[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553203":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":66,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Oslo Metropolitan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Visual Simulation (IVS)","EXPERIMENTAL","Treatment is performed by an IVS trained physiotherapists. Patients receive maximum 16 treatments over 2 months. In addition, all participants will undergo a baseline, an endpoint and a 2-month follow-up examination conducted by a physiotherapist. The treatment is individually adapted to the level of motor control in the phantom arm\u002Fleg and pain level of the individual participant.\n\nAn IVS treatment session consists of individualized exercises for the phantom arm\u002Fphantom leg with appropriate progression and adjustments.\n\nIn addition to IVS, all participants in the experimental group continues their routine medical care",[13],"Device: Intensive Visual Simulation (IVS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","All participants randomized to the control group undergo the same baseline and endpoint examinations as the experimental group. This group continues with their routine medical and non-medical care offered by their own doctor or other health professionals during the study period.The participants shall not start mirror therapy or IVS therapy during this period. Following endpoint examination, they are offered to start IVS treatment for a period of 8 weeks. After IVS treatment there is a 8 week follow up period.",[19],"Other: Usual Care (UC)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The IVS system initially makes a video-recording of the intact body part (arm or leg) executing a set of specific movements. These video recordings will be digitally reversed and projected onto a large screen in front of the patient. On the screen, the patient will monitor an intact, life-like extremity in place of the amputated extremity. This digital extremity will then execute the recorded movements in a pre-planned manner. Simultaneously, the patient will follow the digital virtual limb moving on the screen with his\u002Fhers amputated arm\u002Fleg, which is hidden below the screen. Hence, IVS therapy comprises elements of both movement perception, motor planning, motor execution and visual feedback of two intact limbs moving which are distinctive from classical Mirror-Therapy.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care (UC)","After allocation to UC, the participants continue with their normal treatment as prescribed by their medical doctor or other health professionals. All control participants are offered to complete IVS treatment after the end of the study period. The participants in the control group will therefore be placed on a fictitious \"waiting list\" during the study period.",[15],[31],{"name":32,"affiliation":5,"role":33},"Terje Gjøvaag, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Jens-Christian Trojel Hviid, MSci","CONTACT","+4794449140","jehvi7741@oslomet.no",{"name":32,"role":37,"phone":41,"phoneExt":25,"email":42},"+4795866979","terje@oslomet.no",[44],{"facility":5,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Oslo","0130","Norway","NO",{"type":51,"coordinates":52},"Point",[53,54],10.74609,59.91273,{"lat":54,"lon":53},[57,59,62,64],{"name":32,"role":37,"phone":41,"phoneExt":25,"email":58},"terje.gjovaag@oslomet.no",{"name":60,"role":37,"phone":25,"phoneExt":61,"email":39},"Jens-Christian T Hviid, MSci","+4794440140",{"name":63,"role":33,"phone":25,"phoneExt":25,"email":25},"Terje Gjøvaag Associate professor, PhD",{"name":36,"role":65,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100553203","treatment-of-phantom-limb-pain-by-intensive-visual-simulation-therapy-100553203",false,"NCT06483035","Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy","Intensive Visual Simulation as Treatment for Chronic Phantom Limb Pain in Persons With Upper or Lower Limb Amputation - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Unilateral or bilateral lower limb\u002Fupper limb amputees\n* Adults \\> 18 years of age, no age limit\n* A minimum of 12 months since amputation\n* Chronic PLP: \\> 6 months\n* PLP intensity: \\> 3 on the 0-10 VAS scale\n* Analgesic treatments must have been stable for the previous month\n* Stable prosthetic situation (ie, satisfaction with the fitting of the prosthesis) or being a non-user.\n* Adequate Norwegian language skills\n\nExclusion Criteria:\n\n* Significant visual impairment \u002F blind\n* Unable to follow instructions, i.e significant cognitive impairment.","ALL","18 Years",{"count":78,"type":79},38,"ESTIMATED","INTERVENTIONAL",[82],"NA","Phantom limb pain (PLP) is reported by as much as 80 % of patients following an amputation. There is increasing knowledge of the relation between PLP and maladaptive changes in brain cortical regions. Research has shown that the sight of an \"intact arm\" moving in a mirror may reverse maladaptions (Mirror-therapy, MT) and reduce PLP.\n\nThe current project will implement a digital and modernized version of MT, i.e. Intensive Visual Simulation Therapy (IVS-T). Pilot studies have shown promising results on pain reduction in people with phantom limb pain when using IVS-T. However, there is a lack of RCT studies on this patient population.\n\nThis study is a 2-arm randomized controlled trial (RCT) investigating the effectiveness of IVS-T compared with usual care in person with unilateral upper- or lower limb amputation with chronic phantom limb pain.\n\nThe primary aim of the study is to investigate if IVS treatment is superior to usual care in reducing phantom limb pain intensity after 2 months of treatment in unilateral amputees with moderate to severe PLP.\n\nThe study will furthermore explore quality of life, analgesic consumption, phantom pain characteristics, mobility, and disability. In addition, the study utilizes brain imagery during treatments to investigate neural plasticity and the association between PLP and maladaptive cortical changes.",[85],"Phantom Limb Pain",[87,88,89,90],"Amputation","Chronic pain","Intensive Visual Stimulation","RCT","2025-03-18",{"date":93,"type":94},"2025-03-21","ACTUAL",{"date":96,"type":94},"2024-09-05",{"date":98,"type":79},"2026-10",{"name":5,"class":6},1]