Cerebral PalsyNCT03921281
Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy
A study testing scalp acupuncture treatment and Rehabilitation Treatment in people with Cerebral Palsy and Motor Dysfunction, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The investigators design a Multi-center randomized, control study to evaluate the therapeutic effect of the scalp acupuncture treatment for motor dysfunction in children with cerebral palsy by using the following outcomes: motor function, activity of daily living, quality of life. Read more about this study
- Who is it for?
- Ages 12 to 72 months
- Conditions the study is for
- Cerebral Palsy, Motor Dysfunction, Acupuncture
- What is being tested?
- scalp acupuncture treatment and Rehabilitation Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2022
- 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 12 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cerebral palsy patients between 12 and 72 months old
- cerebral palsy was diagnosed according to the criteria of CP in international guidelines
- children with CP of the spastic type
- voluntary participation and informed consent signed
Who cannot join
- visual, auditory and mental disorders, affecting the rehabilitation assessment
- the child with epilepsy who is not under control with medication
- bleeding tendencies
- being oversensitive to acupuncture
- use of muscle relaxants or herbal therapies during the study period
- participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy: Study Protocol for a Randomized Controlled Trial
The investigators design a Multi-center randomized, control study to evaluate the therapeutic effect of the scalp acupuncture treatment for motor dysfunction in children with cerebral palsy by using the following outcomes: motor function, activity of daily living, quality of life.
Read the detailed description
Cerebral palsy (CP) is a well-recognized neurodevelopmental condition beginning in early childhood and persisting throughout the lifetime. Motor disorders are often accompanied by disturbances of sensation, cognition, communication, perception, behavior, and seizures The activities of daily living and social participation are limited in children with CP due to motor dysfunction, this greatly influences the CP patient's quality of life, and return to society.
Western conventional treatment of CP is multi-professional rehabilitation. In China, CP rehabilitation mainly develops the clinical mode of combining traditional Chinese medicine and western medicine. Acupuncture use as a complementary or alternative therapy has increased worldwide and has become widely applied to CP rehabilitation, which confirms that the efficacy of acupuncture can have a great impact on CP management. Many studies have shown that scalp acupuncture has a remarkable treatment efficacy on motor dysfunction in children with CP in China. But, Although acupuncture as a treatment for cp has become widely accepted and showed better clinical curative effect than conventional treatments, a Meta-Analysis published in 2018 based on clinical randomized controlled trials summarized that the clinical curative effect of acupuncture treatment in children with CP remains uncertain due to the small number of randomized controlled trials available and the small sample sizes. More high-quality and large-scale studies are still needed. The purpose of this study is to observe the therapeutic effect of scalp acupuncture treatment for motor dysfunction in children with CP by using the international general evaluation scales.
In this 12-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 76 children with cerebral palsy will be recruited. The patients will be randomly assigned to two different groups: 1) the treatment group and 2) the control group. The treatment group (n=38) will receive scalp acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks, and the control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks. Both groups will be evaluated at baseline, week4 (treatment 12), week 8 (treatment 24), week12(treatment 36) and week 24(follow-up) using GMFM scale, FMFM scale, PEDI scale and CP-QOL scale. The study will be conducted at Children's Hospital of Fudan University.
- Conditions
- Cerebral Palsy, Motor Dysfunction, Acupuncture
- Being tested
- scalp acupuncture treatment, Rehabilitation Treatment
- Keywords
- Cerebral palsy, Motor dysfunction, Scalp acupuncture treatment, Safety/Efficacy assessment
- Medical subject headings
- Cerebral Palsy, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp acupuncture treatmentOther
The parameters for scalp acupuncture are set as follows:
- Scalp acupoint selection: The Motor Area of Jiao's Scalp acupuncture and Si shencong (EX-HN1).
- Acupuncture manipulation: Disposable stainless steel needles will be manually inserted in at an approximately 15-degree angle to a depth of 1.5-2.0 cm respectively along the upper point and middle point of the motor area on the scalp. The acupuncture direction of Si shencong (EX-HN1) acupoint is toward the Baihui (GV20) acupoint. the needles will be rotated for at least 200 revolutions per minute for 1 minute every 20 minutes for a total of 60 minutes.
- Treatment course: three times a week, 12 weeks in total.
Rehabilitation TreatmentOther
The children with CP will receive the conventional rehabilitation programs as mentioned above. The rehabilitation programs will be carried out three times a week (once every other day) for 12 weeks, and every time, the rehabilitation treatment (PT and OT) will last approximately for 1 hour. All rehabilitation treatments will be carried out by qualified therapists.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The treatment group (n=38) will receive scalp acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks. Receives: Other: scalp acupuncture treatment; Other: Rehabilitation Treatment |
| control group | Other | The control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks. Receives: Other: Rehabilitation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline GMFM at 4 weeks, 8 weeks and 12 weeks
The Gross Motor Function Measure (GMFM) is a standardized observational instrument designed to assess the gross motor function of children with CP. It is divided into five sections: Lying and Rolling, Sitting, Crawling and Kneeling, Standing, and Walking, Running and Jumping. Each item is on the basis of four levels: 0=does not initiate, 1=initiates, 2=partially completes, 3=completes or NT=not tested. The total score is a summation of the scores in the five areas by the Gross Motor Ability Estimator software (GMAE Version 1.0.)
Measured: The GMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Change from Baseline FMFM at 4 weeks, 8 weeks and 12 weeks
The Fine Motor Function Measure (FMFM) assessment scale is used to evaluate the fine motor activities of children with CP, including the upper limb activities and sensory ability. This scale includes five domains, namely audiovisual tracking ability(5 items), upper limb joint's ability(9 items), grasping ability(10 items), operation ability(13 items)and hand-eye coordination(24 items). Each item is on the basis of four levels: 0=does not initiate, 1=initiates, 2=partially completes, 3=completes. The total score(0～100 points) is a summation of the scores in the five areas.
Measured: The FMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Secondary outcomes (2)
Change from Baseline PEDI at 4 weeks, 8 weeks and 12 weeks
Pediatric Evaluation of Disability Inventory (PEDI) measures both functional performance and capability within three domains of (1) self-care, (2) mobility, and (3) social function in two categories, that is, the Functional Skills Scale (FSS), Caregiver Assistance Scale (CAS), and Modifications Scale. FSS covers 40 diverse content areas assessed using 197 items scored unable (0) or capable (1). The self-care domain comprises 73 items. The mobility domain has 59 items. The social function domain has 65 items. CAS It covers 20 diverse content areas assessed using 20 items scored on the following escalating 6-point scale: independent, supervision, minimal help, moderate help, maximum help, and total help. The items cover the self-care domain (n = 8), mobility domain (n = 7), and social function domain (n = 5). Modifications Scale measures any environmental or technical modifications needed to enhance the child's function.
Measured: PEDI will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Change from Baseline CPQOL at 4 weeks, 8 weeks and 12 weeks
The cerebral palsy quality of life questionnaire for children contains 66 items in seven domains: Social well-being and acceptance (SWB), Functioning (FUN), Participation and physical health (PART), Emotional well-being (EWB), Access to services (ACCESS), Pain and feeling about disability (PAIN), and Family health (FAMILY). Almost all of the items have the following item stem: 'How do you think your child feels about. . .' and a 9-point rating scale, where 1 = very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
Measured: CPQOL will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
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 Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Wang, Ph.D., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921281
- Sponsor's protocol ID
- CHFudanU-1
- Status last verified
- Oct 2022
- First submitted
- 13 Apr 2019
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because our data is managed by the clinical trial unit. We will respect the opinions of the clinical research unit management committee and the subjects, which will ultimately decide whether to share the study data with other researchers.
Publications
Wang J, Shi W, Khiati D, Shi B, Shi X, Luo D, Wang Y, Deng R, Huang H, Li J, Yan W, Yang H. Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jan 6;21(1):29. doi: 10.1186/s13063-019-3986-z.
PubMed 31907027
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03921281
- Acronym / sponsor ID
- CHFudanU-1
- Conditions
- Cerebral Palsy, Motor Dysfunction, Acupuncture
- Keywords
- Cerebral palsy, Motor dysfunction, Scalp acupuncture treatment, Safety/Efficacy assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Apr 2019 (actual)
- 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 investigators design a Multi-center randomized, control study to evaluate the therapeutic effect of the scalp acupuncture treatment for motor dysfunction in children with cerebral palsy by using the following outcomes: motor function, activity of daily living, quality of life.
Detailed description
Cerebral palsy (CP) is a well-recognized neurodevelopmental condition beginning in early childhood and persisting throughout the lifetime. Motor disorders are often accompanied by disturbances of sensation, cognition, communication, perception, behavior, and seizures The activities of daily living and social participation are limited in children with CP due to motor dysfunction, this greatly influences the CP patient's quality of life, and return to society.
Western conventional treatment of CP is multi-professional rehabilitation. In China, CP rehabilitation mainly develops the clinical mode of combining traditional Chinese medicine and western medicine. Acupuncture use as a complementary or alternative therapy has increased worldwide and has become widely applied to CP rehabilitation, which confirms that the efficacy of acupuncture can have a great impact on CP management. Many studies have shown that scalp acupuncture has a remarkable treatment efficacy on motor dysfunction in children with CP in China. But, Although acupuncture as a treatment for cp has become widely accepted and showed better clinical curative effect than conventional treatments, a Meta-Analysis published in 2018 based on clinical randomized controlled trials summarized that the clinical curative effect of acupuncture treatment in children with CP remains uncertain due to the small number of randomized controlled trials available and the small sample sizes. More high-quality and large-scale studies are still needed. The purpose of this study is to observe the therapeutic effect of scalp acupuncture treatment for motor dysfunction in children with CP by using the international general evaluation scales.
In this 12-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 76 children with cerebral palsy will be recruited. The patients will be randomly assigned to two different groups: 1) the treatment group and 2) the control group. The treatment group (n=38) will receive scalp acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks, and the control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks. Both groups will be evaluated at baseline, week4 (treatment 12), week 8 (treatment 24), week12(treatment 36) and week 24(follow-up) using GMFM scale, FMFM scale, PEDI scale and CP-QOL scale. The study will be conducted at Children's Hospital of Fudan University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: scalp acupuncture treatment, Other: Rehabilitation TreatmentThe treatment group (n=38) will receive scalp acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks. |
| control group | Other | Other: Rehabilitation TreatmentThe control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks. |
Who may qualify
- Ages
- 12 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- cerebral palsy patients between 12 and 72 months old
- cerebral palsy was diagnosed according to the criteria of CP in international guidelines
- children with CP of the spastic type
- voluntary participation and informed consent signed
Key exclusion criteria (6 listed)
- visual, auditory and mental disorders, affecting the rehabilitation assessment
- the child with epilepsy who is not under control with medication
- bleeding tendencies
- being oversensitive to acupuncture
- use of muscle relaxants or herbal therapies during the study period
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 |
|---|---|---|
| scalp acupuncture treatmentThe parameters for scalp acupuncture are set as follows: 1. Scalp acupoint selection: The Motor Area of Jiao's Scalp acupuncture and Si shencong (EX-HN1). 2. Acupuncture manipulation: Disposable stainless steel needles will be manually inserted in at an approximately 15-degree angle to a depth of 1.5-2.0 cm respectively along the upper point and middle point of the motor area on the scalp. The acupuncture direction of Si shencong (EX-HN1) acupoint is toward the Baihui (GV20) acupoint. the needles will be rotated for at least 200 revolutions per minute for 1 minute every 20 minutes for a total of 60 minutes. 3. Treatment course: three times a week, 12 weeks in total. | Other | treatment group |
| Rehabilitation TreatmentThe children with CP will receive the conventional rehabilitation programs as mentioned above. The rehabilitation programs will be carried out three times a week (once every other day) for 12 weeks, and every time, the rehabilitation treatment (PT and OT) will last approximately for 1 hour. All rehabilitation treatments will be carried out by qualified therapists. | Other | control group, treatment group |
Primary outcome
Change from Baseline GMFM at 4 weeks, 8 weeks and 12 weeks
Time frame: The GMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
The Gross Motor Function Measure (GMFM) is a standardized observational instrument designed to assess the gross motor function of children with CP. It is divided into five sections: Lying and Rolling, Sitting, Crawling and Kneeling, Standing, and Walking, Running and Jumping. Each item is on the basis of four levels: 0=does not initiate, 1=initiates, 2=partially completes, 3=completes or NT=not tested. The total score is a summation of the scores in the five areas by the Gross Motor Ability Estimator software (GMAE Version 1.0.)
Change from Baseline FMFM at 4 weeks, 8 weeks and 12 weeks
Time frame: The FMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
The Fine Motor Function Measure (FMFM) assessment scale is used to evaluate the fine motor activities of children with CP, including the upper limb activities and sensory ability. This scale includes five domains, namely audiovisual tracking ability(5 items), upper limb joint's ability(9 items), grasping ability(10 items), operation ability(13 items)and hand-eye coordination(24 items). Each item is on the basis of four levels: 0=does not initiate, 1=initiates, 2=partially completes, 3=completes. The total score(0～100 points) is a summation of the scores in the five areas.
2 secondary outcomes
Change from Baseline PEDI at 4 weeks, 8 weeks and 12 weeks
Time frame: PEDI will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Change from Baseline CPQOL at 4 weeks, 8 weeks and 12 weeks
Time frame: CPQOL will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 31907027Wang J, Shi W, Khiati D, Shi B, Shi X, Luo D, Wang Y, Deng R, Huang H, Li J, Yan W, Yang H. Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jan 6;21(1):29. doi: 10.1186/s13063-019-3986-z.
- Individual participant dataSharing planned: No. Because our data is managed by the clinical trial unit. We will respect the opinions of the clinical research unit management committee and the subjects, which will ultimately decide whether to share the study data with other researchers.
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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.
Jun Wang, Ph.D. principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scalp acupuncture treatment and Rehabilitation Treatment in people with Cerebral Palsy and Motor Dysfunction, run by Children's Hospital of Fudan 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline GMFM at 4 weeks, 8 weeks and 12 weeks (time frame: The GMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).). 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 NCT03921281, 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 28 Feb 2023.