NCT Number: NCT06832384
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
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Request Info0 year–25 year
All sexes
Observational
IRCCS E. Medea, Brindisi, Italy
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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 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 weeks
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 weeks
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 weeks
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 weeks
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.
IRCCS Eugenio Medea
Other
Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
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