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

MRI-based Neuroimaging Predictors of Clinical Improvements Following Occupational Therapy (OT) or OT Puls Acupuncture and Massage Methods in Children With Cerebral Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Brain Injury, Chronic
• Intervention / Treatment: Behavioral: Occupational therapy; Other: Occupational therapy puls acupuncture and massage methods

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Jian Yang, Ph.D.,M.D.; Phone Number: +8618991232396; Email: cjr.yangjian@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Occupational therapy group; 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.	Behavioral: Occupational therapy
Active Comparator: Occupational therapy puls acupuncture and massage methods; The patients receive occupational therapy puls acupuncture and massage methods.	Behavioral: Occupational therapy; Other: Occupational therapy puls acupuncture and massage methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fine motor function measure (scores)	It is acquired at baseline.	Baseline
Fine motor function measure (scores)	It is acquired at 3 months later following therapy.	The 3rd month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross motor function measure and classification system (scores)	It is acquired at baseline.The system is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.	Baseline
Gross motor function measure and classification system (scores)	It is acquired at 3 months later following therapy.	The 3rd month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Xijing Hospital; Children's Hospital of Fudan University; Shaanxi Provincial People's Hospital; Second Affiliated Hospital of Wenzhou Medical University; General Hospital of Ningxia Medical University; Baoji Central Hospital; Shenzhen Children's Hospital; Hainan People's Hospital; Zunyi Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries; Brain Injury, Chronic
• Other Study ID Numbers: 2016YFC0100300CP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No