Dual Task Training On Children With Ataxia After Medulloblastoma Resection

NCT04860934 | Completed DMC

• 1 other identifier: CCHE-BT004
• Study Type: interventional
• Target: 30
• 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. With the goal of, complete resection, major complications during tumor removal are usually caused by damage to the brain stem and injury to the lower cranial nerves.It has been reported that those children present Ataxia after resection. So the purpose of this study is to investigate the effectiveness of using a selected dual-task- training program to improve postural stability in those Children.

Conditions

Medulloblastoma, Childhood; Childhood Cancer

Keywords

Ataxia; Medulloblastoma Resection; posterior fossa tumor; physical activity; Dual Task Training; Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• Dual Task Training program

  Determining the efficacy of "Dual-Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" will be assessed with HUMAC Balance system as indicators of Postural Control

  8 Weeks

Secondary Outcomes (1)

• Ataxia after Medulloblastoma Resection

  8 Weeks

Other Outcomes (2)

• Balance system in children with ataxia after Medulloblastoma Resection

  8 Weeks

• ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection

  8 Weeks

Study Arms (2)

Physical therapy

ACTIVE COMPARATOR

Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks

Behavioral: Control Group

Physical therapy + Dual Task Training Program

EXPERIMENTAL

Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the selected physical therapy program as control group three times weekly for 8 successive weeks.

Behavioral: Dual Task Training Program Group; Behavioral: Control Group

Interventions

Dual Task Training Program Group BEHAVIORAL

Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.

Physical therapy + Dual Task Training Program

Control Group BEHAVIORAL

Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.

Physical therapy; Physical therapy + Dual Task Training Program

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age range from (5-10 years).
• Severity of ataxia will be from 15-30 by SARA scale.
• Children after 2 months of medulloblastoma resection.
• They can stand and walk with minimal support.
• They have good cognition, compliance, and ability to understand and execute test instructions.
• Children receiving radiotherapy and chemotherapy sessions
• They are medically stable

You may not qualify if:

• Children will be excluded from the study if they have
• Any neuromuscular disorder.
• Visual impairment.
• Cognitive problem
• Convulsion.
• Peripheral neuropathy due to chemotherapy.

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)

• Selim FM, Elshafey MA, El-Ayadi MM, Albeltagi DM, Ali MS. Efficacy of dual-task training on stability and function in children with ataxia after medulloblastoma resection: A randomized controlled trial. Pediatr Blood Cancer. 2023 Nov;70(11):e30613. doi: 10.1002/pbc.30613. Epub 2023 Aug 10.

  PMID: 37561355 DERIVED

MeSH Terms

Conditions

Medulloblastoma; Neoplasms; Ataxia; Infratentorial Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fatma Mostafa Sedeek, BSc

  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: March 21, 2021
• First Posted: April 27, 2021
• Study Start: March 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 30, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

EG (1)