Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

NCT ID: NCT03951246

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-05-21

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Training Group

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.

Group Type: EXPERIMENTAL

Cognitive and Motor Training

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive and Motor Training

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

8э/15-17

Identifier Type: -

Identifier Source: org_study_id