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

August 3, 2021 updated by: Children's Cancer Hospital Egypt 57357

Impact of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11441
        • Children's Cancer Hospital Egypt 57357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control Group/Pilates Core Stability Exercises program Group

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:
Behavioral: Pilates Core Stability Exercises program

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:
EXPERIMENTAL: Balance Group
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program
Behavioral: Pilates Core Stability Exercises program

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:
Behavioral: Balance Program
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
EXPERIMENTAL: Coordination Group
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises.
Behavioral: Pilates Core Stability Exercises program

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:
Behavioral: Coordination

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Hospital Egypt 57357

Investigators

  • Principal Investigator: Mahmoud Usama Mahmoud Ahmed, MSc, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 6, 2020

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (ACTUAL)

August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHE-BT003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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