- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421505
Spinal Mobility in Children With Cerebral Palsy: NDT-Bobath and Exergaming
Spinal Mobility in Children With Cerebral Palsy Undergoing NDT-Bobath Therapy and Exergaming-based Therapy
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aleksandra Kopaczyńska, Master of Science
- Phone Number: +48601157773
- Email: aleksandra.kopaczynska@awf.wroc.pl
Study Locations
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Lower Silesian Voivodeship
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Polanica-Zdrój, Lower Silesian Voivodeship, Poland, 57-320
- Specjalistyczne Centrum Medyczne im. Jana Pawła II S.A.
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Contact:
- Aleksandra Kopaczyńska, Master of Science
- Phone Number: +48601157773
- Email: aleksandra.kopaczynska@awf.wroc.pl
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Principal Investigator:
- Aleksandra Kopaczyńska, Master of Science
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Wroclaw, Lower Silesian Voivodeship, Poland, 51-612
- Wroclaw University of Health and Sport Sciences
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Contact:
- Aleksandra Kopaczyńska, Master of Science
- Phone Number: +48601157773
- Email: aleksandra.kopaczynska@awf.wroc.pl
-
Principal Investigator:
- Aleksandra Kopaczyńska, Master of Science
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NDT-Bobath + Sitting Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a seated position. Therapy sessions will last 60 minutes, twice weekly, for 3 months. The NDT-Bobath component focuses on: Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication) The exergaming component will be performed while seated on a chair with adjustable height to achieve 90° flexion at hips, knees, and ankles. Exercises will engage three-dimensional trunk and limb movements, be visually engaging, and allow personalization according to each child's functional level. Exercises are safe, non-impact, and synchronized with the MyoMotion system for monitoring. |
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.
Other Names:
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).
Other Names:
|
|
Experimental: NDT-Bobath + Standing Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a standing position. Therapy sessions will last 60 minutes, twice weekly, for 3 months. The NDT-Bobath component focuses on: Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication) The exergaming component will be performed in a standing position, promoting weight-bearing and functional trunk and limb control. Exercises engage three-dimensional movements, are visually appealing, and personalized according to the child's functional abilities. Exercise intensity is safe and designed to prevent injury, with position adjustments between exercises as needed. Exercises are synchronized with the MyoMotion system for real-time monitoring. |
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.
Other Names:
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Spine Mobility
Time Frame: Baseline, post-intervention (3 months), follow-up (6 months)
|
Change in active cervical spine range of motion in children with cerebral palsy aged 10-15 years, measured in sagittal, frontal, and transverse planes using the CROM device.
Cervical flexion/extension, lateral flexion, and rotation are expressed in degrees.
|
Baseline, post-intervention (3 months), follow-up (6 months)
|
|
Thoracic Spine Mobility
Time Frame: Baseline, post-intervention (3 months), follow-up (6 months)
|
Change in thoracic spine mobility measured as active range of motion and trunk rotation using the MyoMotion system.
Measurements are expressed in degrees and reflect thoracic flexion/extension, lateral flexion, and rotational movements.
|
Baseline, post-intervention (3 months), follow-up (6 months)
|
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Lumbar Spine Mobility
Time Frame: Baseline, post-intervention (3 months), follow-up (6 months)
|
Change in lumbar spine mobility measured as active range of motion using the MyoMotion system.
Lumbar flexion/extension, lateral flexion, and rotation are expressed in degrees.
|
Baseline, post-intervention (3 months), follow-up (6 months)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WroclawUHSS Ethics (34/2025)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
At this time, a final decision has not been made regarding the sharing of de-identified individual participant data (IPD). Potentially shareable data would include de-identified demographic information and outcome data relevant to the primary and secondary endpoints of the study.
The decision regarding IPD sharing will be made after completion of the study and final data analyses. This is due to the need to evaluate:
- compliance with applicable data protection and privacy regulations,
- limitations related to the informed consent obtained from participants,
- potential contractual or institutional obligations,
- the risk of participant re-identification despite data de-identification. Following study completion and publication of results, the possibility of sharing IPD will be reconsidered.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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