NCT04516265

Brief Summary

The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

July 21, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 13, 2020

Last Update Submit

August 13, 2020

Conditions

Cerebral Palsy

Keywords

trunk trainingtheratogsexercise gamevideo-based training

Outcome Measures

Primary Outcomes (4)

  • Trunk Control Measurement Scale

    It will be used to evaluate trunk control in patients with CP.

    8 weeks

  • Trunk Muscle Tone

    Trunk Muscle Tone will be evaluated with the Myoton®PRO device.

    8 weeks

  • Segmental Assesment of Trunk Control Scale

    It is an evaluation method that allows the body control to be evaluated from 3 different aspects as static, active and reactive control, according to trunk control levels.

    8 weeks

  • Balance Assessment System

    The Fizyosoft Balance Assessment system, which works in harmony with the Nintendo Wii Balance Board, will be used in the assessment of the sitting balance.

    8 weeks

Secondary Outcomes (3)

  • Pediatric Berg Balance Scale

    8 weeks

  • 10-meters walking test

    8 weeks

  • Gillette Functional Gait Assessment Questionaire

    8 weeks

Study Arms (3)

NGT Group

ACTIVE COMPARATOR

A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.

Procedure: neurodevelopmental treatment

Video-based training group

ACTIVE COMPARATOR

Trunk training will be done with games developed for the use of children with cerebral palsy.

Procedure: video-based trunk training

Video-based training group with theratogs

ACTIVE COMPARATOR

Video-based trunk training (45 minutes) will apply with Theratogs to the group

Procedure: Video-based trunk training will apply with Theratogs

Interventions

neurodevelopmental treatmentPROCEDURE

A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.

NGT Group
video-based trunk trainingPROCEDURE

Games developed for the use of children with cerebral palsy will be used for trunk training.

Video-based training group
Video-based trunk training will apply with TheratogsPROCEDURE

Video-based trunk training will apply with Theratogs

Video-based training group with theratogs

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with I-III levels according to Communication Function Classification System
  • Patients with I-III levels according to GMFCS
  • Patients with Hemiparetic Cerebral Palsy
  • Continuing regular physiotherapy and rehabilitation program for six months.

You may not qualify if:

  • Presence of visual or auditory impairment
  • Presence of epilepsy
  • Patients who have undergone orthopedic surgery in the last 6 months
  • Patients who received Botulinum Toxin-A injection in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okan University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Derya Azim Rezaei, MSc

    Okan University,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

  • Burcu Ersöz Hüseyinsinoğlu, Associate professor

    Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 18, 2020

Study Start

July 21, 2020

Primary Completion

July 21, 2021

Study Completion

September 21, 2021

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)