Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Years - 25 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06832384
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS Eugenio Medea
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Posterior Fossa Tumor

Additional Details

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)

Arms & Interventions

Arms

: study group

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.

Contact a Trial Team

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International Sites

IRCCS E. Medea, Bosisio Parini, Lecco, Italy

Status

Recruiting

Address

IRCCS E. Medea

Bosisio Parini, Lecco, 23842

Site Contact

Daniele Panzeri, Physiotherapy degree

[email protected]

+39 031 877878

IRCCS E. Medea, Conegliano, Treviso, Italy

Status

Recruiting

Address

IRCCS E. Medea

Conegliano, Treviso, 31015

Site Contact

Silvia Spolverato, neuropsychiatry degree

[email protected]

0438410257

IRCCS E. Medea, Brindisi, Italy

Status

Recruiting

Address

IRCCS E. Medea

Brindisi, , 72100

Site Contact

Claudia Zigrino, Physiotherapy degree

[email protected]

0831 349431

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