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Spastic Diplegia Cerebral PalsyNCT07421505

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

A study testing NDT-Bobath Therapy, Sitting Exergaming and Standing Exergaming in people with Spastic Diplegia Cerebral Palsy and Spastic Hemiplegia, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
NDT-Bobath Therapy, Sitting Exergaming and Standing Exergaming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesPoland
Study dates
Feb 2026to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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%

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aleksandra Kopaczyńska, Master of Science contact

+48601157773

aleksandra.kopaczynska@awf.wroc.pl

Poland2 sites
  • Specjalistyczne Centrum Medyczne im. Jana Pawła II S.A.

    Polanica-Zdrój, Lower Silesian Voivodeship, 57-320

    Aleksandra Kopaczyńska, Master of Science, +48601157773, aleksandra.kopaczynska@awf.wroc.pl

    Aleksandra Kopaczyńska, Master of Science

  • Wroclaw University of Health and Sport Sciences

    Wroclaw, Lower Silesian Voivodeship, 51-612

    Aleksandra Kopaczyńska, Master of Science, +48601157773, aleksandra.kopaczynska@awf.wroc.pl

    Aleksandra Kopaczyńska, Master of Science

Other trials in Poland

About this study

Official title: 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).

Read more

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.

Read the 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.

Being tested
NDT-Bobath Therapy, Sitting Exergaming, Standing Exergaming
Keywords
Cerebral palsy, Spinal mobility, NDT-Bobath therapy, Exergaming
Medical subject headings
Cerebral palsy, spastic, diplegic, Hemiplegia, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDT-Bobath TherapyOther

    Also called Neurodevelopmental Treatment (Bobath Concept)

    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.

  • Sitting ExergamingOther

    Also called Seated 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).

  • Standing ExergamingOther

    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).

Study groups in NCT07421505
Study groupRoleWhat they receive
NDT-Bobath + Sitting ExergamingExperimentalParticipants 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.
Receives: Other: NDT-Bobath Therapy; Other: Sitting Exergaming
NDT-Bobath + Standing ExergamingExperimentalParticipants 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.
Receives: Other: NDT-Bobath Therapy; Other: Standing Exergaming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, post-intervention (3 months), follow-up (6 months)

  2. 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.

    Measured: Baseline, post-intervention (3 months), follow-up (6 months)

  3. 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.

    Measured: Baseline, post-intervention (3 months), follow-up (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421505
Sponsor's protocol ID
WroclawUHSS Ethics (34/2025)
Status last verified
Feb 2026
First submitted
28 Jan 2026
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing NDT-Bobath Therapy, Sitting Exergaming and Standing Exergaming in people with Spastic Diplegia Cerebral Palsy and Spastic Hemiplegia, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksandra Kopaczyńska, Master of Science (+48601157773, aleksandra.kopaczynska@awf.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Spine Mobility (time frame: Baseline, post-intervention (3 months), follow-up (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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