Posterior Fossa TumorNCT06832384
Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors
An observational study of Posterior Fossa Tumor, run by IRCCS Eugenio Medea at 3 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Posterior Fossa Tumor
- What is being tested?
- intensive physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 3 sitesItaly
- Study dates
- 19 Jan 2023to 19 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years
Who cannot join
- Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Daniele Panzeri, Physiotherapy degree, +39 031 877878, daniele.panzeri@lanostrafamiglia.it
- Recruiting
IRCCS E. Medea
Brindisi, Brindisi, 72100
Claudia Zigrino, Physiotherapy degree, 0831 349431, claudia.zigrino@lanostrafamiglia.it
- Recruiting
IRCCS E. Medea
Conegliano, Treviso, 31015
Silvia Spolverato, neuropsychiatry degree, 0438410257, silvia.spolverato@lanostrafamiglia.it
About this study
Official title: Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
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
Read the 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)
- Conditions
- Posterior Fossa Tumor
- Being tested
- intensive physiotherapy
- Medical subject headings
- Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive physiotherapyProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| study group | Not described Receives: Procedure: intensive physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The test is used to evaluate the walking endurance. During the test the distance covered over six minute of self-paced walking along a standardized path is measured, providing a reliable measure of patient's limitations as community ambulators.
Measured: 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)
This scale is developed to quantify the severity of the ataxia. It includes motor tasks (that investigate the most common deficits, like imbalance, tremors, dysmetria, rhythmic movements) and one item that examine the speech. This validated tool scores from 0 (no ataxia) to 40 (severe ataxia) and is composed by 8 items that comprise assessment of speech, upper and lower limb ability
Measured: 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)
The scale is used to assess balance skills in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
WeeFIM
This assessment measures the type and amount of assistance required for a person with a disability to perform basic life activities effectively.
It is an 18-item performance measurement system that documents self-care, functional mobility, and cognitive abilities. The self-care domain includes 8 items (eating, grooming, bathing, lower and upper body dressing, toileting, as well as bowel and bladder control). The mobility domain includes 5 items (chair, toilet, and tub transfers, walking or wheelchair management, and stairs). The cognitive domain includes 5 items (language comprehension and expression, social interaction, problem solving, and memory).
Measured: 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
3D gait analysis is an assessment performed with an eight cameras optoelectronic system working at 100 Hz and two force plates. During the analysis participants are asked to walk at their preferred speed and barefoot. For each assessment, at least five trials for the left and the right limbs were collected and processed using dedicated software. The most representative trial for each child is selected for further analysis.
Measured: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start19 Jan 2023
- Primary completion19 Jan 2026 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Fossa TumorStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832384
- Sponsor's protocol ID
- 21.2022 Oss
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
- ClinicalTrials.gov ID
- NCT06832384
- Acronym / sponsor ID
- 21.2022 Oss
- Conditions
- Posterior Fossa Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 19 Jan 2026 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: intensive physiotherapy |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years
Key exclusion criteria (1 listed)
- Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive physiotherapythe 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. | Procedure or surgery | study group |
Primary outcome
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
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Posterior Fossa Tumor
RecruitingPhase 2
Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma
Posterior Fossa Ependymal Tumor
RecruitingPhase 3
Dexmedetomidine Use for Greater Occipital Nerve Block in Pediatric Posterior Fossa Tumor Surgery.
Posterior Fossa Tumor
RecruitingObservational study
Physical Performance and Quality of Life in Children With Brain Tumors
Posterior Fossa Brain Tumor Group, Healthy Control Group
Not yet recruitingPhase 1/2
A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma
High-Grade Glioma (HGG), Posterior Fossa-A Ependymoma
Not yet recruitingObservational study
Pediatric Midline Post Fossa Tumors Prognostic Factors and Outcomes
Pediatric Tumor, Midline Posterior Fossa Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Fossa Tumor, run by IRCCS Eugenio Medea at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.