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

Phase 2

• Conditions: Medulloblastoma; Ataxia
• Interventions: Other: Traditional Regular Exercise; Other: Dual Task Training (Motor + Cognitive)

• Registration Number: NCT05125666
• Lead Sponsor: Cairo University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-10-02
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-06
• Last Update Submitted: 2021-11-06
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ordinary Physical Therapy for Ataxia	Traditional Regular Exercise	-
Dual Task Training	Dual Task Training (Motor + Cognitive)	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

57357 Children Cancer Hospital; 🇪🇬 Cairo, El Sayeda Zainab, Egypt