- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07797439
Neuromotor Task Training in Autistic Children With Motor Difficulties (NTT-SCED)
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
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.
The main question it aims to answer is:
Does Neuromotor Task Training help autistic children improve a motor skill that is difficult for them in daily life?
This 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.
Participants 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.
Neuromotor 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.
This 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
The study uses a single-case experimental design with repeated measures and multiple baseline logic. 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. Participants will be enrolled in three successive cohorts of four children. This cohort structure is intended to support replication of the experimental procedure across independent series of participants and to strengthen the internal validity of the single-case design.
The study procedure includes four main stages: inclusion and initial assessment, pre-intervention baseline, intervention, and post-intervention follow-up.
During 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.
The pre-intervention phase will last approximately 3 to 5 weeks. During this phase, the child, family, and researcher or therapist will identify one or more meaningful functional motor skills that are 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.
During the pre-intervention phase, individualized goals will also be formalized using Goal Attainment Scaling (GAS). 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. Initial repeated measurements of the selected motor skill will be collected during this phase to establish the baseline level of performance before the introduction of NTT.
The 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.
During 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.
Repeated 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.
To 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.
After 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.
At the end of the intervention and follow-up period, Goal Attainment Scaling will be rated again to quantify the extent to which the individualized goals have been achieved. The MABC-3 may also be readministered after the intervention period to document changes in standardized motor performance. These measures will complement the repeated task-specific performance measures and help interpret each child's clinical trajectory.
The 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.
Secondary 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.
This 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aurélien D'Ignazio, psychomotrician, PhD Stutend
- Phone Number: +33 6 89 56 66 43
- Email: aurelien.d-ignazio@polesante.eu
Study Locations
-
-
Essones
-
Bures-sur-Yvette, Essones, France, 91440
- Groupe Hospitalier Nord-Essonne
-
Contact:
- Aurélien D'Ignazio, PhD student
- Phone Number: +33 6 89 56 66 43
- Email: aurelien.d-ignazio@polesante.eu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children aged 6 to 10 years.
- Diagnosis of autism spectrum disorder.
- Presence of motor difficulties documented by clinical assessment and/or standardized motor assessment.
- Ability to understand and participate in the proposed motor training sessions.
- Written informed consent from the child's legal representative(s).
- Child assent whenever possible, according to age and level of understanding.
- Participation in the usual care pathway at the investigating center.
Exclusion Criteria:
- Intelligence quotient below 70, when documented, or severe cognitive impairment preventing understanding of the tasks or participation in the training sessions.
- Medical, neurological, orthopedic, or sensory condition that would contraindicate participation in motor training.
- Uncontrolled epilepsy or any unstable medical condition that could interfere with participation.
- Severe behavioral difficulties making repeated assessment or motor training impossible.
- Ongoing participation in another interventional study that could interfere with the outcomes of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neuromotor Task Training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Performance on the Individualized Functional Motor Skill
Time Frame: Weekly throughout baseline (5 to 8 assessments), the 10-week intervention period, and the 5-week follow-up period.
|
Motor performance will be assessed using one predefined, task-specific, directly observable quantitative indicator for each individualized motor skill.
The indicator will be selected before baseline and will remain unchanged throughout baseline, intervention, and follow-up.
Each individualized motor skill will be analyzed separately.
Performance data will be retained in their original unit of measurement, without conversion into a common standardized score.
Different task-specific indicators will not be aggregated across skills or participants.
|
Weekly throughout baseline (5 to 8 assessments), the 10-week intervention period, and the 5-week follow-up period.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHNE-NTT-TSA-SCED
- 2026-A00093-48 (Other Identifier: Comité de Protection des Personnes (French Ethics Committee))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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