Clinical trial NCT02979743: MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy
Official title: MRI-based Neuroimaging Predictors of Clinical Improvements Following Occupational Therapy (OT) or OT Puls Acupuncture and Massage Methods in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injury, Chronic
Cerebral Palsy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shenzhen Children's Hospital
name: General Hospital of Ningxia Medical University
name: Xijing Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Shaanxi Provincial People's Hospital
name: Baoji Central Hospital
name: Children's Hospital of Fudan University
name: Hainan People's Hospital
name: Zunyi Medical College
First posted: 2016-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to explore the relationship between brain MRI-metrics and hand function observed in children with cerebral palsy (CP),compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictor of clinical improvement following therapy in children with CP.

Detailed description: Cerebral palsy (CP) is the commonest cause of neurological disability in children. The upper limbs are often affected, with significant hand involvement from an early age.There are various methods of treatment for CP children with hand function disability. However, there is a lack of effective methods to predict the prognosis.

This prospective cohort study will include children with occupational therapy (OT) or OT plus acupuncture and massage methods. Children with CP will be evaluated in terms of upper limb motor function using the manual ability classification system (MACS), fine motor function measure (FMFM). The Brain injuries of Children will be evaluated by MRI.

The aim of this study is to explore the relationship between brain MRI-metrics and hand function, compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictors of clinical improvements following therapy in children with CP.

Eligibility criteria: Inclusion Criteria:

* Age: 3-18 years
* Spastic cerebral palsy
* The complete clinical and MRI data

Exclusion Criteria:

* previous acupuncture and massage methods
* botulinum toxin upper limb injections
* braces artifact, excessive motion, afraid to enter the MRI
* parents were not interested in the MRI sessions

Primary outcomes:
measure: Fine motor function measure (scores)
timeFrame: Baseline
measure: Fine motor function measure (scores)
timeFrame: The 3rd month
Secondary outcomes:
measure: Gross motor function measure and classification system (scores)
timeFrame: Baseline
measure: Gross motor function measure and classification system (scores)
timeFrame: The 3rd month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
citation: Liu H, Jiang H, Wang X, Zheng J, Zhao H, Cheng Y, Tao X, Wang M, Liu C, Huang T, Wu L, Jin C, Li X, Wang H, Yang J. Treatment response prediction of rehabilitation program in children with cerebral palsy using radiomics strategy: protocol for a multicenter prospective cohort study in west China. Quant Imaging Med Surg. 2019 Aug;9(8):1402-1412. doi: 10.21037/qims.2019.04.04.