Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors

NCT06832384 | Recruiting

• 1 other identifier: 21.2022 Oss
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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

Conditions

Posterior Fossa Tumor

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure (GMFM)

  The GMFM is composed by 88 items (providing a range of score form 0 to 3 each) divided in 5 sections: A- lying and rolling; B- sitting; (C) crawling and kneeling; D - standing; E - walking, running and jumping. The total score can range between 0 (subject can't perform any gross motor activity) to a maximum of 264 (the subject completely developed his gross motor skills).

  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 (5)

• Six minutes walking test (6MWT)

  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)

  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)

  A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks

• WeeFIM

  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

  A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks

Study Arms (1)

study group

Procedure: intensive physiotherapy

Interventions

intensive physiotherapy 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.

study group

Eligibility Criteria

• Age: 0 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years

You may not qualify if:

• Subjects that are currently addressed to rehabilitative protocols availing of technological devices

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (3)

IRCCS E. Medea

Brindisi, Brindisi, 72100, Italy

RECRUITING

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

IRCCS E. Medea

Conegliano, Treviso, 31015, Italy

RECRUITING

MeSH Terms

Conditions

Infratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: January 19, 2023
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

IT (3)