Clinical trial NCT04516265: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: trunk training
theratogs
exercise game
video-based training
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trunk Control Measurement Scale
timeFrame: 8 weeks
measure: Trunk Muscle Tone
timeFrame: 8 weeks
measure: Segmental Assesment of Trunk Control Scale
timeFrame: 8 weeks
measure: Balance Assessment System
timeFrame: 8 weeks
Secondary outcomes:
measure: Pediatric Berg Balance Scale
timeFrame: 8 weeks
measure: 10-meters walking test
timeFrame: 8 weeks
measure: Gillette Functional Gait Assessment Questionaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University
Study officials:
affiliation: Okan University,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
name: Derya Azim Rezaei, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
name: Burcu Ersöz Hüseyinsinoğlu, Associate professor
role: STUDY_DIRECTOR
References: