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

NCT ID: NCT05125666

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-03-01

Brief Summary

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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

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Conditions

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Ataxia Medulloblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dual Task Training

Group Type EXPERIMENTAL

Dual Task Training (Motor + Cognitive)

Intervention Type OTHER

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.

Ordinary Physical Therapy for Ataxia

Group Type ACTIVE_COMPARATOR

Traditional Regular Exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Mostafa Sedeek Selim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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57357 Children Cancer Hospital

Cairo, El Sayeda Zainab, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fatma M Sedeek, BSc

Role: CONTACT

Phone: 01201980290

Email: [email protected]

Facility Contacts

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Moatsem El Ayadi, MD

Role: primary

Other Identifiers

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DTT-Ataxia-1

Identifier Type: -

Identifier Source: org_study_id