Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors

NCT ID: NCT06832384

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-19

Study Completion Date

2026-01-19

Brief Summary

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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

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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)

Conditions

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Posterior Fossa Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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study group

intensive physiotherapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS E. Medea

Brindisi, Brindisi, Italy

Site Status RECRUITING

IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Site Status RECRUITING

IRCCS E. Medea

Conegliano, Treviso, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Claudia Zigrino, Physiotherapy degree

Role: primary

0831 349431

Daniele Panzeri, Physiotherapy degree

Role: primary

+39 031 877878

Silvia Spolverato, neuropsychiatry degree

Role: primary

0438410257

Other Identifiers

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21.2022 Oss

Identifier Type: -

Identifier Source: org_study_id

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