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Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. It has been reported that those children fall frequently so the purpose of this study is to investigate the effectiveness of balance and coordination training in these Children.
The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited.
There are Two Main objectives:
Secondary Objectives:
This study will take place in a pediatric oncology setting, Children's Cancer Hospital Egypt(CCHE), in outpatient setting. Patients will be evaluated for their balance and coordination at initial presentation, during treatment, and during follow-up after end of treatment at CCHE. Also patients will receive balance and coordination training, before each chemotherapy cycle-maximum one week- given the patient is in good state.
Sixty children with posterior fossa tumors of both sexes will participate in this study. They will be selected from CCHE. They will be randomly assigned into 3 groups of equal number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group/Pilates Core Stability Exercises program Group | Active Comparator | Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks Stages: Three stages:
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| Balance Group | Experimental | Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program |
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| Coordination Group | Experimental | Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilates Core Stability Exercises program | Behavioral | Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks Stages: Three stages:
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| Measure | Description | Time Frame |
|---|---|---|
| Change Balance | For assessment of the three groups, HUMAC balance and tilt system will be used to assess both Static and dynamic balance. | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change Coordination | The Bruininks-Oseretsky Test of Motor Proficiency - Second Edition - The minimum and maximum values: Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too. The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores. Bilateral Coordination: Total Point Score Subtest (min=Zero, max=24). Upper-Limb Coordination: Total Point Score Subtest (min=Zero, max=39). - Higher scores mean a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
Children who have one or more of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Usama Mahmoud Ahmed, MSc | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Cancer Hospital Egypt 57357 | Cairo | 11441 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525069 | Derived | Usama M, Abdelaziem F, Rashed WM, Maher E, El Beltagy M, Zekri W. Impact of physical activity on postural stability and coordination in children with posterior fossa tumor: randomized control phase III trial. J Cancer Res Clin Oncol. 2023 Aug;149(9):5637-5644. doi: 10.1007/s00432-022-04490-4. Epub 2022 Dec 16. |
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| ID | Term |
|---|---|
| D015192 | Infratentorial Neoplasms |
| D008527 | Medulloblastoma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
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| Balance Program | Behavioral | Total Period: 12 Weeks. The designed HUMAC program will work on the modified clinical test of sensory integration of balance (mCTSIB) with eyes open and with eyes closed, the center of pressure (COP) and the limit of stability test (LOS). |
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| Coordination | Behavioral | Total Period: 12 Weeks. Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too. The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores. |
|
| at week 12 |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001519 | Behavior |