[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658755":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":42,"interventions":55,"overallOfficials":33,"centralContacts":69,"locations":33,"responsibleParty":75,"collaborators":33,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":33,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":33,"overallStatus":97,"whyStopped":33,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":33},{"fullName":5,"class":6},"Cairo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Overall stability Index (OSI) by The Biodex balance system (BBS)","The test is commonly performed under both static and dynamic conditions, with the platform stability level adjusted (e.g., levels 8 to 1, where lower levels indicate greater instability). Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue. The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: the OSI reflects overall variance of platform displacement.","Baseline to 6 week post intervention",[14,17,21,24,27,30],{"measure":15,"description":16,"timeFrame":12},"Anterior-posterior stability index (APSI) by the biodex balance system","* Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue.\n* The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: the APSI represents sway in the sagittal plane (forward-backward)",{"measure":18,"description":19,"timeFrame":20},"The mediolateral stability index (MLSI) by the biodex balance system","* Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue.\n* The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: MLSI measures sway in the frontal plane (side-to-side).","Baseline to 6 weeks post intervention",{"measure":22,"description":23,"timeFrame":20},"Fall Risk Index (FRI) by the biodex balance system","Fall Risk Index (FRI) can be automatically calculated by the biodex balance system to quantify the individual's risk of falling. Higher values indicate greater instability and increased fall risk.",{"measure":25,"description":26,"timeFrame":20},"sensory integration by the Biodex balance system","The modified clinical test of sensory integration and balance (MCTSIB):-\n\n* Condition one: The patient stand on a firm surface with opened eyes and looked at a target on the display screen during platform tilt so incorporated visual, vestibular, and somatosensory inputs.\n* Condition two: The patient stood on a firm surface with closed eyes and eliminated visual input to evaluate vestibular and somatosensory inputs during platform tilt.\n* Condition three: The patient stood on a foam surface with opened eyes and looked at a target on the display screen during platform tilt to evaluate somatosensory interaction with visual input.\n* Condition four: The patient stands on a foam surface with closed eyes during platform tilt to evaluate somatosensory interaction with vestibular input.\n\nThe higher the sway index,the more unsteady the person was during the test. The patient performed three trials; the trial duration was 20 seconds with a rest period of 25 seconds.",{"measure":28,"description":29,"timeFrame":20},"Timed Up and Go (TUG)","* Participant is asked to stand up from a chair, walk three meters, turn, walk back, and sit down, while the time taken is recorded.\n* A cut-off score of 13.5 seconds in the Timed Up and Go (TUG) test is commonly used, where a time exceeding this value indicates an increased risk of falls.",{"measure":31,"description":32,"timeFrame":20},"The Berg Balance Scale","The Berg Balance Scale\n\n* patient is asked to perform tasks such as sitting unsupported, standing with eyes closed, reaching forward, turning, and transferring between positions.\n* Each task is scored on a 5-point ordinal scale (0-4) based on the patient's ability to complete the task independently, the time taken, and the level of assistance required. The total score ranges from 0 to 56.\n\nScores ranging from 41 to 56 indicate low fall risk and generally reflect independent mobility, while scores between 21 and 40 suggest a moderate fall risk with noticeable balance impairments and a potential need for assistance during activities. Scores from 0 to 20 represent a high fall risk and are associated with severe balance deficits and a high level of dependence.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Conventional physical Therapy Exercise","ACTIVE_COMPARATOR","Participants will receive 18 sessions over 6 weeks, 3 sessions per week. Each 60-minute session will consist of conventional physical therapy only.The intervention will consist of conventional physical exercise( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training).",[48],"Behavioral: The intervention will consist of conventional physical therapy exercise",{"label":50,"type":51,"description":52,"interventionNames":53},"Conventional physical Therapy Exercise + immersive VR","EXPERIMENTAL","Participants will receive 18 sessions over 6 weeks, 3 sessions per week. Each 60-minute session will consist of 30 minutes of immersive virtual reality-based exercise and 30 minutes of conventional physical therapy.The Immersive VR training which include Game-like interactive exercise. participant should hold two controllers. Game requires continuous anticipatory postural adjustments, frequentWeight shifting (left\u002Fright), trunk rotation, and mini squats which improve dynamic balance, reaction time, sensorimotor integration (visual + vestibular + proprioception), and postural muscle activation.",[48,54],"Behavioral: Immersive Virtual Reality",[56,63],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"BEHAVIORAL","The intervention will consist of conventional physical therapy exercise","( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training).",[44,50],[62],"Static and dynamic balance exercise",{"type":57,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Immersive Virtual Reality","Immersive virtual reality (IVR) uses head-mounted displays to place users inside interactive, 3D digital environments that actively train human postural control.VR-based interventions may improve sensory symptoms and postural stability without adverse effects. Studies have demonstrated that immersive VR training improves the integration of visual and proprioceptive information, leading to enhanced postural stability in individuals with balance impairments. Virtual reality technology has shown promising results in balance rehabilitation by providing interactive environments that enhance patient engagement and stimulate multisensory feedback mechanisms.",[50],[68],"Immersive VR",[70],{"name":71,"role":72,"phone":73,"phoneExt":33,"email":74},"Mariam Motie Elfouly","CONTACT","201060416864","mariammotie@gmail.com",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Mariam Motie Elsayed Elfouly","Principal investigator","100658755","effect-of-immersive-virtual-reality-on-postural-control-and-risk-of-fall-in-patients-with-chemotherapy-induced-peripheral-neuropathy-100658755",false,"NCT07854574","Effect of Immersive Virtual Reality on Postural Control and Risk of Fall in Patients With Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Forty female patients with chronic chemotherapy-induced peripheral neuropathy.\n* Duration of illness will be from 3 months to 1 year after completion of chemotherapy.\n* The patients age will be from 30 to 45.\n* BMI will be ranged from 25-29.9 kg\u002Fm2.\n* Patient with mild to moderate balance impairment Berg Balance Scale ( Score ranging from 21 to 56)\n* Patient with normal cognition ( Mini-Mental scale examination score of \\> 24 ).\n* Ambulant patients\n* Medically stable to participate In rehabilitation.\n\nExclusion Criteria:\n\nPatient will be excluded if they have one of the following:-\n\n* Neurological Disorders affecting postural control and risk of fall other than CIPN (Diabetic polyneuropathy, Multiple sclerosis , and Radiculopathy)\n* Any musculoskeletal disorders affecting balance ( Scoliosis, kyphosis, and fracture)\n* Vestibular disorders and Visual impairments affecting balance.\n* Pregnancy\n* Diabetes mellitus","FEMALE","30 Years","45 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"NA","Chemotherapy-induced peripheral neuropathy (CIPN) is a major cause of functional disability in cancer survivors. Patients with CIPN typically present with numbness, tingling, burning pain, and loss of proprioception, particularly in distal extremities. The sensory and motor deficits associated with CIPN impair balance and increase the likelihood of falls, which may lead to injury, decreased independence, and reduced quality of life. Loss of proprioception and vibration sense in CIPN disrupts sensory integration required for maintaining postural control. Consequently, individuals with CIPN often demonstrate gait instability, impaired balance, and increased sway during standing and walking tasks. Recent evidence suggests that immersive VR rehabilitation is feasible and safe for individuals with moderate to severe CIPN. Additionally, VR-based interventions may improve sensory symptoms and postural stability without adverse effects. Studies have demonstrated that immersive VR training improves the integration of visual and proprioceptive information, leading to enhanced postural stability in individuals with balance impairments. Virtual reality technology has shown promising results in balance rehabilitation by providing interactive environments that enhance patient engagement and stimulate multisensory feedback mechanisms. So, the purpose of the current study is to investigate the effect of immersive virtual reality on postural control and risk of fall in patients with chemotherapy-induced peripheral neuropathy.",[96],"CIPN - Chemotherapy-Induced Peripheral Neuropathy","NOT_YET_RECRUITING","2026-10-01",{"date":100,"type":101},"2026-10-05","ACTUAL",{"date":103,"type":90},"2026-11",{"date":105,"type":90},"2027-10",{"name":5,"class":6}]