[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07638748":3,"trial-entities:NCT07638748":113,"trial-summary:NCT07638748":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":62,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":81,"locations":84,"central_contacts":104,"overall_officials":108,"references":111,"see_also_links":112},"NCT07638748","HSC-MS-26-0038","Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment","Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment (VR-MCI)","NOT_YET_RECRUITING","2026-11-30","2026-06","2026-06-10","2026-06-12","The University of Texas Health Science Center, Houston","OTHER",null,"The purpose of this study is to demonstrate feasibility, usability, and acceptability of VR-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and functional outcomes",[18,19],"Mild Cognitive Impairment","Subjective Cognitive Decline (SCD)",[21,22,23],"Virtual Reality","Cognitive Rehabilitation","Physical Rehabilitation","INTERVENTIONAL","DEVICE_FEASIBILITY",[27],"NA",{"count":29,"type":30},10,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","VR sessions","Participants will complete 3 supervised VR sessions using the Real System™ VR headset, per week for 6 weeks, for a total of 18 sessions. Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks",[34],[38,41,43,45,49,52,56,58,60],{"measure":39,"timeFrame":40},"Feasibility as assessed by the recruitment rate","from baseline to end of intervention (6 weeks)",{"measure":42,"timeFrame":40},"Feasibility as assessed by the retention rate",{"measure":44,"timeFrame":40},"Feasibility as assessed by the session completion rate",{"measure":46,"description":47,"timeFrame":48},"Usability as assessed by the System Usability Scale (SUS)","The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess participants' perceived usability of the intervention. each rated on a 5-point Likert scale from 1 = Strongly Disagree, 2 = Disagree 3 = Neutral ,4 = Agree, 5 = Strongly Agree. Scores range from 0 to 100, with higher scores indicating greater usability.","Post-intervention only (Final visit at 6 weeks)",{"measure":50,"description":51,"timeFrame":48},"Acceptability \u002F Presence as assessed by the Presence Questionnaire (PQ)","This is a 29 item questionnaire, each is scored on a seven-point Likert-type scale with a score range form 29-203. Higher scores indicate a greater sense of presence or immersion in the virtual environment.",{"measure":53,"description":54,"timeFrame":55},"Tolerability \u002F Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ)","This is a 16 item questionnaire and each is scored form 0(none) to 3(severe). Scores are combined using weighted subscales to generate a total score, with higher scores indicating greater simulator sickness","Before + immediately After each VR session",{"measure":57,"timeFrame":48},"Adherence \u002F Engagement as assessed by the session attendance as entered in VR system logs",{"measure":59,"timeFrame":48},"Adherence \u002F Engagement as assessed by the time from start to end of VR session as entered in VR system logs",{"measure":61,"timeFrame":48},"Adherence \u002F Engagement as assessed by the number of repetitions of the activity as indicated by device metrics",[],"ALL","55 Years","90 Years",false,{"inclusion":68,"exclusion":74,"raw_text":80},[69,70,71,72,73],"Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)","Capacity to provide informed consent","Able to provide own transportation to sessions","Speaks and understands English","Ambulatory",[75,76,77,78,79],"Uncontrolled seizures or epilepsy","Severe psychiatric illness or active suicidality","Inability to follow instructions or tolerate VR (severe motion sickness)","Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)","Any condition that the research team determines would interfere with safe participation","Inclusion Criteria:\n\n* Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)\n* Capacity to provide informed consent\n* Able to provide own transportation to sessions\n* Speaks and understands English\n* Ambulatory\n\nExclusion Criteria:\n\n* Uncontrolled seizures or epilepsy\n* Severe psychiatric illness or active suicidality\n* Inability to follow instructions or tolerate VR (severe motion sickness)\n* Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)\n* Any condition that the research team determines would interfere with safe participation",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":101},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Seema Aggarwal, PhD, APRN, AGNP-C","CONTACT","(713) 500-9946","Seema.S.Aggarwal@uth.tmc.edu",{"name":98,"role":94,"phone":99,"email":100},"Tela Todd","(713) 500-7039","Tela.Todd@uth.tmc.edu",{"lat":102,"lon":103},29.76328,-95.36327,[105,107],{"name":106,"role":94,"phone":95,"email":96},"Seema S Aggarwal, PhD, APRN, AGNP-C",{"name":98,"role":94,"phone":99,"email":100},[109],{"name":93,"affiliation":13,"role":110},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":117},[115,116],"Mild cognitive disorder","Subjective Cognitive Decline",[],{"nct_id":4,"found":66,"summary":15,"prompt_version":15}]