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

NCT03921281 | Completed DMC

• 1 other identifier: CHFudanU-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Motor Dysfunction; Acupuncture

Keywords

Cerebral palsy; Motor dysfunction; Scalp acupuncture treatment; Safety/Efficacy assessment

Outcome Measures

Primary Outcomes (2)

• 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.)

  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.

  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

  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

  CPQOL will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).

Study Arms (2)

treatment group

EXPERIMENTAL

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

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.

Other: Rehabilitation Treatment

Interventions

scalp acupuncture treatment 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.

treatment group

Rehabilitation Treatment 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.

control group; treatment group

Eligibility Criteria

• Age: 12 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• 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.

  PMID: 31907027 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Neurologic Manifestations

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jun Wang, Ph.D.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 19, 2019
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)