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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02979743

Collaborator

Shenzhen Children's Hospital (Other), General Hospital of Ningxia Medical University (Other), Xijing Hospital (Other), Second Affiliated Hospital of Wenzhou Medical University (Other), Shaanxi Provincial People's Hospital (Other), Baoji Central Hospital (Other), Children's Hospital of Fudan University (Other), Hainan People's Hospital (Other), Zunyi Medical College (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injury, Chronic Cerebral Palsy	Behavioral: Occupational therapy Other: Occupational therapy puls acupuncture and massage methods	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

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 Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fine motor function measure (scores) [Baseline]
It is acquired at baseline.
Fine motor function measure (scores) [The 3rd month]
It is acquired at 3 months later following therapy.

Secondary Outcome Measures

Gross motor function measure and classification system (scores) [Baseline]
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) [The 3rd month]
It is acquired at 3 months later following therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT02979743

Other Study ID Numbers:

2016YFC0100300CP01

First Posted:

Dec 2, 2016

Last Update Posted:

Jun 29, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Brain Injuries

Cerebral Palsy

Brain Injury, Chronic

Study Results

No Results Posted as of Jun 29, 2018