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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528316
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357

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.

Condition or disease Intervention/treatment Phase
Posterior Fossa Tumor Medulloblastoma, Childhood Behavioral: Pilates Core Stability Exercises program Behavioral: Balance Program Behavioral: Coordination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021


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 Name: 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528316


Contacts
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Contact: Wafaa Rashed 01145116505 wafaaanor@gmail.com

Locations
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Egypt
Children's Cancer Hospital Egypt 57357 Recruiting
Cairo, Egypt, 11441
Contact: wafaa Rashed, MSc    +225351500 ext 7209    waffa.rashed@57357.com   
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
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Principal Investigator: Mahmoud Usama Mahmoud Ahmed, MSc Cairo University
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Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT04528316    
Other Study ID Numbers: CCHE-BT003
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Cancer Hospital Egypt 57357:
physical activity
postural stability
coordination
posterior fossa tumor
Additional relevant MeSH terms:
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Medulloblastoma
Infratentorial Neoplasms
Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases