{
    "info": {
        "nct_id": "NCT03945682",
        "official_title": "The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour (ASPECT)",
        "inclusion_criteria": "* Child or young person (4-<18 years) demonstrating ataxia. (For this study, ataxia is currently defined as SARA greater than 2. This definition is taken from data from the CARS study to date, from the cut off threshold value distinguishing no ataxia from mild ataxia)\n* 12 months to 3 years following surgical resection of posterior fossa tumour. (This time frame has been selected as this covers the time when the children will typically have completed any adjunct oncology treatment and therefore more emphasis is dedicated to rehabilitation).\nHealthy volunteers allowed\nMust have minimum age of 4 Years\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Medically unstable/currently undergoing adjunctive treatment e.g. radiotherapy or chemotherapy\n* Less than 4 years of age (due to inability to complete standardized assessments)\n* Aged 18 or over\n* Unable to stand independently for less than one minute or SARA gait item score over 4, either of which would inhibit capacity to complete the training session.\n* Presence of co-morbities with the potential to affect the safety of training, such as congenital or acquired disorders causing high risk of falls or lack of comprehension of training tasks, or current musculoskeletal impairments (such as a non-union fracture or fracture currently healing limiting weight-bearing)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Child or young person (4-<18 years) demonstrating ataxia. (For this study, ataxia is currently defined as SARA greater than 2. This definition is taken from data from the CARS study to date, from the cut off threshold value distinguishing no ataxia from mild ataxia)",
            "criterions": [
                {
                    "exact_snippets": "Child or young person (4-<18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrating ataxia",
                    "criterion": "ataxia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "SARA greater than 2",
                    "criterion": "SARA score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 12 months to 3 years following surgical resection of posterior fossa tumour. (This time frame has been selected as this covers the time when the children will typically have completed any adjunct oncology treatment and therefore more emphasis is dedicated to rehabilitation).",
            "criterions": [
                {
                    "exact_snippets": "12 months to 3 years following surgical resection of posterior fossa tumour",
                    "criterion": "time since surgical resection of posterior fossa tumour",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 4 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 4 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Medically unstable/currently undergoing adjunctive treatment e.g. radiotherapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Medically unstable",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "currently undergoing adjunctive treatment",
                    "criterion": "adjunctive treatment",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "e.g. radiotherapy or chemotherapy",
                    "criterion": "types of adjunctive treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment types",
                            "expected_value": [
                                "radiotherapy",
                                "chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 4 years of age (due to inability to complete standardized assessments)",
            "criterions": [
                {
                    "exact_snippets": "Less than 4 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged 18 or over",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 or over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to stand independently for less than one minute or SARA gait item score over 4, either of which would inhibit capacity to complete the training session.",
            "criterions": [
                {
                    "exact_snippets": "Unable to stand independently for less than one minute",
                    "criterion": "ability to stand independently",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "minute"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SARA gait item score over 4",
                    "criterion": "SARA gait item score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of co-morbities with the potential to affect the safety of training, such as congenital or acquired disorders causing high risk of falls or lack of comprehension of training tasks, or current musculoskeletal impairments (such as a non-union fracture or fracture currently healing limiting weight-bearing)",
            "criterions": [
                {
                    "exact_snippets": "Presence of co-morbities with the potential to affect the safety of training",
                    "criterion": "co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital or acquired disorders causing high risk of falls",
                    "criterion": "disorders causing high risk of falls",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of comprehension of training tasks",
                    "criterion": "comprehension of training tasks",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "current musculoskeletal impairments (such as a non-union fracture or fracture currently healing limiting weight-bearing)",
                    "criterion": "musculoskeletal impairments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}