not have depression, as indicated by scores less than 2 on the 4-item Geriatric Depression Scale\n\nExclusion Criteria:\n\n1. severe dyskinesia or severe ON-OFF motor fluctuations;\n2. stereotaxic brain surgery for Parkinson's disease;\n3. changes in dopamine therapy dose within 3 months before the study starts;\n4. disabling comorbidities such as cognitive disorders including stroke and depression; and\n5. language difficulties, unstable cardia or reparatory illness, or other medical conditions that may affect participation.","ALL","18 Years",{"count":111,"type":112},120,"ESTIMATED","INTERVENTIONAL",[115],"NA","The goal of this clinical trial is to learn whether mental imagery combined with self-regulation can improve daily activities in people with Parkinson's disease.\n\nThe main questions it aims to answer are:\n\n* Does mental imagery with self-regulation improve performance in daily activities?\n* Does it improve overall, cognitive, and motor function?\n\nResearchers will compare mental imagery with self-regulation with exercise and health education to assess their effects.\n\nParticipants will:\n\n* Complete a six-week mental imagery and self-regulation programme, conventional learning, or exercise.\n* Complete assessments of daily activities and overall, cognitive, and motor function.",[118],"Parkinson s Disease",[120,121,122,123,124],"Parkinson's disease","Daily activities","Early intervention","Mental imagery","Self-regulation","2026-09-30",{"date":127,"type":128},"2026-10-06","ACTUAL",{"date":130,"type":112},"2026-10-05",{"date":132,"type":112},"2028-12-31",{"name":5,"class":6},1]