Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
Primary Purpose
Ataxia, Medulloblastoma
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dual Task Training (Motor + Cognitive)
Traditional Regular Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Ataxia
Eligibility Criteria
Inclusion Criteria:
All children with the following criteria will be in rolled in the study
- 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 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.
Sites / Locations
- 57357 Children Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual Task Training
Ordinary Physical Therapy for Ataxia
Arm Description
Outcomes
Primary Outcome Measures
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05125666
Brief Title
Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
Official Title
Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia, Medulloblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual Task Training
Arm Type
Experimental
Arm Title
Ordinary Physical Therapy for Ataxia
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dual Task Training (Motor + Cognitive)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Regular Exercise
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
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.
Time Frame
2 months
Title
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.
Time Frame
2 months
Title
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All children with the following criteria will be in rolled in the study
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma M Sedeek, BSc
Phone
01201980290
Email
ptfatmaselim@gmai.com
Facility Information:
Facility Name
57357 Children Cancer Hospital
City
Cairo
State/Province
El Sayeda Zainab
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moatsem El Ayadi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
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