{"doi":"10.1136/bmjopen-2023-073166","title":"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","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.","journal":"BMJ Open","year":2023,"id":362688,"datarank":0.36021375376148884,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.030630067161055857,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.030630067161055857,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":3,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9515,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04897347"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":950333,"name":"Xupeng Ai","orcid":"0000-0003-4155-9348","position":1,"is_corresponding":false},{"id":691737,"name":"Karen Chin","orcid":null,"position":2,"is_corresponding":false},{"id":1116718,"name":"Joseph P. Dutkowsky","orcid":null,"position":3,"is_corresponding":false},{"id":443818,"name":"Andrew M. Gordon","orcid":"0000-0003-1041-0479","position":4,"is_corresponding":false},{"id":383681,"name":"Sunil K. Agrawal","orcid":"0000-0002-4008-1437","position":5,"is_corresponding":false},{"id":950334,"name":"Victor Santamaria","orcid":"0000-0002-7889-6957","position":0,"is_corresponding":true}],"reference_count":67,"raw_metadata":null,"created_at":"2026-07-19T01:14:23.749325Z","pmid":"37591642","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}