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Dual Task Training On Children With Ataxia After Medulloblastoma Resection

Primary Purpose

Medulloblastoma, Childhood, Childhood Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dual Task Training Program Group
Control Group
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 Medulloblastoma, Childhood focused on measuring Ataxia, Medulloblastoma Resection, posterior fossa tumor, physical activity, Dual Task Training, Childhood Cancer

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physical therapy

Physical therapy + Dual Task Training Program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
March 21, 2021
Last Updated
November 7, 2022
Sponsor
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT04860934
Brief Title
Dual Task Training On Children With Ataxia After Medulloblastoma Resection
Official Title
Efficacy Of Dual Task Training On Children With Ataxia After Medulloblastoma Resection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 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. 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.
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: Assess static balance by measuring center of pressure using force plate mode in the humac balance system. Assess dynamic balance by using tilt mode in the humac balance system . Evaluate the improvement on functional status and independence in ADL activities by functional independence measurement. Determine the more effective program for rehabilitation of children with ataxia 3-Secondary Objectives: Assess the degree of ataxia in children after medulloblastoma resection by SARA scale. Detect the effect of cognitive interference on postural stability and balance. Detect if there is improvement in cognitve function after dual task training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma, Childhood, Childhood Cancer
Keywords
Ataxia, Medulloblastoma Resection, posterior fossa tumor, physical activity, Dual Task Training, Childhood Cancer

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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Physical therapy + Dual Task Training Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dual Task Training Program Group
Intervention Description
Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dual Task Training program
Description
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
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Ataxia after Medulloblastoma Resection
Description
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).
Time Frame
8 Weeks
Other Pre-specified Outcome Measures:
Title
Balance system in children with ataxia after Medulloblastoma Resection
Description
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).
Time Frame
8 Weeks
Title
ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection
Description
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.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Children will be excluded from the study if they have Any neuromuscular disorder. Visual impairment. Cognitive problem Convulsion. Peripheral neuropathy due to chemotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Mostafa Sedeek, BSc
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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Dual Task Training On Children With Ataxia After Medulloblastoma Resection

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