Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

NCT03951246 | Completed

• 1 other identifier: 8э/15-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer; Cognitive Impairment; Motor Skills Disorders; Posterior Fossa Tumor

Keywords

executive functions; motor skills; eye tracking; pediatric cancer; posterior fossa tumors

Outcome Measures

Primary Outcomes (7)

• Eye tracking

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

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

• VMI

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

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

• Dynavision

  Following outcome are mesuared: Reaction Time

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

• Fitlight

  Following outcome are mesuared: Reaction Time

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

• Neurotracker

  Following outcome are mesuared: Score

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

• CANTAB

  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)

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

• BOT-2

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

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

Study Arms (2)

Training Group

EXPERIMENTAL

Training Group recieved cognitive and Motor training included 6 sessions using the following training devices. * Dynavision D2 ® (USA) (https://products.dynavisioninternational.com/products/d2) presents a panel with 64 bulbs which take the form of five circles. The task of a participant is to press the bulb that is glowing as quick as possible. In the trial 8 modes will be used; they have different instructions which are aimed at visual-motor co-ordination, processing speed, inhibition, and shifting. * Fitlight Trainer ® (Canada) (https://www.fitlighttraining.com) consists of 7 clickers, and the tasks are similar to Dynavision ones. * NeuroTracker ® (Canada) (https://neurotracker.net) includes a task of multiple object training for working memory and attention enhancement.

Other: Cognitive and Motor Training

Control Group

NO INTERVENTION

Control Group didn't recieved any cognitive and motor training. They visited swimming pool and physical therapy.

Interventions

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.

Training Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

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

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction; Motor Skills Disorders; Infratentorial Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurodevelopmental Disorders; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: May 15, 2019
• Study Start: November 1, 2017
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)