Effects of Trunk Training in Patients With Cerebral Palsy

Not Applicable

• Conditions: Cerebral Palsy
• Interventions: Procedure: video-based trunk training; Procedure: neurodevelopmental treatment; Procedure: Video-based trunk training will apply with Theratogs

• Registration Number: NCT04516265
• Lead Sponsor: Okan University

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.

Study Timeline

• Study Start: 2020-07-21
• Status Verified: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-13
• Study First Posted: 2020-08-18
• Last Update Posted: 2020-08-18
• Primary Completion: 2021-07-21
• Study Completion: 2021-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video-based training group	video-based trunk training	Trunk training will be done with games developed for the use of children with cerebral palsy.
NGT Group	neurodevelopmental treatment	A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
Video-based training group with theratogs	Video-based trunk training will apply with Theratogs	Video-based trunk training (45 minutes) will apply with Theratogs to the group

Primary Outcome Measures

Name	Time	Method
Trunk Control Measurement Scale	8 weeks	It will be used to evaluate trunk control in patients with CP.
Trunk Muscle Tone	8 weeks	Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
Segmental Assesment of Trunk Control Scale	8 weeks	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	8 weeks	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

Name	Time	Method
Pediatric Berg Balance Scale	8 weeks	It will be used to assess functional balance.
Gillette Functional Gait Assessment Questionaire	8 weeks	It will be used to evaluate functional walking.
10-meters walking test	8 weeks	It will be used to evaluate walking.

Trial Locations

Locations (1)

Okan University; 🇹🇷 Istanbul, Turkey