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

NCT04528316 | Completed DMC

• 1 other identifier: CCHE-BT003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Fossa Tumor; Medulloblastoma, Childhood

Keywords

physical activity; postural stability; coordination; posterior fossa tumor

Outcome Measures

Primary Outcomes (1)

• Change Balance

  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 Outcomes (1)

• Change Coordination

  at week 12

Study Arms (3)

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:

Behavioral: Pilates Core Stability Exercises program

Balance Group

EXPERIMENTAL

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; Behavioral: Balance Program

Coordination Group

EXPERIMENTAL

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; Behavioral: Coordination

Interventions

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: 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:

Balance Group; Control Group/Pilates Core Stability Exercises program Group; Coordination Group

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).

Also known as: HUMAC program

Balance Group

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.

Coordination Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Location

Related Publications (1)

• Usama M, Abdelaziem F, Rashed WM, Maher E, El Beltagy M, Zekri W. Impact of physical activity on postural stability and coordination in children with posterior fossa tumor: randomized control phase III trial. J Cancer Res Clin Oncol. 2023 Aug;149(9):5637-5644. doi: 10.1007/s00432-022-04490-4. Epub 2022 Dec 16.

  PMID: 36525069 DERIVED

MeSH Terms

Conditions

Infratentorial Neoplasms; Medulloblastoma; Motor Activity

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Behavior

Study Officials

• Mahmoud Usama Mahmoud Ahmed, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: August 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

EG (1)