NCT02979743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

2.5 years

First QC Date

November 24, 2016

Last Update Submit

June 27, 2018

Conditions

Brain Injury, ChronicCerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Gross motor function measure and classification system (scores)

    Baseline

  • Gross motor function measure and classification system (scores)

    The 3rd month

Study Arms (2)

Occupational therapy group

PLACEBO COMPARATOR

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

Occupational therapy puls acupuncture and massage methods

ACTIVE COMPARATOR

The patients receive occupational therapy puls acupuncture and massage methods.

Behavioral: Occupational therapyOther: Occupational therapy puls acupuncture and massage methods

Interventions

Occupational therapyBEHAVIORAL
Occupational therapy groupOccupational therapy puls acupuncture and massage methods
Occupational therapy puls acupuncture and massage methodsOTHER
Occupational therapy puls acupuncture and massage methods

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31559169DERIVED

MeSH Terms

Conditions

Brain Injury, ChronicCerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Central Study Contacts

Jian Yang, Ph.D.,M.D.

CONTACT

+8618991232396cjr.yangjian@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 2, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)