Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07421505
Brief Summary:
The purpose of this study is to evaluate changes in spinal mobility in the cervical, thoracic, and lumbar regions in children with cerebral palsy aged 10-15 years. The study will compare outcomes between standard NDT-Bobath therapy supplemented with exergaming in a sitting position and exergaming in a standing position. Postural stability, body composition, and functional parameters will also be assessed.
Participants will complete a socio-medical questionnaire and undergo baseline measurements of spinal mobility, cervical range of motion, postural stability (using Podoscan and Zebris platform), body height, and body composition (using SECA stadiometer and Tanita bioimpedance analyzer).
The intervention will last 3 months and include twice-weekly 60-minute therapy sessions. Group I will receive NDT-Bobath therapy supplemented with exergaming in a sitting position, while Group II will receive NDT-Bobath therapy with exergaming in a standing position.
After the intervention, participants will undergo post-intervention measurements and a follow-up evaluation three months later to assess the persistence of any changes.
Detailed Description:
This study aims to evaluate the effects of NDT-Bobath therapy supplemented with exergaming on spinal mobility in children with cerebral palsy (CP) aged 10-15 years. Based on these calculations, a representative study sample includes 42 participants.
Eligible participants are children diagnosed by a physician with spastic diplegia (G80.1) or spastic hemiplegia (G80.2), the two most common clinical phenotypes of CP, representing approximately 35% and 25% of cases, respectively. Participants will be randomly assigned to two intervention groups:
Group I: NDT-Bobath therapy supplemented with exergaming performed in a sitting position.
Group II: NDT-Bobath therapy supplemented with exergaming performed in a standing position.
Participants' data will only be included in the final analysis if their attendance at therapy sessions is at least 85%.
The study will be conducted in four stages:
Stage I - Pilot Study:
A pilot study with 15 participants (who will not participate in the main study) will determine the optimal duration for measuring center-of-pressure sway in children aged 10-15 with CP. Postural stability will be assessed using posturography, Podoscan, and the Zebris platform. Zebris measurements will be dynamic and last 30, 60, and 90 seconds. Baseline assessments will include:
Socio-medical questionnaire covering personal, medical, physiotherapy, educational data, orthopedic equipment usage, physical and therapeutic activities, and nutrition.
Lumbar and thoracic spinal mobility in sagittal and transverse planes and kinematic chain mobility (lumbar spine, pelvic girdle, and lower limbs) using the MyoMotion system.
Cervical spine active range of motion using the CROM device in sagittal, frontal, and horizontal planes.
Body height via SECA 213 stadiometer and body composition (general and segmental fat mass, lean mass, estimated muscle mass) via Tanita bioimpedance analyzer.
Stage II - Intervention:
The intervention program will last 3 months, with 60-minute sessions twice weekly at a collaborating rehabilitation center.
Group I (sitting exergaming): NDT-Bobath therapy with exercises for muscle tone normalization in the pelvic girdle, central stability enhancement including trunk rotation, and exercises for shoulder girdle tone normalization. Therapy sessions follow three core NDT principles: facilitation, stimulation, and communication. Exergaming will be performed in a seated position with hips, knees, and ankles at 90°, allowing gradual position changes between exercises to manage child concentration.
Group II (standing exergaming): NDT-Bobath therapy with similar exercises as Group I, but exergaming performed in a standing position with appropriate posture. Session structure includes adjustments for position changes and attention management.
Participants will be classified according to compensatory patterns:
Type A/A: symmetrical antigravity pattern
Type P/P: symmetrical progravity pattern
Type A/P: mixed antigravity/progravity pattern
Exergaming will use Kinect Therapy-Based Exergames with Microsoft Kinect.
Stage III - Post-intervention Assessment:
Spinal mobility (lumbar, thoracic, cervical) will be reassessed using the same instruments as in Stage I.
Stage IV - Follow-up:
A repeat assessment identical to Stage III will be conducted 3 months after the intervention to evaluate the persistence of therapeutic effects.
Study:
NCT07421505
Study Brief:
Protocol Section:
NCT07421505