Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection

Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)

The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).

Study Overview

• Status: Recruiting
• Conditions: Medulloblastoma; Ataxia
• Intervention / Treatment: Other: Dual Task Training (Motor + Cognitive); Other: Traditional Regular Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fatma M Sedeek, BSc; Phone Number: 01201980290; Email: ptfatmaselim@gmai.com

Study Locations

• Egypt
  • El Sayeda Zainab
    • Cairo, El Sayeda Zainab, Egypt
      • Recruiting
      • 57357 children cancer hospital
      • Contact: Moatsem El Ayadi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All children with the following criteria will be in rolled in the study

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 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dual Task Training	Other: Dual Task Training (Motor + Cognitive); Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks.
ACTIVE_COMPARATOR: Ordinary Physical Therapy for Ataxia	Other: Traditional Regular Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.	2 months
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.	2 months
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.	2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (ACTUAL): November 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; 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; Cerebellar Diseases; Medulloblastoma; Ataxia; Cerebellar Ataxia
• Other Study ID Numbers: DTT-Ataxia-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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