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NCT Number: NCT04860934

Dual Task Training On Children With Ataxia After Medulloblastoma Resection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Children will be excluded from the study if they have

  • Any neuromuscular disorder.
  • Visual impairment.
  • Cognitive problem
  • Convulsion.
  • Peripheral neuropathy due to chemotherapy.

Treatment and study plan

Dual Task Training Program Group

Behavioral

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

Control Group

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.

Primary outcomes

  1. Dual Task Training program

    Time frame: 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 outcomes

  1. Ataxia after Medulloblastoma Resection

    Time frame: 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 outcomes

  1. Balance system in children with ataxia after Medulloblastoma Resection

    Time frame: 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).

  2. ADL (activity of daily living) in children with ataxia after Medulloblastoma Resection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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