[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551366":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":29,"armGroups":38,"interventions":52,"overallOfficials":61,"centralContacts":65,"locations":71,"responsibleParty":88,"collaborators":29,"id":91,"slug":29,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":29,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":29,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Nicosia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"EuroQol 5 Dimension 5 Level","Measurement of quality of life. Likert scoring style (1-5) where higher scores represent worse state of quality of life","baseline, 4weeks follow up",{"measure":14,"description":15,"timeFrame":12},"The Short Form (12) Health Survey","Measurement of quality of life: The scores ranged from 0 to 100, where higher scores representing better quality of life",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Intrinsic Motivation Inventory","Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation",{"measure":21,"description":22,"timeFrame":12},"Mini Balance Evaluation Systems Test","Measurement of functionality and Balance: The scale's scores ranging from 0 to 28, where higher scores represent better functionality",{"measure":24,"description":25,"timeFrame":12},"Multidirectional Reach Test","Measurement of balance and functionality: Is the only scale that includes cm for the measurement of distance. Most healthy people present 25cm. People who present less than 18cm, indicates limitations on functional balance",{"measure":27,"description":28,"timeFrame":12},"Nine-Hole Peg Test","Measurement of fine motor skills and functionality: The test scores are based on the average duration of four trials. Healthy females present 17.9-19.6 second and males 19-20.6 seconds. Higher average duration indicates limited fine mobility",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","Parallel assignment of Randomized Control Trial","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":29},"NONE","Parkinson's disease is a chronic, neurodegenerative disease of unknown cause, affecting elderly people over the age of 60. It is the second most common neurodegenerative disease, presenting psychomotor signs and symptoms that lead to impaired functioning and quality of life in affected individuals. Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses, safely providing multiple iterations to carry out daily activities.\n\nThrough this tool and in collaboration with technologically skilled mixed reality developers, the software for the rehabilitation program to be applied to Parkinson's disease patients was also developed.\n\nThe main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation for people with Parkinson's disease.\n\nThe study will be divided into two phases, the first of which includes the translation and adaptation of the Intrinsic Motivation Inventory (IMI) questionnaire, which assesses motivation and is not available in Greek, and will be used in 300 healthy subjects to assess its psychometric characteristics.\n\nThe second phase of the clinical trial is a parallel, blinded, randomized study involving 45 patients.\n\nThis study will provide the opportunity to use innovative equipment that offers multiple stimuli increasing the interactivity of the participants to perform functional activities. This research is the first clinical study in Cyprus that will apply the reported rehabilitation tool aiming to improve and evaluate the quality of life, functionality and motivation of people with Parkinson's disease. Moreover, it enables the development of cognitive and motor rehabilitation by increasing the interaction of the individual with the environment and facilitating the completion of treatment goals.\n\nThe research using mixed reality and through a comparative process with traditional physiotherapy, aims to provide valid and reliable data to the general public and health scientists, facilitating the selection of appropriate means to provide a holistic treatment plan.\n\nTranslated with DeepL.com (free version)",[39,45,48],{"label":40,"type":41,"description":29,"interventionNames":42},"Mixed Reality interventional Group","EXPERIMENTAL",[43,44],"Other: Mixed Reality","Other: Traditional Physiotherapy",{"label":46,"type":41,"description":29,"interventionNames":47},"Traditional Physiotherapy Group",[43,44],{"label":49,"type":50,"description":29,"interventionNames":51},"Placebo group","PLACEBO_COMPARATOR",[43,44],[53,57],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":29},"Mixed Reality","The experimental group MR will use the mixed reality project involving activities in a supermarket. MR HoloLens2 glasses will be used to conduct the program. The technological equipment that will be used will allow the provision of visual and auditory stimuli. The program presents 5-10 different objects found in a supermarket, where you need, as you walk, to collect them within a mixed environment. This program offers coordination activities, posture, cognitive activities and balance exercises. The mixed reality program lasts 30 minutes, with a frequency of 3 times a week for 12 weeks.",[40,49,46],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"Traditional Physiotherapy","The group of traditional physiotherapy follows the guidelines of EPDA. Specifically, the program will be 35-40 minutes long, 3 times a week for 12 weeks. The program includes 5 minutes warm up, 10 minutes resistance exercises, 10 minutes of balance exercises and stretching.",[40,49,46],[62],{"name":63,"affiliation":5,"role":64},"Elena Papamichael, PhD Cand","PRINCIPAL_INVESTIGATOR",[66],{"name":63,"role":67,"phone":68,"phoneExt":69,"email":70},"CONTACT","99886346","00357","papamichael.e1@live.unic.ac.cy",[72],{"facility":5,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Nicosia","Engomi","2408","Cyprus","CY",{"type":80,"coordinates":81},"Point",[82,83],33.35397,35.17284,{"lat":83,"lon":82},[86,87],{"name":63,"role":67,"phone":68,"phoneExt":69,"email":70},{"name":63,"role":64,"phone":29,"phoneExt":29,"email":29},{"type":64,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Elena Papamichael","PhD Candidate in Physiotherapy","100551366",false,"NCT06459154","The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.","The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease. Randomized Control Trial","For the first interventional phase:\n\nInclusion Criteria:\n\n1\\. Male and female over 18 years old 2. Persons with independent gait 3. Normal cognitive ability 5. Greek Native language\n\nExclusion Criteria:\n\n1. Presence of neurological disease\n2. Presence of uncontrolled diseases of the circulatory system\n3. History of musculoskeletal surgery in the last 6 months\n4. Use of a walking aid\n5. Partial or total blindness\n\nFor the second interventional phase:\n\nInclusion Criteria:\n\n1. Male and female over 60 years old\n2. Persons with independent gait\n3. Normal cognitive ability\n\n5\\. Greek Native language\n\nExclusion Criteria:\n\n1. Presence of neurological disease\n2. Presence of uncontrolled diseases of the circulatory system\n3. History of musculoskeletal surgery in the last 6 months\n4. Use of a walking aid\n5. Partial or total blindness",true,"ALL","60 Years","100 Years",{"count":102,"type":103},15,"ESTIMATED","INTERVENTIONAL",[106],"NA","Parkinson's disease is a chronic, neurodegenerative disease of unknown cause, affecting elderly people over the age of 60. It is the second most common neurodegenerative disease, presenting psychomotor signs and symptoms that lead to impaired functionality and quality of life in affected individuals. Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses, safely providing multiple iterations to carry out daily activities.\n\nThrough this tool and in collaboration with technologically skilled mixed reality developers, the software for the rehabilitation program to be applied to Parkinson's disease patients was also developed.\n\nThe main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation of people with Parkinson's disease.",[109],"Parkinson Disease",[111,54,112,113,114],"PD","Physiotherapy","QOL","Motivation","2024-06-13",{"date":117,"type":118},"2024-06-14","ACTUAL",{"date":120,"type":118},"2023-08-20",{"date":122,"type":103},"2025-12-20",{"name":5,"class":6},1]