Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors
ConditionPosterior Fossa Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-25
SponsorIRCCS Eugenio Medea
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years
Disqualifiers
Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
intensive physiotherapy
Procedure/Surgerythe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: study group1 intervention
Trial outcomes
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).
Time frame
A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeksSecondary outcomes
1
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.
Time frame
A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks2
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
Time frame
A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks3
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.
Time frame
A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks4
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).
Time frame
A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeksSponsors and contacts
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Source ClinicalTrials.gov