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Status unknownNCT02979743Updated Jun 29, 2018

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

An interventional study of Occupational therapy and Occupational therapy puls acupuncture and massage methods in Brain Injury, Chronic and Cerebral Palsy, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-06-29.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Brain Injury, Chronic
  • Cerebral Palsy
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 50 is close to the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 3-18 years
  • Spastic cerebral palsy
  • The complete clinical and MRI data

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralOccupational therapy
  • OtherOccupational therapy puls acupuncture and massage methods
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What researchers measure

Primary outcomes

  1. Fine motor function measure (scores)

    It is acquired at baseline.

    Time frame: Baseline

  2. Fine motor function measure (scores)

    It is acquired at 3 months later following therapy.

    Time frame: The 3rd month

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. Gross motor function measure and classification system (scores)

    It is acquired at 3 months later following therapy.

    Time frame: The 3rd month

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Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 31559169 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02979743
Lead 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
Responsible party
Sponsor
First posted
Dec 2, 2016
Start date
Dec 2016
Primary completion
Jun 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jun 29, 2018

Study contacts

Jian Yang, Ph.D.,M.D.
Contact
cjr.yangjian@vip.163.com
+8618991232396

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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