Spinal Mobility in Children With Cerebral Palsy: NDT-Bobath and Exergaming

Официальное название

Spinal Mobility in Children With Cerebral Palsy Undergoing NDT-Bobath Therapy and Exergaming-based Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое NDT-Bobath Therapy
  Standard NDT-Bobath neurodevelopmental therapy focusing on normalization of muscle tone in the pelvic and shoulder girdle, enhancement of central trunk stability including rotational control, and promotion of symmetrical posture and controlled movements according to NDT principles (facilitation, stimulation, communication). Dosage - 60-minute sessions, twice weekly, for 3 months.
• Другое Sitting Exergaming
  Exergaming performed in a seated position using Kinect Therapy-Based Exergames. Participants sit on an adjustable chair with hips, knees, and ankles flexed at 90°. Exercises involve safe, non-impact, visually engaging three-dimensional trunk and limb movements, personalized to the child's functional level. Movements are synchronized with the MyoMotion system for monitoring. Dosage - 60-minute sessions, twice weekly, for 3 months (as part of combined therapy).
• Другое Standing Exergaming
  Exergaming performed in a standing position using Kinect Therapy-Based Exergames, promoting weight-bearing and functional trunk and limb control. Exercises involve safe, visually engaging three-dimensional movements, personalized to the child's functional abilities. Movements are synchronized with the MyoMotion system for real-time monitoring. Dosage - 60-minute sessions, twice weekly, for 3 months (as part of combined therapy).

Первичные конечные точки

• Cervical Spine Mobility [Срок оценки: Baseline, post-intervention (3 months), follow-up (6 months)]
• Thoracic Spine Mobility [Срок оценки: Baseline, post-intervention (3 months), follow-up (6 months)]
• Lumbar Spine Mobility [Срок оценки: Baseline, post-intervention (3 months), follow-up (6 months)]

Критерии участия

Критерии включения

• Written informed consent from parents/guardians and the child (if capable)
• GMFCS levels I-III (mild to moderate motor limitations)
• Ability to maintain standing position
• Ability to follow instructions and perform exercises
• No prior exergaming therapy
• No implanted electronic devices
• No acute infections or inflammatory conditions
• No metabolic disorders affecting bioimpedance measurements

Критерии исключения

• GMFCS levels IV-V
• Orthopedic surgery within the past 12 months
• Seizure episodes within the past 6 months
• Cognitive or behavioral impairments preventing cooperation
• Severe spinal deformities (scoliosis >40° or other significant changes)
• Attendance at therapy sessions <85%

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Польша · 2 центра

• Specjalistyczne Centrum Medyczne im. Jana Pawła II S.A. — Polanica-Zdrój
• Wroclaw University of Health and Sport Sciences — Wroclaw

Идентификаторы

NCT: NCT07421505 · WroclawUHSS Ethics (34/2025)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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