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Is it possible to predict the effect of balance training based on networks in the brain in children with cerebral palsy?

Responding or not responding to training; Prediction of balance Rehabilitation Outcome from structural and functional brain networks in Cerebral Palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29671
Enrollment
51
Registered
2016-08-26
Start date
2016-09-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired balance control in children with spastic cerebral palsy

Interventions

For balance training the latest serious gaming product
X-box One Kinect (Microsoft) will be used. The 31 children with cerebral palsy in the intervention group and the 10 typically developing children will undergo a 6 week training program (5x/week, 30mi

Sponsors

Project leader; Prof. Dr. J.G. Becher Principal investigator: Dr. Pieter Meyns Sponsor: VU University Medical Center Amsterdam Dept. of Rehabilitation Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • diagnosis of bilateral spastic CP, lower limbs more involved than the upper limbs;* • 8-14 years; • GMFCS level 2;* • able to stand independently for 2 min; • Child and Parent/guardian consent; • Sufficient cooperation & cognitive skills: able to follow simple instructions & complete the measurements. • MRI can be performed without general anesthesia. * criteria for children with CP, not for the typically developing control children.

Exclusion criteria

Exclusion criteria: • orthopaedic surgery or other surgery in the past twelve months that might influence mobility; • Botulinum Toxin A injections in the past six months; • Selective dorsal rhizotomy (SDR) in the past year; • Vestibular deficits, benign vertigo or unstable epilepsy; • Claustrophobia; • Pacemaker or other non-removable magnetic metal-containing objects; • Not able to lie still for the duration of the scan; • Not willing to hear about ‘incidental findings’, potential unforeseen, clinically relevant abnormalities found in the MRI images

Design outcomes

Primary

MeasureTime frame
The Pediatric Balance Scale (PBS) will be evaluated as the main outcome of balance control.

Secondary

MeasureTime frame
Additional balance control measures, such as: 1. ‘balance’ and ‘running speed and agility’ subtest of the Bruininks-Oseretsky Test of Motor Proficiency 2. Trunk Control Measurement Scale 3. Sensory Organization Test 4. Spatio-temporal and kinematic gait parameters during unperturbed and perturbed walking 5. Maximum Lyapunov Exponents 6. Gait sensitivity Norm 7. Foot Placement Estimator Magnetic Resonance Imaging (MRI) measures of the brain, such as: 1. structural brain Magnetic Resonance Imaging scans (T1 & FLAIR) 2. Diffusion tensor imaging scans 3. resting-state functional MRI scans

Contacts

Public ContactJ.G. Becher

VU University Medical Center, P.O. Box 7057

reva@vumc.nl+31 (0)20 4440763

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)