Clinical trial NCT04528316: Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
Official title: Impact of Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Fossa Tumor
Medulloblastoma, Childhood
Keywords: physical activity
postural stability
coordination
posterior fossa tumor
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. To investigate the effectiveness of Pilates core stability exercises program. 2. To investigate the effectiveness of Humac balance and tilt system.

Secondary Objectives:

1. The effectiveness of coordination training in children with posterior fossa tumors.
2. The comparison between balance and coordination training and which of both trainings has more effect.

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.

Eligibility criteria: Inclusion Criteria:

1. Children with posterior fossa tumors during follow up.
2. Children between 5-12 years old.
3. Time elapsed since the start of treatment more than 4 months in order to be in maintenance phase.
4. They can understand verbal command.
5. Children with no visual, auditory or perceptual disorders.
6. Children are already treated surgically.

Exclusion Criteria:

* Children who have one or more of the following criteria will be excluded from the study:

  1. Children with a genetic disorder or mental retardation.
  2. Children with a chronic lung disease.
  3. Sever cardiomyopathy (ejection fraction \<40%, ischemia and angina pectoris at rest).
  4. Children with a neuromuscular disease not related to tumor.

Primary outcomes:
measure: Change Balance
timeFrame: at week 12
Secondary outcomes:
measure: Change Coordination
timeFrame: at week 12
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
Study officials:
affiliation: Cairo University
name: Mahmoud Usama Mahmoud Ahmed, MSc
role: PRINCIPAL_INVESTIGATOR
References: