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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 28, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Cerebral palsySpinal mobilityNDT-Bobath therapyExergaming

Outcome Measures

Primary Outcomes (3)

  • Cervical Spine Mobility

    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

    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)

  • Lumbar Spine Mobility

    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)

Study Arms (2)

NDT-Bobath + Sitting Exergaming

EXPERIMENTAL

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.

Other: NDT-Bobath TherapyOther: Sitting Exergaming

NDT-Bobath + Standing Exergaming

EXPERIMENTAL

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.

Other: NDT-Bobath TherapyOther: Standing Exergaming

Interventions

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.

Also known as: Neurodevelopmental Treatment (Bobath Concept)
NDT-Bobath + Sitting ExergamingNDT-Bobath + Standing 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).

Also known as: Seated Exergaming
NDT-Bobath + Sitting 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).

NDT-Bobath + Standing Exergaming

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Specjalistyczne Centrum Medyczne im. Jana Pawła II S.A.

Polanica-Zdrój, Lower Silesian Voivodeship, 57-320, Poland

Location

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegicHemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Aleksandra Kopaczyńska, Master of Science

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The participants will be randomly assigned to one of two groups. Group I: NDT-Bobath therapy supplemented with exergaming performed in a sitting position using Kinect Therapy-Based Exergames. Group II: NDT-Bobath therapy supplemented with exergaming performed in a standing position using the same systems.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 19, 2026

Study Start

February 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations