[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720700":3,"trial-entities:NCT07720700":91,"trial-summary:NCT07720700":95},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":45,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":88,"references":89,"see_also_links":90},"NCT07720700","STU-2020-0059","Impact of Foot Orthoses on Gait in Individuals With Ataxia","Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses","RECRUITING","2027-12","2026-07","2026-07-22","2025-11-21","University of Texas Southwestern Medical Center","OTHER",false,"This study is the first to assess the impact of lower extremity orthoses on gait and balance in individuals with CA. By investigating how orthoses influence mobility and stability, this research will provide critical data to inform clinical guidelines, improve patient care, and support evidence-based orthotic prescriptions for individuals with CA.","This study is the first randomized controlled trial to evaluate the impact of orthoses on the gait and balance of individuals with ataxia. Prior studies have suggested that foot orthoses may provide stability to improve lower extremity mechanics2, 3 by potentially reducing degrees of freedom3 or by enhancing proprioceptive feedback12, 13, yet no clinical trials have systematically tested these effects in CA, a population with unique joint kinematics and sensory integration challenges. In general, there is a paucity of literature for individuals with CA.14 However, there are many neurologic diagnoses that find orthoses to be beneficial for balance,5, 15, 16 gait,17, 18 and functional mobility.19",[19],"Ataxia",[19,21,22],"Orthoses","Gait","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},20,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Home wearing schedule","Participants will wear the orthoses at home and record the time",[36,37],"Custom orthoses","Off the shelf",[39,43],{"measure":40,"description":41,"timeFrame":42},"Zeno Walkway","This is kinematic gait information including gait velocity.","Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.",{"measure":40,"description":44,"timeFrame":42},"This measures kinematic data such as step length.",[46,49],{"measure":47,"description":48,"timeFrame":42},"6 MWT","This test measures submaximal aerobic functional walking capacity. Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes.",{"measure":50,"description":51,"timeFrame":52},"Quebec User Evaluation of Satisfaction with Assistive Technology (survey)","This is a self-reported outcome measure that will be done at the last testing time point to assess participant considerations (ease of use for device, participant observations, perceived improvements in QOL). A higher score indicates higher levels of satisfaction.","After 14 days after wearing the orthosis.","ALL","18 Years",null,{"inclusion":57,"exclusion":61,"raw_text":65},[58,59,60],"Cerebellar ataxia diagnosed by a physician","Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)","18 years or older",[62,63,64],"Gait velocity \\>\u002F= 100 cm\u002Fsec without an assistive device","Medically diagnosed orthopedic conditions or injuries that impact ambulation","Unhealed wounds on the feet","Inclusion Criteria:\n\n* Cerebellar ataxia diagnosed by a physician\n* Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)\n* 18 years or older\n\nExclusion Criteria:\n\n* Gait velocity \\>\u002F= 100 cm\u002Fsec without an assistive device\n* Medically diagnosed orthopedic conditions or injuries that impact ambulation\n* Unhealed wounds on the feet",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"UT Southwestern Medical Center","Dallas","Texas","75235","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Staci M Shearin, PT, PhD","CONTACT","214-648-6564","staci.shearin@utsw.edu",{"lat":83,"lon":84},32.78306,-96.80667,[86],{"name":78,"role":79,"phone":80,"email":87},"staci.shearin@utsouthwestern.edu",[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Cerebellar ataxia",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"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, meaning participants will receive a specific treatment. It is a randomized controlled trial and plans to enroll 20 participants.","completed","Foot Orthoses for Ataxia Gait Study","This study is looking at how wearing foot orthoses (special shoe inserts) might help people with ataxia (a condition that affects coordination and balance) walk better. Researchers want to see if these orthoses can improve your gait (the way you walk) and balance. You might be able to join if you have cerebellar ataxia, are 18 or older, and can walk 16 feet with or without help. The study will measure your walking ability at the start and again after 14 days of wearing the orthoses. The current recruitment status is unclear, and the study plans to enroll 20 participants.","Your walking will be measured at day one (baseline) and again 14 days after you start wearing the orthosis.",100,"Participants will wear the orthoses at home and record the time they wear them. Your walking will be measured on a Zeno Walkway at the start and after 14 days.","Not stated in the trial record.",[],"v2"]