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

Primary Purpose

Posterior Fossa Tumor, Medulloblastoma, Childhood

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates Core Stability Exercises program
Balance Program
Coordination
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Fossa Tumor focused on measuring physical activity, postural stability, coordination, posterior fossa tumor

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group/Pilates Core Stability Exercises program Group

Balance Group

Coordination Group

Arm 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: 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:

Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program

Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change Coordination
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.

Full Information

First Posted
August 24, 2020
Last Updated
August 3, 2021
Sponsor
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT04528316
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Fossa Tumor, Medulloblastoma, Childhood
Keywords
physical activity, postural stability, coordination, posterior fossa tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group/Pilates Core Stability Exercises program Group
Arm Type
Active Comparator
Arm 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: 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:
Arm Title
Balance Group
Arm Type
Experimental
Arm Description
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program
Arm Title
Coordination Group
Arm Type
Experimental
Arm Description
Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises.
Intervention Type
Behavioral
Intervention Name(s)
Pilates Core Stability Exercises program
Intervention 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: 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:
Intervention Type
Behavioral
Intervention Name(s)
Balance Program
Other Intervention Name(s)
HUMAC program
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Coordination
Intervention Description
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 Measure Information:
Title
Change Balance
Description
For assessment of the three groups, HUMAC balance and tilt system will be used to assess both Static and dynamic balance.
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Change Coordination
Description
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.
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Usama Mahmoud Ahmed, MSc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Cancer Hospital Egypt 57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt

12. IPD Sharing Statement

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

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