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

Medulloblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125666
• Other study ID #: DTT-Ataxia-1
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Medulloblastoma

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