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Clinical Trials/NCT04528316
NCT04528316CompletedNot Applicable

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

Children's Cancer Hospital Egypt 573571 site in 1 country60 target enrollmentStarted: August 6, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Change Balance

Study Overview

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:

  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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control Group/Pilates Core Stability Exercises program Group

Active Comparator

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:

Intervention: Pilates Core Stability Exercises program (Behavioral)

Balance Group

Experimental

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

Intervention: Pilates Core Stability Exercises program (Behavioral)

Balance Group

Experimental

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

Intervention: Balance Program (Behavioral)

Coordination Group

Experimental

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

Intervention: Pilates Core Stability Exercises program (Behavioral)

Coordination Group

Experimental

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

Intervention: Coordination (Behavioral)

Outcomes

Primary Outcomes

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

  • Change Coordination(at week 12)

Investigators

Sponsor
Children's Cancer Hospital Egypt 57357
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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