MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy

Not Applicable

• Conditions: Brain Injury, Chronic; Cerebral Palsy
• Interventions: Behavioral: Occupational therapy; Other: Occupational therapy puls acupuncture and massage methods

• Registration Number: NCT02979743
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-29
• Study Start: 2016-12
• Study First Posted: 2016-12-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occupational therapy group	Occupational therapy	The children worked with an occupational therapist for 4 hours a day for 5 days per week (totaling 40 hours) and initially concentrated on unilateral activities with the hemiplegic hand,and added bilateral activities during the second week.
Occupational therapy puls acupuncture and massage methods	Occupational therapy	The patients receive occupational therapy puls acupuncture and massage methods.
Occupational therapy puls acupuncture and massage methods	Occupational therapy puls acupuncture and massage methods	The patients receive occupational therapy puls acupuncture and massage methods.

Primary Outcome Measures

Name	Time	Method
Fine motor function measure (scores)	The 3rd month	It is acquired at 3 months later following therapy.

Secondary Outcome Measures

Name	Time	Method
Gross motor function measure and classification system (scores)	The 3rd month	It is acquired at 3 months later following therapy.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China