Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intensive physiotherapy.
- Who it may be relevant to
- Registry conditions: Posterior Fossa Tumor. Basic parameters: 0 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
Overview
The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors
Detailed description
The surgery aimed to remove tumors located in the cranial posterior fossa can lead, as a consequence, to a clinical condition of ataxia.
Children affected by this condition are commonly referred to physiotherapy treatment, even though the level of scientific evidence in the field of motor rehabilitation is still lacking.
The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors.
By conventional physiotherapy intervention we mean a therapeutic path with a 1:1 operator-patient ratio and which does not make use of robotic or virtual reality devices.
By intensive we mean that it occurs twice a day, 5 days a week, for a duration of four weeks.
Given the high variability in the severity of the clinical pictures, the primary objective will be the patient's improvement in gross motor skills as a whole, which will be identified with the Gross Motor Function Measurment (GMFM) scale.
Changes will also be monitored with respect to the autonomy and assistive care in the daily life of the recruited patients (scored through WeeFIM or FIM), the risk of fall (scored through the Pediatric Balance Scale) and with a sign-specific scale on ataxia (Scale for Assessment and Rating of Ataxia) Finally, for walking patients, walking resistance will be assessed through the 6 minute walking test (6MWT)
Interventions
- Procedure intensive physiotherapy
the dosing of the intensive physiotherapy is of 2 sessions a day, lasting 45 minutes each, administered 5 days a week, for a period of 4 weeks. the physiotherapy is mainly addressed to the improvement of gross motor movement and balance and the training is designed according to the specific need of the subject recruited. it is not allowed the use of technological devices, excepted treadmill training.
Primary outcome measures
- Gross Motor Function Measure (GMFM) [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
Secondary outcome measures (5)
- Six minutes walking test (6MWT) [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- Pediatric Balance Scale (PBS) [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- WeeFIM [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- gait analysis [Time frame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
Eligibility criteria
Inclusion criteria
- subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years
Exclusion criteria
- Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- IRCCS E. Medea — Brindisi
- IRCCS E. Medea — Bosisio Parini
- IRCCS E. Medea — Conegliano
Identifiers
NCT: NCT06832384 · 21.2022 Oss