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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Injury, Chronic, Cerebral Palsy

Intervention / Treatment
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* Behavioral: Occupational therapy
* Other: Occupational therapy puls acupuncture and massage methods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |