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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05125666
Other study ID # DTT-Ataxia-1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2020
Est. completion date March 1, 2022

Study information

Verified date November 2021
Source Cairo University
Contact Fatma M Sedeek, BSc
Phone 01201980290
Email ptfatmaselim@gmai.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Egypt 57357 Children Cancer Hospital Cairo El Sayeda Zainab

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system. 2 months
Primary Improvement in Activities of Daily Living (ADL) measured by functional independence measurement. 2 months
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