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Completed

NCT Number: NCT03951246

Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

The purpose of this study is to create a rehabilitation program for children who survived posterior fossa tumors using the latest technology. Supposed that training in Fitlight, Dynavision D2, NeuroTracker will improve executive functions, visual-motor integration, fine and gross motor functions.

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Key information

Conditions

Childhood Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Infratentorial Neoplasms Mental Disorders Motor Skills Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders Neurodevelopmental Disorders Posterior Fossa Tumor

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology

Moscow, 117997, Russia

About this study

The death rates from posterior fossa tumors (PFT) have declined significantly over the past decades. Children and adolescents who survived this kind of tumor without metastases demonstrate 5-year survival rates of 90%. Standard treatment for posterior fossa tumors includes surgical rejection, which can be combined with radiotherapy and chemotherapy. However, treatment factors can cause the impairment of motor and cognitive functions, which influence negatively speech, academic achievements, and quality of life. Such an outcome can be induced by tumor growth process as well. One of the most essential consequences of the disease is cognitive deficiency in the areas of attention, working memory, and executive functions.

The cerebellum pathology often causes deficits of motor skills. Considering that motor system has a hierarchal organization, PFT can cause the impairment of all the system, starting with gross motor skills and ending in the finest eye movements. The cerebellum has been shown to control voluntary eye movements, particularly such parameters as accuracy and velocity of saccades, fixation duration, etc.

Given the effect of probable deficits on a child's daily life, the issue of cognitive and motor remediation programs is in the spotlight today. There is some evidence that interventions targeting cognitive functions (e.g. working memory, short-term memory, attention, planning) and motor skills (gross and fine motor skills, muscle strength, agility) can be effective in these patients.

However, only few of remediation programs focus on visual-motor co-ordination and saccadic eye movements system, despite the fact that they provide the basis for higher-level functions, such as sustained attention, working memory, and planning.

The research conducted in Clinical Rehabilitation Research Center "Russkoe Pole" has revealed that treatment gains in the areas of motor skills, and specifically saccadic eye movements, are positively associated with the enhancement of attention and working memory. Given this, the investigators can suggest that this improvement is connected with the reduction of extra saccadic movements and consequently the decrease of irrelevant information to be processed. This mechanism can be generalized to the other executive functions, such as shifting, inhibition, and planning.

This trial will allow the investigators to determine potential feasibility of rehabilitation program targeting motor and cognitive functions, as well as the saccadic system, in pediatric posterior fossa tumor survivors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Survivor of posterior fossa tumor/healthy control
  • Currently aged 6-17
  • Staying in Clinical Rehabilitation Research Center for 32 days
  • Research participant or legal guardian/representative to give written informed consent

Exclusion criteria

  • Currently on stimulants or other medications intended to treat motor or cognitive impairment
  • History of seizures
  • Severe deficits in vision, motor skills, or cognitive functions
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Treatment and study plan

Cognitive and Motor Training

Other

In the first phase of the trial, all participants (patients and healthy children) will complete cognitive and motor functions assessment.

Then the sample of patients who have cognitive/motor impairment will be randomized to an either Intervention or Control group.

In the second phase of the trial, survivors in the Intervention Group will receive 6 sessions of cognitive and motor training during two weeks, and survivors in Control Group will undergo …..

After this treatment phase, motor and cognitive functions assessment will be conducted in all patients once again.

In the third phase, the Control Group will be provided the active intervention (i.e. 6 sessions of cognitive and motor training during two weeks), while the Intervention Group engages in passive reading.

After this, motor and cognitive functions assessment will be carried out in all patients once again.

Primary outcomes

  1. Eye tracking

    Time frame: Change from Baseline Eye tracking mesuares up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcomes are mesuared: Execution time, Number of Fixations, Scan Path, Mean Duration of Fixations, Mean Saccades Amplitude, Ellipse Square

  2. VMI

    Time frame: Change from Baseline VMI mesuares up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcomes are mesuared: Visual-motor integration, Visual perception, Motor coordination.

  3. Dynavision

    Time frame: Change from Baseline Dynavision mesuare up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcome are mesuared: Reaction Time

  4. Fitlight

    Time frame: Change from Baseline Fitlight mesuare up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcome are mesuared: Reaction Time

  5. Neurotracker

    Time frame: Change from Baseline Neurotracker mesuare up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcome are mesuared: Score

  6. CANTAB

    Time frame: Change from Baseline CANTAB mesuare up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcomes are mesuared: Pattern Recognition Memory Immediate, Pattern Recognition Memory Delayed, Spatial Recognition Memory, Spatial Working Memory (Mistakes), Spatial Working Memory (Strategy), Spatial Span, Rapid Visual Processing (Mistakes), Rapid Visual Processing (Median Latency)

  7. BOT-2

    Time frame: Change from Baseline BOT-2 mesuare up to 2 weeks and follow-up after 4 weeks from Baseline

    Following outcomes are mesuared: Fine Motor Skills, Gross Motor Skills, Coordination, Strength and Agility, General Score

Sponsors and collaborators

Lead sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Other

Registry information

Official study title

The Effect of Cognitive and Motor Training on Executive Functions, Motor Skills, and Saccadic Eye Movements System in Pediatric Posterior Fossa Tumor Survivors

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2019
Registry last updated
May 23, 2019

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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