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

Primary Purpose

Brain Injury, Chronic, Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Occupational therapy
Occupational therapy puls acupuncture and massage methods
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Injury, Chronic

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Occupational therapy group

Occupational therapy puls acupuncture and massage methods

Arm Description

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.

The patients receive occupational therapy puls acupuncture and massage methods.

Outcomes

Primary Outcome Measures

Fine motor function measure (scores)
It is acquired at baseline.
Fine motor function measure (scores)
It is acquired at 3 months later following therapy.

Secondary Outcome Measures

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.
Gross motor function measure and classification system (scores)
It is acquired at 3 months later following therapy.

Full Information

First Posted
November 24, 2016
Last Updated
June 27, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Shenzhen Children's Hospital, General Hospital of Ningxia Medical University, Xijing Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Children's Hospital of Fudan University, Hainan People's Hospital, Zunyi Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02979743
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Shenzhen Children's Hospital, General Hospital of Ningxia Medical University, Xijing Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Children's Hospital of Fudan University, Hainan People's Hospital, Zunyi Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Chronic, Cerebral Palsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Occupational therapy group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Occupational therapy puls acupuncture and massage methods
Arm Type
Active Comparator
Arm Description
The patients receive occupational therapy puls acupuncture and massage methods.
Intervention Type
Behavioral
Intervention Name(s)
Occupational therapy
Intervention Type
Other
Intervention Name(s)
Occupational therapy puls acupuncture and massage methods
Primary Outcome Measure Information:
Title
Fine motor function measure (scores)
Description
It is acquired at baseline.
Time Frame
Baseline
Title
Fine motor function measure (scores)
Description
It is acquired at 3 months later following therapy.
Time Frame
The 3rd month
Secondary Outcome Measure Information:
Title
Gross motor function measure and classification system (scores)
Description
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.
Time Frame
Baseline
Title
Gross motor function measure and classification system (scores)
Description
It is acquired at 3 months later following therapy.
Time Frame
The 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Yang, Ph.D.,M.D.
Phone
+8618991232396
Email
cjr.yangjian@vip.163.com
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yang, Ph.D.,M.D.
Phone
+8618991232396
Email
cjr.yangjian@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31559169
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.
Results Reference
derived

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

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