Effects of Trunk Training in Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Comparison of Effectiveness of Structured Trunk Training Protocols in Patients With Cerebral Palsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04516265
• Other study ID #: Okan U
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: August 2020
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: September 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• neurodevelopmental treatment
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
• video-based trunk training
Games developed for the use of children with cerebral palsy will be used for trunk training.
• Video-based trunk training will apply with Theratogs
Video-based trunk training will apply with Theratogs

Locations

Country	Name	City	State
Turkey	Okan University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Control Measurement Scale	It will be used to evaluate trunk control in patients with CP.	8 weeks
Primary	Trunk Muscle Tone	Trunk Muscle Tone will be evaluated with the Myoton®PRO device.	8 weeks
Primary	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
Primary	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	Pediatric Berg Balance Scale	It will be used to assess functional balance.	8 weeks
Secondary	10-meters walking test	It will be used to evaluate walking.	8 weeks
Secondary	Gillette Functional Gait Assessment Questionaire	It will be used to evaluate functional walking.	8 weeks