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Effects of Trunk Training in Patients With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neurodevelopmental treatment
video-based trunk training
Video-based trunk training will apply with Theratogs
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring trunk training, theratogs, exercise game, video-based training

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Okan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

NGT Group

Video-based training group

Video-based training group with theratogs

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Trunk Control Measurement Scale
It will be used to evaluate trunk control in patients with CP.
Trunk Muscle Tone
Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
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.
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.

Secondary Outcome Measures

Pediatric Berg Balance Scale
It will be used to assess functional balance.
10-meters walking test
It will be used to evaluate walking.
Gillette Functional Gait Assessment Questionaire
It will be used to evaluate functional walking.

Full Information

First Posted
August 13, 2020
Last Updated
August 13, 2020
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04516265
Brief Title
Effects of Trunk Training in Patients With Cerebral Palsy
Official Title
The Comparison of Effectiveness of Structured Trunk Training Protocols in Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Anticipated)
Study Completion Date
September 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. It is planned to include 45 patients with hemiparetic cerebral palsy between the ages of 5-15 and with Gross Motor Function Classification System (GMFCS) level I-III. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
trunk training, theratogs, exercise game, video-based training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NGT Group
Arm Type
Active Comparator
Arm Description
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
Arm Title
Video-based training group
Arm Type
Active Comparator
Arm Description
Trunk training will be done with games developed for the use of children with cerebral palsy.
Arm Title
Video-based training group with theratogs
Arm Type
Active Comparator
Arm Description
Video-based trunk training (45 minutes) will apply with Theratogs to the group
Intervention Type
Procedure
Intervention Name(s)
neurodevelopmental treatment
Intervention Description
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
Intervention Type
Procedure
Intervention Name(s)
video-based trunk training
Intervention Description
Games developed for the use of children with cerebral palsy will be used for trunk training.
Intervention Type
Procedure
Intervention Name(s)
Video-based trunk training will apply with Theratogs
Intervention Description
Video-based trunk training will apply with Theratogs
Primary Outcome Measure Information:
Title
Trunk Control Measurement Scale
Description
It will be used to evaluate trunk control in patients with CP.
Time Frame
8 weeks
Title
Trunk Muscle Tone
Description
Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
Time Frame
8 weeks
Title
Segmental Assesment of Trunk Control Scale
Description
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.
Time Frame
8 weeks
Title
Balance Assessment System
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pediatric Berg Balance Scale
Description
It will be used to assess functional balance.
Time Frame
8 weeks
Title
10-meters walking test
Description
It will be used to evaluate walking.
Time Frame
8 weeks
Title
Gillette Functional Gait Assessment Questionaire
Description
It will be used to evaluate functional walking.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Azim Rezaei, MSc
Organizational Affiliation
Okan University,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burcu Ersöz Hüseyinsinoğlu, Associate professor
Organizational Affiliation
Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Okan University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Trunk Training in Patients With Cerebral Palsy

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