Study Protocol for a Randomised Controlled Trial to Determine the Efficacy of an Intensive Seated Postural Intervention Delivered With Robotic and Rigid Trunk Support Systems
Bibliographic record
Abstract
INTRODUCTION: Children with cerebral palsy (CP) classified as gross motor function classification system (GMFCS) levels III-IV demonstrate impaired sitting and reaching control abilities that hamper their overall functional performance. Yet, efficacious interventions for improving sitting-related activities are scarce. We recently designed a motor learning-based intervention delivered with a robotic Trunk-Support-Trainer (TruST-intervention), in which we apply force field technology to individualise sitting balance support. We propose a randomised controlled trial to test the efficacy of the motor intervention delivered with robotic TruST compared with a static trunk support system. METHODS AND ANALYSIS: We will recruit 82 participants with CP, GMFCS III-IV, and aged 6-17 years. Randomisation using concealed allocation to either the TruST-support or static trunk-support intervention will be conducted using opaque-sealed envelopes prepared by someone unrelated to the study. We will apply an intention-to-treat protocol. The interventions will consist of 2 hours/sessions, 3/week, for 4 weeks. Participants will start both interventions with pelvic strapping. In the TruST-intervention, postural task progression will be implemented by a progressive increase of the force field boundaries and then by removing the pelvic straps. In the static trunk support-intervention, we will progressively lower the trunk support and remove pelvic strapping. Outcomes will be assessed at baseline, training midpoint, 1-week postintervention, and 3-month follow-up. Primary outcomes will include the modified functional reach test, a kinematic evaluation of sitting workspace, and the Box and Block test. Secondary outcomes will include The Segmental Assessment of Trunk Control test, Seated Postural & Reaching Control test, Gross Motor Function Measure-Item Set, Canadian Occupational Performance Outcome, The Participation and Environment Measure and Youth, and postural and reaching kinematics. ETHICS AND DISSEMINATION: The study was approved by the Columbia University Institutional Review Board (AAAS7804). This study is funded by the National Institutes of Health (1R01HD101903-01) and is registered at clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT04897347; clinicaltrials.gov.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".