Dual Task Training On Children With Ataxia After Medulloblastoma Resection

NCT ID: NCT04860934

Last Updated: 2022-11-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-11-30

Brief Summary

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Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. With the goal of, complete resection, major complications during tumor removal are usually caused by damage to the brain stem and injury to the lower cranial nerves.It has been reported that those children present Ataxia after resection. So the purpose of this study is to investigate the effectiveness of using a selected dual-task- training program to improve postural stability in those Children.

Detailed Description

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Most patients present with symptoms of hydrocephalus due to obstruction by tumor at the level of the fourth ventricle or cerebral aqueduct, and ataxia (Martin et al., 2014). If the tumor is large enough, the lesion itself can also cause mass effect and increased intracranial pressure. Furthermore, direct structural damage from the children can thus present with nausea, vomiting, ataxia,diplopia.

Ataxia in children is a common clinical sign of various origins consisting of impaired coordination of movement and balance with a lack of muscle control during voluntary activity. Ataxia is most frequently caused by dysfunction of the complex circuitry connecting the basal ganglia, cerebellum and cerebral cortex, and this type of involvement is recorded as "cerebellar ataxia.

Recently, the evidence for procedural memory training has advanced sophistication to suggest and ultimately prove that automaticity of a primary (motor task can be developed through exposure to massive repetitions practice) and the forced subconscious processing using dual task interference (Bermúdez, 2017).

The Objectives of the Study:

1- Aim of the Study: Determining the efficacy of "Dual Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" as indicators of Postural Control

2-Specific Objectives:

1. Assess static balance by measuring center of pressure using force plate mode in the humac balance system.
2. Assess dynamic balance by using tilt mode in the humac balance system .
3. Evaluate the improvement on functional status and independence in ADL activities by functional independence measurement.
4. Determine the more effective program for rehabilitation of children with ataxia

3-Secondary Objectives:

1. Assess the degree of ataxia in children after medulloblastoma resection by SARA scale.
2. Detect the effect of cognitive interference on postural stability and balance.
3. Detect if there is improvement in cognitve function after dual task training.

Conditions

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Medulloblastoma, Childhood Childhood Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physical therapy

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

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.

Physical therapy + Dual Task Training Program

Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the selected physical therapy program as control group three times weekly for 8 successive weeks.

Group Type EXPERIMENTAL

Dual Task Training Program Group

Intervention Type BEHAVIORAL

Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.

Control Group

Intervention Type BEHAVIORAL

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 Program Group

Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.

Intervention Type BEHAVIORAL

Control Group

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 BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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 execute test 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

No

Sponsors

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Children's Cancer Hospital Egypt 57357

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatma Mostafa Sedeek, BSc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Children's Cancer Hospital Egypt 57357

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Selim FM, Elshafey MA, El-Ayadi MM, Albeltagi DM, Ali MS. Efficacy of dual-task training on stability and function in children with ataxia after medulloblastoma resection: A randomized controlled trial. Pediatr Blood Cancer. 2023 Nov;70(11):e30613. doi: 10.1002/pbc.30613. Epub 2023 Aug 10.

Reference Type DERIVED
PMID: 37561355 (View on PubMed)

Other Identifiers

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CCHE-BT004

Identifier Type: -

Identifier Source: org_study_id

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