[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07184411":3,"trial-entities:NCT07184411":102,"trial-summary:NCT07184411":105},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":69,"locations":71,"central_contacts":93,"overall_officials":98,"references":100,"see_also_links":101},"NCT07184411","2245497","Activities-based Locomotor Training in Children With Cerebral Palsy","Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy.","RECRUITING","2028-08-31","2026-08","2026-08-24","2026-01-11","Baylor University","OTHER",true,"This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.",null,[19],"Cerebral Palsy (CP)",[21,22,23],"Cerebral Palsy","Locomotor Training","Physical Therapy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},19,"ESTIMATED",[32,37],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Activities-based locomotor training","Activities-based locomotor training involves placing the child in a partial body-weight supported (PBWS) system over a treadmill. The child is given assistance by trained clinicians to attempt standing and walking on the treadmill for 1 hour. The child then participates in play-based activities aimed to foster independence in an overground (regular) environment for 1 hour. The final hour of the 3-hour session is conducted in the PBWS system with a focus on standing and walking.",[36],"Activities-based locomotor training (AB-LT)",{"type":14,"name":38,"description":39,"armGroupLabels":40},"physical therapy","In this intervention, the child will attend their usual physical therapy sessions.",[41],"Usual care",[43],{"measure":44,"description":45,"timeFrame":46},"Gross Motor Function Measure (GMFM-66)","The GMFM-66 is the gold standard for measuring gross motor function in children with CP. A child's capabilities are scored across five dimensions (66 items), including Lying and Rolling (Dimension A), Sitting (Dimension B), Crawling and Kneeling (Dimension C), Standing (Dimension D), and Walking, Running, and Jumping (Dimension E).","4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.",[48,51],{"measure":49,"description":50,"timeFrame":46},"functional near infrared spectroscopy (fNIRS)","functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique that uses infrared light to assess hemodynamic shifts in the prefrontal cortex during movement. It involves wearing a lightweight neoprene headband that contains sensors.",{"measure":52,"description":53,"timeFrame":46},"Child Engagement in Daily Life (CEDL)","The Child Engagement in Daily Life (CEDL) is a survey completed by parents or caregivers of children, 18 months through 12 years of age. The CEDL describes a child's participation in daily activities such as interactions with others, play, and self-care.","ALL","2 Years","6 Years",false,{"inclusion":59,"exclusion":64,"raw_text":68},[60,61,62,63],"• Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);","Non-ambulatory or not walking as primary means of mobility;","Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours\u002F day, 5 days\u002Fweek, for 3 weeks; and","Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.",[65,66,67],"• Surgery or botulinum toxin injections in the previous 6 months;","Uncontrolled epilepsy; and","Uncontrolled cardiovascular disease","Inclusion Criteria: To be eligible for this study, the child must be:\n\n* • Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);\n\n  * Non-ambulatory or not walking as primary means of mobility;\n  * Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours\u002F day, 5 days\u002Fweek, for 3 weeks; and\n  * Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.\n\nExclusion Criteria: The child must not have:\n\n* • Surgery or botulinum toxin injections in the previous 6 months;\n\n  * Uncontrolled epilepsy; and\n  * Uncontrolled cardiovascular disease",[70],"CHILD",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":90},"Fortis Therapy Center","Dripping Springs","Texas","78620","United States",[79,84,88],{"name":80,"role":81,"phone":82,"email":83},"Elizabeth M Ardolino, PhD","CONTACT","215-605-9319","liz_ardolino@baylor.edu",{"name":85,"role":81,"phone":86,"email":87},"Megan Flores, PhD","512-529-4421","megan_flores@baylor.edu",{"name":80,"role":89},"PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},30.19021,-98.08668,[94,96],{"name":95,"role":81,"phone":82,"email":83},"Elizabeth Ardolino, PhD, PT",{"name":97,"role":81,"email":87},"Megan Flores, PhD, PT",[99],{"name":95,"affiliation":13,"role":89},[],[],{"nct_id":4,"conditions":103,"biomarkers":104},[21],[],{"nct_id":4,"found":15,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 19 children.","completed","Activities-based Locomotor Training for Children with Cerebral Palsy","This study is looking at a special type of physical therapy called Activities-based Locomotor Training (AB-LT) for children with Cerebral Palsy (CP). AB-LT involves helping children stand and walk on a treadmill while supported in a special harness. The study wants to see if AB-LT is more helpful than regular physical therapy in improving how children with CP move and their overall quality of life. They are looking for children aged 2 to 6 years old who have CP, can hold their head up for at least 5 seconds, and are not yet walking on their own. The study will measure improvements in motor function using a tool called the Gross Motor Function Measure (GMFM-66). The current status of this study is unclear, and it plans to enroll 19 participants.","Participants will be followed for up to 7 weeks, with measurements taken at specific points during this time.",130,"Participants will either receive Activities-based Locomotor Training (1 hour on a treadmill) or attend their usual physical therapy sessions. Measurements will be taken at baseline, end of week 3, end of week 4, and end of week 7.","Not stated in the trial record.",[33,38],"v2"]