[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05888441":3,"trial-entities:NCT05888441":93,"trial-summary:NCT05888441":96},{"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":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":17,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":69,"locations":72,"central_contacts":87,"overall_officials":90,"references":91,"see_also_links":92},"NCT05888441","16447","Obstacle Negotiation in Older People With and Without Vision Impairment","Impact of Stepping Over Obstacles of Different Contrast and Height on Gait and Eye Movements in Older Adults With and Without Vision Impairment","RECRUITING","2028-12-31","2025-11","2025-11-13","2023-04-14","Indiana University","OTHER",false,"Falls are common among people with vision impairment and can lead to devastating health consequences. Understanding the functions of vision and how the visual characteristics of obstacles in the walking path impact the gait of people with vision impairment is necessary to create strategies to prevent falls in this population. The purpose of this study is to determine how adults with vision impairment change their gait behavior when stepping over obstacles that vary in height and contrast to the ground. We will then determine the mechanisms of gaze behavior that correlate to the gait behavior.",null,[19],"Low Vision",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Obstacle characteristics","In the walking trials, when an obstacle is present, the obstacle height and obstacle contrast level will be varied across the trial repetitions.\n\nEach participant will be exposed to obstacles of two heights: the first will be 1 centimeter in height, and the second will be approximately 20% of the subject's leg length (ranging in physical height between 15 - 22 centimeters to cover a range of leg lengths in the population).\n\nObstacles (of both heights) will also be painted such that their measured luminance (or contrast) level against the floor luminance is varied. High contrast obstacles will have ≥80% Michelson contrast and low contrast obstacles will have ≤30% Michelson contrast.",[33,34],"Control Group","Low Vision Group",[36,40,43,46],{"measure":37,"description":38,"timeFrame":39},"Vertical foot clearance, lead limb","Distance from lowest point of foot (heel or toe) to top of obstacle","During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.",{"measure":41,"description":42,"timeFrame":39},"Foot placement variability","Standard deviation of position of toe to obstacle over 2-4 steps before the obstacle",{"measure":44,"description":45,"timeFrame":39},"Obstacle crossing speed","Speed from lead toe off immediately before the obstacle to trail heel down immediately after the obstacle.",{"measure":47,"description":48,"timeFrame":39},"Gaze sequencing","Sequence of fixations from start of trial to end of trial, normalized to the total duration and divided into 100 equal segments",[],"ALL","18 Years",true,{"inclusion":54,"exclusion":60,"raw_text":68},[55,56,57,58,59],"Age 18 or over","Able to walk independently","Either have normal vision, or impaired vision.","Impaired vision is defined as binocular visual acuity of 20\u002F25 or worse with or without a central scotoma; and\u002For binocular visual field that is restricted to an average of 100 degrees in diameter or less","Control subjects will have visual acuity of 20\u002F40 or better.",[61,62,63,64,65,66,67],"Not cleared by a medical provider for moderate physical activity","Self-report or have a history of: vestibular disorder or deafness","Medical history of any condition that affects the ability to walk for up to 2 hours with breaks, such as feeling dizzy or faint, chest pain, palpitations, pain or numbness in the legs, shortness of breath,","Cognitive limitations either by self-report or a score on the Mini Mental State Exam below 24 (out of 30)","Walking or gait abnormalities, such as those caused from an injury, surgery, severe arthritis, or neurological condition such as Parkinson's disease","Unable to walk without any walking aids such as a walker, cane, guide dog, or oxygen tank.","Does not speak English","Inclusion Criteria:\n\n* Age 18 or over\n* Able to walk independently\n* Either have normal vision, or impaired vision.\n\n  * Impaired vision is defined as binocular visual acuity of 20\u002F25 or worse with or without a central scotoma; and\u002For binocular visual field that is restricted to an average of 100 degrees in diameter or less\n  * Control subjects will have visual acuity of 20\u002F40 or better.\n\nExclusion Criteria:\n\n* Not cleared by a medical provider for moderate physical activity\n* Self-report or have a history of: vestibular disorder or deafness\n* Medical history of any condition that affects the ability to walk for up to 2 hours with breaks, such as feeling dizzy or faint, chest pain, palpitations, pain or numbness in the legs, shortness of breath,\n* Cognitive limitations either by self-report or a score on the Mini Mental State Exam below 24 (out of 30)\n* Walking or gait abnormalities, such as those caused from an injury, surgery, severe arthritis, or neurological condition such as Parkinson's disease\n* Unable to walk without any walking aids such as a walker, cane, guide dog, or oxygen tank.\n* Does not speak English",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"Bloomington","Indiana","47405","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Kierstyn A Napier-Dovorany, OD","CONTACT","812-855-4426","knapier@iu.edu",{"lat":85,"lon":86},39.16533,-86.52639,[88],{"name":80,"role":81,"phone":89,"email":83},"8128554426",[],[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[19],[],{"nct_id":4,"found":52,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll 200 participants. It will compare how people with normal vision and those with impaired vision navigate obstacles.","completed","Obstacle Negotiation in Older People With and Without Vision Impairment Study","This study is looking at how people with and without low vision (impaired vision) step over obstacles. Researchers want to understand how different obstacle heights and how much they stand out from the ground (contrast) affect walking. The goal is to learn more about how vision helps us avoid falls, especially for people with vision impairment. You might be able to join if you are 18 or older, can walk on your own, and have either normal vision or vision impairment. The study will measure things like how high you lift your foot, how steady your steps are, and how fast you cross obstacles during a single visit.","Not specified.",108,"You would participate in a single visit, lasting up to 2-3 hours, where you will walk over obstacles of different heights and contrast levels.","Not stated in the trial record.",[],"v2"]