Dual Task Training On Children With Ataxia After Medulloblastoma Resection

November 7, 2022 updated by: Children's Cancer Hospital Egypt 57357

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dual Task Training program
Time Frame: 8 Weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ataxia after Medulloblastoma Resection
Time Frame: 8 Weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance system in children with ataxia after Medulloblastoma Resection
Time Frame: 8 Weeks
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
Time Frame: 8 Weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Cancer Hospital Egypt 57357

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma Mostafa Sedeek, BSc, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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