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Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor

C

Children's Cancer Hospital Egypt 57357

Status

Completed

Conditions

Medulloblastoma, Childhood
Posterior Fossa Tumor

Treatments

Behavioral: Pilates Core Stability Exercises program
Behavioral: Balance Program
Behavioral: Coordination

Study type

Interventional

Funder types

Other

Identifiers

NCT04528316
CCHE-BT003

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Control Group/Pilates Core Stability Exercises program Group
Active Comparator group
Description:
Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks Stages: Three stages: * Stage I: Warm-up: consists of four Pilates motions: 1. Breathing: 2. Rolling back: 3. Coccyx-curl: 4. Hundred breathing: * Stage II: Work-out: consists of twelve Pilates motions: 1. Single leg stretch: 2. Straight leg raise: 3. Basic bridge: 4. Bridging variation: 5. Quadruped: 6. Clap with seal motion 7. Mermaid twist: 8. Swimming: 9. Double leg stretch: 10. Shoulder bridge: 11. Swan dive: 12. Leg full front: * Stage III: Cool-down: consists of three Pilates motions: 1. Rest position: 2. Cat with arm/leg extension: 3. Breathing:
Treatment:
Behavioral: Pilates Core Stability Exercises program
Balance Group
Experimental group
Description:
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program
Treatment:
Behavioral: Pilates Core Stability Exercises program
Behavioral: Balance Program
Coordination Group
Experimental group
Description:
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises.
Treatment:
Behavioral: Pilates Core Stability Exercises program
Behavioral: Coordination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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