Efficacy of hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) in young children with bilateral cerebral palsy (GMFCS III-IV) in a low and middle-income country: protocol of a randomised controlled trial
Bibliographic record
Abstract
INTRODUCTION: Cerebral palsy (CP) is highly prevalent in sub-Saharan Africa, where clinically-based studies have shown a considerable over-representation of the severe bilateral subtype. However, children's access to rehabilitation care is limited by many local factors, notably the lacking of rehabilitation services, insufficient knowledge of caregivers and financial constraints. In such a context there is an urgent need for studies of the evidence-based rehabilitation approach. Here, we describe the protocol of a randomised controlled study to investigate the efficacy of Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE) in young children with bilateral CP in Benin Republic, a representative low and middle-income country of western Africa. METHODS AND ANALYSIS: Forty children with bilateral CP aged between 24 and 59 months and with level III-IV in the gross motor function classification will be randomised to either a high intensity conventional therapy or HABIT-ILE therapy. Both therapies will be delivered as a day-camp model over 2 weeks to a total of 50 hours (5 hours per day). The assessor-blinded primary outcomes will include the gross motor function measure and both hands assessment. Secondary outcomes will be the adapted version of the ACTIVLIM-CP questionnaire, the Canadian Occupational Performance Measure, and a perception of CP interview form. Children will be assessed at baseline, after intervention and at 6-week follow-up. A 2 (group)×3 (test sessions) repeated analysis of variance will evaluate changes after the interventions. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the rehabilitation department of the National Teaching Hospital Hubert Koutoukou Maga of Cotonou, Benin (approval decision: N°01-2019/MS/CNHU-HKM/CEI/CUMPR). All participants' parents/caregivers will provide their written informed consent. Data will be managed with confidentiality. TRIAL REGISTRATION NUMBER: PACTR201911894444879.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.023 | 0.021 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.005 |
| Insufficient payload (model declined to judge) | 0.034 | 0.005 |
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 source (direct Gemma or distilled Codex), 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".