Dual Task Training On Children With Ataxia After Medulloblastoma Resection

Efficacy Of Dual Task Training On Children With Ataxia After Medulloblastoma Resection

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.

Study Overview

• Status: Completed
• Conditions: Medulloblastoma, Childhood; Childhood Cancer
• Intervention / Treatment: Behavioral: Control Group; Behavioral: Dual Task Training Program Group

Detailed Description

Most patients present with symptoms of hydrocephalus due to obstruction by tumor at the level of the fourth ventricle or cerebral aqueduct, and ataxia (Martin et al., 2014). If the tumor is large enough, the lesion itself can also cause mass effect and increased intracranial pressure. Furthermore, direct structural damage from the children can thus present with nausea, vomiting, ataxia,diplopia.

Ataxia in children is a common clinical sign of various origins consisting of impaired coordination of movement and balance with a lack of muscle control during voluntary activity. Ataxia is most frequently caused by dysfunction of the complex circuitry connecting the basal ganglia, cerebellum and cerebral cortex, and this type of involvement is recorded as "cerebellar ataxia.

Recently, the evidence for procedural memory training has advanced sophistication to suggest and ultimately prove that automaticity of a primary (motor task can be developed through exposure to massive repetitions practice) and the forced subconscious processing using dual task interference (Bermúdez, 2017).

The Objectives of the Study:

1- Aim of the Study: Determining the efficacy of "Dual Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" as indicators of Postural Control

2-Specific Objectives:

1. Assess static balance by measuring center of pressure using force plate mode in the humac balance system.
2. Assess dynamic balance by using tilt mode in the humac balance system .
3. Evaluate the improvement on functional status and independence in ADL activities by functional independence measurement.
4. Determine the more effective program for rehabilitation of children with ataxia

3-Secondary Objectives:

1. Assess the degree of ataxia in children after medulloblastoma resection by SARA scale.
2. Detect the effect of cognitive interference on postural stability and balance.
3. Detect if there is improvement in cognitve function after dual task training.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11441
    • Children's Cancer Hospital Egypt 57357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Children will be excluded from the study if they have

1. Any neuromuscular disorder.
2. Visual impairment.
3. Cognitive problem
4. Convulsion.
5. Peripheral neuropathy due to chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical therapy; 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; 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.
Experimental: Physical therapy + Dual Task Training Program; 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: Control Group; 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: Dual Task Training Program Group; Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ataxia after Medulloblastoma Resection	The degree of ataxia will be assessed in children by SARA (Scale of Assessment and Rating of Ataxia) with a scoring scale with minimum value (0, which means there is no Ataxia) and maximum values (40, high score of Ataxia).	8 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance system in children with ataxia after Medulloblastoma Resection	Will be assessed with Pediactris Balance Scale with scoring range with a scoring scale with minimum value (0, which means the child has no balance ) and maximum values (56, which means the child has a good balance score).	8 Weeks
ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection	assessment of ADL (activity of daily living) with functional independence measurement questionnaire which the higher scores mean a better daily activity independence lower score means worse activity with dependency in function.	8 Weeks

Collaborators and Investigators

• Sponsor: Children's Cancer Hospital Egypt 57357
• Investigators: Principal Investigator: Fatma Mostafa Sedeek, BSc, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; Childhood Cancer; Ataxia; posterior fossa tumor; Medulloblastoma Resection; Dual Task Training
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neurologic Manifestations; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Dyskinesias; Neuroectodermal Tumors, Primitive; Medulloblastoma; Ataxia
• Other Study ID Numbers: CCHE-BT004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No