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

Xi'an Jiaotong University

Status: Unknown

Conditions: Brain Injury, Chronic; Cerebral Palsy

Treatments: Behavioral: Occupational therapy; Other: Occupational therapy puls acupuncture and massage methods

Study type: Interventional

Funder types: Other

Identifiers

NCT02979743

2016YFC0100300CP01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Occupational therapy group

Placebo Comparator group

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.

Treatment:

Behavioral: Occupational therapy

Occupational therapy puls acupuncture and massage methods

Active Comparator group

Description:

The patients receive occupational therapy puls acupuncture and massage methods.

Treatment:

Other: Occupational therapy puls acupuncture and massage methods

Behavioral: Occupational therapy