Dual Task Training On Children With Ataxia After Medulloblastoma Resection

Sponsor

Children's Cancer Hospital Egypt 57357 (Other)

Overall Status

Recruiting

CT.gov ID

NCT04860934

Collaborator

(none)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Medulloblastoma, Childhood Childhood Cancer	Behavioral: Dual Task Training Program Group Behavioral: Control Group	N/A

Detailed Description

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:

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

3-Secondary Objectives:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy Of Dual Task Training On Children With Ataxia After Medulloblastoma Resection

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Nov 15, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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.
Experimental: 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.	Behavioral: Dual Task Training Program Group Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks. 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.

Arm

Intervention/Treatment

Active Comparator: 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

Behavioral: Control Group

Experimental: 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.

Behavioral: Dual Task Training Program Group

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

Behavioral: Control Group

Outcome Measures

Primary Outcome Measures

Dual Task Training program [8 Weeks]
Determining the efficacy of "Dual-Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" will be assessed with HUMAC Balance system as indicators of Postural Control

Secondary Outcome Measures

Ataxia after Medulloblastoma Resection [8 Weeks]
The degree of ataxia will be assessed in children by SARA (Scale of Assessment and Rating of Ataxia) with a scoring scale with minimum value (0, which means there is no Ataxia) and maximum values (40, high score of Ataxia).

Other Outcome Measures

Balance system in children with ataxia after Medulloblastoma Resection [8 Weeks]
Will be assessed with Pediactris Balance Scale with scoring range with a scoring scale with minimum value (0, which means the child has no balance ) and maximum values (56, which means the child has a good balance score).
ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection [8 Weeks]
assessment of ADL (activity of daily living) with functional independence measurement questionnaire which the higher scores mean a better daily activity independence lower score means worse activity with dependency in function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age range from (5-10 years).
Severity of ataxia will be from 15-30 by SARA scale.
Children after 2 months of medulloblastoma resection.
They can stand and walk with minimal support.
They have good cognition, compliance, and ability to understand and execute test instructions.
Children receiving radiotherapy and chemotherapy sessions
They are medically stable