Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy

NCT ID: NCT03921281

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

treatment group

The treatment group (n=38) will receive scalp acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks.

Group Type: EXPERIMENTAL

Rehabilitation Treatment

Intervention Type: OTHER

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.

scalp acupuncture treatment

Intervention Type: OTHER

The 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.

control group

The control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks.

Group Type: OTHER

Rehabilitation Treatment

Intervention Type: OTHER

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.

Interventions

Rehabilitation Treatment

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.

Intervention Type: OTHER

scalp acupuncture treatment

The 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. cerebral palsy patients between 12 and 72 months old

2. cerebral palsy was diagnosed according to the criteria of CP in international guidelines

3. children with CP of the spastic type

4. voluntary participation and informed consent signed

Exclusion Criteria

1. visual, auditory and mental disorders, affecting the rehabilitation assessment

2. the child with epilepsy who is not under control with medication

3. bleeding tendencies

4. being oversensitive to acupuncture

5. use of muscle relaxants or herbal therapies during the study period

6. participation in another clinical trial

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31907027 (View on PubMed)

Other Identifiers

CHFudanU-1

Identifier Type: -

Identifier Source: org_study_id