Dual Task Training On Children With Ataxia After Medulloblastoma Resection

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860934
• Other study ID #: CCHE-BT004
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2022
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Childhood Cancer
• Medulloblastoma
• Medulloblastoma, Childhood

Intervention

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

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Balance system in children with ataxia after Medulloblastoma Resection	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).	8 Weeks
Other	ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection	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.	8 Weeks
Primary	Dual Task Training program	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	8 Weeks
Secondary	Ataxia after Medulloblastoma Resection	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).	8 Weeks