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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979743
• Other study ID #: 2016YFC0100300CP01
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jian Yang, Ph.D.,M.D.
• Phone: +8618991232396
• Email: cjr.yangjian[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Cerebral Palsy

Intervention

Behavioral:
• Occupational therapy

Other:
• Occupational therapy puls acupuncture and massage methods

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fine motor function measure (scores)	It is acquired at baseline.	Baseline
Primary	Fine motor function measure (scores)	It is acquired at 3 months later following therapy.	The 3rd month
Secondary	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
Secondary	Gross motor function measure and classification system (scores)	It is acquired at 3 months later following therapy.	The 3rd month