[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654253":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":35,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":66,"collaborators":18,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":95,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Groupe Hospitalier Nord-Essonne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Performance on the Individualized Functional Motor Skill","Motor performance will be assessed using one predefined, task-specific, directly observable quantitative indicator for each individualized functional motor skill. Depending on the selected skill, the indicator may be the number or proportion of successful trials, completion time, accuracy, or another objective task-specific measure. The indicator and the direction indicating improvement will be defined before baseline and will remain unchanged throughout baseline, intervention, and follow-up. Each skill and participant will be analyzed separately in the original unit of measurement; data from different task-specific indicators will not be aggregated.","Once weekly during the 6- to 9-week baseline phase, at each of the 10 intervention sessions, and once weekly during the 5-week post-intervention follow-up phase.",[14],{"measure":15,"description":16,"timeFrame":17},"Goal Attainment Scaling Attainment Level","Attainment of the individualized functional motor goal will be assessed using Goal Attainment Scaling (GAS). Goal achievement is rated on a five-point ordinal scale ranging from -2 to +2, where -2 indicates a level much lower than the expected outcome, -1 a level lower than expected, 0 the expected level of attainment, +1 a level higher than expected, and +2 a level much higher than expected. Higher scores indicate greater goal attainment.","At baseline goal setting, after completion of the 10-session intervention, and at the end of the 5-week follow-up phase.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"NA","SINGLE_GROUP","Single-case experimental design using a concurrent multiple-baseline design replicated across three successive cohorts of four participants. Within each cohort, introduction of Neuromotor Task Training will be staggered across participants, with baseline phases lasting approximately 6, 7, 8, and 9 weeks. All participants will receive the intervention targeting an individualized functional motor skill. Each participant will serve as their own control through repeated measurements collected during baseline, intervention, and follow-up phases.","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":18},"NONE","This is an open-label, single-arm study. When feasible, video-recorded motor performances will be rated by an external outcomes assessor who is not involved in the intervention sessions and is masked to the study phase and timing of the assessment.","Autism spectrum disorder is frequently associated with motor difficulties that may affect autonomy, participation in daily activities, and quality of life. These difficulties may involve balance, coordination, motor planning, object manipulation, fine motor skills, gross motor skills, or the learning of functional motor skills. This study evaluates the use of Neuromotor Task Training (NTT), a task-oriented rehabilitation approach, in autistic children with motor difficulties.\n\nThe study will include 12 autistic children aged 6 to 10 years who present motor difficulties. Participants will be recruited in the context of their usual clinical care pathway, including child and adolescent mental health or medico-psychological services. Inclusion will require a diagnosis of autism spectrum disorder, an intelligence quotient of 70 or above, and motor difficulties documented through clinical assessment and standardized motor assessment. Standardized assessments may include the Movement Assessment Battery for Children, Third Edition (MABC-3), and the Developmental Coordination Disorder Questionnaire (DCD-Q), in order to document the presence and severity of motor difficulties in daily life.\n\nThe study uses a concurrent multiple-baseline single-case experimental design replicated across three successive cohorts of four participants. This design is well suited to the evaluation of individualized rehabilitation approaches in small clinical samples. Each participant serves as their own control through repeated measurements across successive study phases. Within each cohort, the introduction of the intervention will be staggered across participants to provide multiple opportunities to demonstrate an intervention effect at different points in time. Replication of the experimental procedure across three independent cohorts is intended to strengthen the internal validity of the study.\n\nThe study procedure includes four main stages: inclusion and initial assessment, pre-intervention baseline, intervention, and post-intervention follow-up.\n\nDuring the inclusion and initial assessment stage, eligibility criteria will be checked. Motor difficulties will be documented using standardized motor tools and clinical assessment. The child's ability to understand and participate in the motor training sessions will also be considered. Written informed consent will be obtained from the child's legal representative(s), and the child's assent will be sought whenever possible according to age and level of understanding.\n\nThe pre-intervention baseline phase will last approximately 6 to 9 weeks. During this phase, the child, family, and researcher or therapist will identify one meaningful functional motor skill that is difficult for the child in daily life. Examples may include catching a ball, jumping rope, putting on a coat, cutting with scissors, or another functional task relevant to the child's autonomy and participation. The selected target skill will be defined in measurable terms so that repeated performance assessments can be conducted throughout the study.\n\nDuring the baseline phase, the primary outcome will be assessed once weekly. In accordance with the What Works Clearinghouse single-case design standards (Version 5.0), each participant will complete a minimum of six baseline assessments. Within each cohort, introduction of the intervention will be staggered across participants, resulting in baseline phases of approximately 6, 7, 8, and 9 weeks, respectively. Baseline measurements will continue for participants who have not yet entered the intervention phase. Individualized goals will also be formalized using Goal Attainment Scaling (GAS), and a sensory profile assessment will be administered to identify sensory preferences, sensitivities, or aversions that may influence the child's engagement, learning conditions, response to feedback, or tolerance of the practice environment.\n\nThe intervention phase will consist of 10 Neuromotor Task Training sessions. NTT is a task-oriented rehabilitation approach based on the direct practice of meaningful motor tasks. The intervention focuses on a functional motor skill selected according to the child's needs, family priorities, and clinical assessment. The therapist analyzes the task requirements, including spatial, temporal, sequential, coordinative, and environmental demands. The therapist also analyzes the child's performance in order to identify factors that may limit successful task execution.\n\nDuring the NTT sessions, task constraints, environmental conditions, and individual support will be adjusted progressively. These adaptations may include changes in distance, speed, object size, spatial organization, task complexity, attentional demands, or environmental constraints. Instructions, demonstrations, practice structure, and feedback will be adapted according to the child's stage of motor learning and sensory profile. Feedback may focus on the result of the action, the quality of movement, or environmental cues that help the child adjust their performance. The aim is to support the emergence, stabilization, and generalization of more efficient motor coordination.\n\nRepeated motor performance measurements will be collected during each intervention session. The performance metric will be selected according to the target skill and will be objective, functional, and sensitive to change. Examples may include the number of successful trials, time needed to complete the task, accuracy, or another task-specific quantitative indicator. These repeated measurements will make it possible to describe each participant's learning trajectory over time.\n\nTo limit assessment bias, motor performance measures may be video-recorded and rated secondarily by an external outcome assessor who is not involved in the training sessions. When feasible, the assessor will be masked to the study phase. This procedure is intended to improve the reliability of outcome assessment while taking into account the practical constraints of a rehabilitation study conducted in a clinical setting.\n\nAfter the 10-session intervention phase, a post-intervention follow-up phase will be conducted for approximately 3 to 5 weeks. During this phase, repeated performance measurements will continue without active NTT training on the target skill. This phase will allow the researchers to examine whether the acquired motor performance is maintained after the intervention. The follow-up phase will also help document retention and possible generalization of the motor skill to daily-life contexts, such as home, school, or other relevant environments.\n\nGoal Attainment Scaling will be rated after completion of the 10-session intervention and again at the end of the 5-week follow-up phase to quantify the extent to which the individualized functional goal has been achieved and maintained. The MABC-3 will be used at baseline to characterize participants' motor difficulties and will not constitute a pre-specified intervention outcome.\n\nThe primary focus of the study is the change in performance on the individualized functional motor skill across baseline, intervention, and follow-up phases. Visual analysis of repeated performance data will be used to examine level, trend, slope, stability, immediacy of effect, overlap between phases, and maintenance of gains. Statistical analyses adapted to single-case experimental designs may also be used, including non-overlap indices such as Tau-U or modified Tau-U, in order to quantify the magnitude of change between phases.\n\nSecondary and exploratory analyses may examine individual learning profiles, variability of response to NTT, maintenance of gains, and the possible contribution of sensory profile characteristics to intervention adaptation. When appropriate, exploratory analyses may also use dimensional reduction or clustering approaches to describe patterns of response across participants. These analyses will remain exploratory and will be interpreted with caution because of the small sample size and individualized nature of the intervention.\n\nThis study is designed to provide clinically relevant information about the implementation of task-oriented motor rehabilitation in autistic children with motor difficulties. It aims to document whether NTT may help improve meaningful functional motor skills, how performance changes over time, and under which clinical conditions this approach may be adapted to the needs of autistic children.",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"Neuromotor Task Training","EXPERIMENTAL","Participants will be enrolled in three successive cohorts of four children. All participants will receive Neuromotor Task Training focused on an individualized functional motor skill. The cohort structure is used to support replication within the single-case experimental design. It does not correspond to different intervention groups.",[34],"Behavioral: Neuromotor Task Training",[36],{"type":37,"name":30,"description":38,"armGroupLabels":39,"otherNames":18},"BEHAVIORAL","Neuromotor Task Training is a task-oriented rehabilitation approach focused on the practice of meaningful functional motor skills. The therapist analyzes the selected task and adapts task constraints, environmental conditions, practice organization, and feedback to support motor learning. In this study, each participant will receive Neuromotor Task Training sessions targeting an individualized motor skill selected before the intervention phase.",[30],[41],{"name":42,"affiliation":5,"role":43},"Aurélien D'Ignazio, MSc","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":18,"email":49},"Aurélien D'Ignazio, MSc (PhD studend)","CONTACT","+33 6 89 56 66 43","aurelien.d-ignazio@polesante.eu",[51],{"facility":5,"status":18,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Bures-sur-Yvette","Essone","91440","France","FR",{"type":58,"coordinates":59},"Point",[60,61],2.17064,48.69981,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":48,"phoneExt":18,"email":49},"Aurélien D'Ignazio, MSc, PhD student",{"type":67,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100654253","neuromotor-task-training-in-autistic-children-with-motor-difficulties-100654253",false,"NCT07797439","Neuromotor Task Training in Autistic Children With Motor Difficulties","Evaluation of the Effectiveness of the Neuromotor Task Training Approach in the Rehabilitation of Motor Difficulties in Children With Autism Spectrum Disorder: A Single-Case Experimental Design Study","NTT-SCED","Inclusion Criteria:\n\n* Children aged 6 to 10 years.\n\n  * Diagnosis of autism spectrum disorder.\n  * Presence of motor difficulties documented by clinical assessment and\u002For standardized motor assessment.\n  * Ability to understand and participate in the proposed motor training sessions.\n  * Written informed consent from the child's legal representative(s).\n  * Child assent whenever possible, according to age and level of understanding.\n  * Participation in the usual care pathway at the investigating center.\n\nExclusion Criteria:\n\n* Intelligence quotient below 70, when documented, or severe cognitive impairment preventing understanding of the tasks or participation in the training sessions.\n* Medical, neurological, orthopedic, or sensory condition that would contraindicate participation in motor training.\n* Uncontrolled epilepsy or any unstable medical condition that could interfere with participation.\n* Severe behavioral difficulties making repeated assessment or motor training impossible.\n* Ongoing participation in another interventional study that could interfere with the outcomes of this study.","ALL","6 Years","10 Years",{"count":80,"type":81},12,"ESTIMATED","INTERVENTIONAL",[20],"The goal of this clinical study is to learn whether Neuromotor Task Training (NTT) may help improve functional motor skills in autistic children who have motor difficulties.\n\nThe main question it aims to answer is:\n\nDoes Neuromotor Task Training help autistic children improve a motor skill that is difficult for them in daily life?\n\nThis study will include autistic children with motor difficulties. Each child will work on one functional motor skill chosen according to their needs and daily-life goals. Examples may include skills such as catching a ball, jumping rope, putting on a coat, or another meaningful motor task.\n\nParticipants will take part in an initial assessment of their motor abilities. They will then choose, with their family and the researcher, a functional motor skill to work on. The selected skill will be assessed repeatedly before, during, and after the training period. Participants will receive Neuromotor Task Training sessions focused on this skill. They will also be followed after the training period to see whether the motor skill is maintained.\n\nNeuromotor Task Training is a task-oriented rehabilitation approach. It focuses on practicing meaningful motor skills in conditions that are progressively adapted to the child. The task, the environment, and the feedback provided by the therapist may be adjusted during the sessions to support motor learning.\n\nThis study uses a single-case experimental design. This means that each participant's progress is measured repeatedly over time. The researchers will examine whether motor performance changes after the start of the training and whether these changes are maintained after the training period.",[86],"Autism Spectrum Disorder (ASD)",[88,89,90,91,92,30,93,94],"Developmental Coordination Disorder","Motor Skills","Motor Difficulties","Motor Learning","Motor Rehabilitation","Single-Case Experimental Design","Task-Oriented Training","NOT_YET_RECRUITING","2026-09-22",{"date":98,"type":99},"2026-09-25","ACTUAL",{"date":101,"type":81},"2026-10",{"date":103,"type":81},"2027-12",{"name":5,"class":6},1]