Clinical trial NCT06832384: Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors
Official title: Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Posterior Fossa Tumor
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, teen agers and young adults affected by posterior fossa tumors will be collected in three different centers, nemely IRCCS Medea located in Bosisio Parini, Conegliano and Brindisi.

Brief summary: 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)

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

Primary outcomes:
measure: Gross Motor Function Measure (GMFM)
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
Secondary outcomes:
measure: Six minutes walking test (6MWT)
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
measure: Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
measure: Pediatric Balance Scale (PBS)
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
measure: WeeFIM
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
measure: gait analysis
timeFrame: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
city: Conegliano
country: Italy
facility: IRCCS E. Medea
state: Treviso
city: Brindisi
country: Italy
facility: IRCCS E. Medea
Study officials:
References: