Brain Injury, ChronicNCT02979743
MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy
A study testing Occupational therapy and Occupational therapy puls acupuncture and massage methods in people with Brain Injury, Chronic and Cerebral Palsy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Brain Injury, Chronic, Cerebral Palsy
- What is being tested?
- Occupational therapy and Occupational therapy puls acupuncture and massage methods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 3-18 years
- Spastic cerebral palsy
- The complete clinical and MRI data
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Jian Yang, Ph.D.,M.D., +8618991232396, cjr.yangjian@vip.163.com
About this study
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
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.
- Conditions
- Brain Injury, Chronic, Cerebral Palsy
- Being tested
- Occupational therapy, Occupational therapy puls acupuncture and massage methods
- Medical subject headings
- Brain Injury, Chronic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyBehavioural
Occupational therapy puls acupuncture and massage methodsOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Occupational therapy |
| Occupational therapy puls acupuncture and massage methods | Active comparator | The patients receive occupational therapy puls acupuncture and massage methods. Receives: Behavioral: Occupational therapy; Other: Occupational therapy puls acupuncture and massage methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine motor function measure (scores)
It is acquired at baseline.
Measured: Baseline
Fine motor function measure (scores)
It is acquired at 3 months later following therapy.
Measured: The 3rd month
Secondary outcomes (2)
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.
Measured: Baseline
Gross motor function measure and classification system (scores)
It is acquired at 3 months later following therapy.
Measured: The 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injury, ChronicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979743
- Sponsor's protocol ID
- 2016YFC0100300CP01
- Status last verified
- Jun 2018
- First submitted
- 24 Nov 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02979743
- Acronym / sponsor ID
- 2016YFC0100300CP01
- Conditions
- Brain Injury, Chronic, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- 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
- Study start
- Dec 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy group | Placebo comparator | Behavioral: Occupational therapyThe 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. |
| Occupational therapy puls acupuncture and massage methods | Active comparator | Behavioral: Occupational therapy, Other: Occupational therapy puls acupuncture and massage methodsThe patients receive occupational therapy puls acupuncture and massage methods. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 3-18 years
- Spastic cerebral palsy
- The complete clinical and MRI data
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational therapy | Behavioural | Occupational therapy group, Occupational therapy puls acupuncture and massage methods |
| Occupational therapy puls acupuncture and massage methods | Other | Occupational therapy puls acupuncture and massage methods |
Primary outcome
Fine motor function measure (scores)
Time frame: Baseline
It is acquired at baseline.
Fine motor function measure (scores)
Time frame: The 3rd month
It is acquired at 3 months later following therapy.
2 secondary outcomes
Gross motor function measure and classification system (scores)
Time frame: Baseline
Gross motor function measure and classification system (scores)
Time frame: The 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 31559169Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy and Occupational therapy puls acupuncture and massage methods in people with Brain Injury, Chronic and Cerebral Palsy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Yang, Ph.D.,M.D. (+8618991232396, cjr.yangjian@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fine motor function measure (scores) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.