NCT03883815

Brief Summary

In a recent review by Kolobe et al., It was reported that there was no study investigating the effects of treatment intensity on upper or lower extremity function in children with traumatic brain injury and cerebral palsy. In other words, any study in this review reported no studies on the amount of effort or the number of repetitions at high or low intensity. This indicates a clear gap in the literature related to density, which is a dosage variable for cerebral palsy. It is difficult to determine and increase density without having strong, practical methods to measure density during rehabilitation. Therefore, there is a clear need for alternative measurements to measure density. As the alternative measurements, the number of repetitions, the duration of active time during the sessions are used. Energy consumption seen as a useful tool for evaluating functional capacity may also reflect activity intensity by measuring the intensity of activity during the session. Because the ability to perform an activity when interpreted; It is considered as an indicator of fatigue and endurance. Children with cerebral palsy have decreased selective muscle control, abnormal muscle tone, imbalance between agonist and antagonist muscles, and abnormalities in balance due to inadequate balance reactions. Due to all these reasons, cerebral palsy in children has been shown to have higher energy consumption during physical activities such as walking compared to healthy children. Children with cerebral palsy usually have difficulty in regular participation in treatment and adaptation to traditional home exercise programs. Active video games are recommended for use in addition to neurodevelopmental therapy and, in particular, for home use, because of the potential for increasing treatment dosage. Researchers focus on evidence in terms of exercise games, Some games on the market (Wii Sports tennis and boxing and Dance Dance Revolution) have achieved that the physical activity measured by the metabolic equivalent, which is necessary to perform the tasks in individuals with cerebral palsy, is associated with the level of moderate severity. In this study, it is aimed to compare the treatment intensity, performance and balance parameters of the patients with cerebral palsy in a planned neurodevelopmental treatment session and active video games. In this study, the effects of clinical type, age and functional level on treatment intensity, performance and balance parameters during these sessions will be investigated. Hypothesis of the study In line with the needs of children with cerebral palsy, there is a difference in terms of treatment intensity, performance and balance parameters between a planned neurodevelopmental treatment session and active video games.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 10, 2019

Last Update Submit

March 18, 2019

Conditions

Keywords

cerebral palsyneurodevelopmental therapyactive video gamestreatment intensityenergy consumption

Outcome Measures

Primary Outcomes (1)

  • energy consumption

    data on energy consumption during sessions obtained as a result of accelerometer device (in Metabolic Equivalence)

    45 minutes

Secondary Outcomes (2)

  • number of activities

    45 minutes

  • active time during session

    45 minutes

Study Arms (1)

Assesment treatment intensity

Assesment treatment intensity during neurodevelopmental therapy session and active video games therapy session

Other: Active Video Games Therapy

Interventions

Interventions were completed in 1-week periods, after 3 clinical visits. All individuals underwent both neurodevelopmental therapy and active video games therapy. Demographic data of individuals were recorded and muscle tone and gross motor functions were evaluated at the first visit. The games determined by the physiotherapist were explained and experienced by individuals. During the second visit, individuals played 4 games that were previously determined and experienced for about 45 minutes. On the last visit, individuals underwent neurodevelopmental therapy. During both treatment sessions, the accelerometer was fitted on a flexible belt by attaching it to the dominant wrist. Individuals were instructed not to remove the device during both treatment sessions. One session individuals treated with exercises which weight transfer and postural reactions were facilitated. Other session they played Nintendo Wii games in accordance with their current level and skills.

Also known as: Neurodevelopmental therapy
Assesment treatment intensity

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals with a diagnosis of Cerebral Palsy who had been undergoing physiotherapy for 2 days a week between the ages of 6 and 18 were included in the study.

You may qualify if:

  • Having a diagnosis of cerebral palsy by a qualified physician, between the ages of 6-18 and continuing ambulations,
  • Functional to Gross Motor Function Classification System be between levels I-III,
  • To be cooperative during the evaluation and treatment sessions,
  • Individuals do not have a history of genetic and / or neurological disease other than cerebral palsy,
  • In terms of the movements of the upper extremities; Should be able to shoulder flexion up to 90 degrees, have enough functional hand ability to grasp the Nintendo Wii control, actively flex elbow and extension within the functional limits, lack of spasticity of the upper extremity muscles which may interfere with all these movements,
  • To be able to play the game with sufficient balance to be able to stand,
  • Have not played Nintendo Wii before,
  • There is no defect in the visual functions except breakage defect

You may not qualify if:

  • Passing muscle-tendon and bone operation less than 6 months ago,
  • have been exposed to any pharmacological agent to inhibit spasticity within 6 months,
  • have cognitive / mental problems that will interfere with communication with him / she will not understand working instructions,
  • Difficulty in visual functions except for fracture failure,
  • A history of genetic and / or neurological disease other than cerebral palsy,
  • The patient was negatively affected by physical activity and was diagnosed as having epileptic seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Eyalet/Yerleşke, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant, doctor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 21, 2019

Study Start

August 15, 2017

Primary Completion

August 15, 2018

Study Completion

November 15, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations