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Completed

NCT Number: NCT04528316

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

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.

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Key information

Conditions

Posterior Fossa Tumor Behavior Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Infratentorial Neoplasms Medulloblastoma Medulloblastoma, Childhood Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

About this study

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:

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

Secondary Objectives:

  • The effectiveness of coordination training in children with posterior fossa tumors.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children who have one or more of the following criteria will be excluded from the study:
  • Children with a genetic disorder or mental retardation.
  • Children with a chronic lung disease.
  • Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
  • Children with a neuromuscular disease not related to tumor.

Treatment and study plan

Pilates Core Stability Exercises program

Behavioral

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:
  • Breathing:
  • Rolling back:
  • Coccyx-curl:
  • Hundred breathing:
  • Stage II: Work-out: consists of twelve Pilates motions:
  • Single leg stretch:
  • Straight leg raise:
  • Basic bridge:
  • Bridging variation:
  • Quadruped:
  • Clap with seal motion
  • Mermaid twist:
  • Swimming:
  • Double leg stretch:
  • Shoulder bridge:
  • Swan dive:
  • Leg full front:
  • Stage III: Cool-down: consists of three Pilates motions:
  • Rest position:
  • Cat with arm/leg extension:
  • Breathing:

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).

Other names: HUMAC program

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.

Primary outcomes

  1. Change Balance

    Time frame: at week 12

    For assessment of the three groups, HUMAC balance and tilt system will be used to assess both Static and dynamic balance.

Secondary outcomes

  1. Change Coordination

    Time frame: at week 12

    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.

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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