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Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke

Primary Purpose

Brain Ischemia, Hemiplegic Patients With Stroke, Image Science

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abdominal acupuncture
Sham abdominal acupuncture
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Ischemia focused on measuring Functional magnetic resonance imaging（fMRI）, Surface electromyography （sEMG）, Abdominal acupuncture, Brain Plasticity, Effects and mechanism

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
  2. Age 35 to 75 years old;
  3. Course of disease 0.5 to 3 months with stable vital signs;
  4. No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
  5. Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
  6. Agree to sign the informed consent;
  7. Unilateral neglect.

Exclusion Criteria:

  1. Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
  2. Contraindication to undergo a 3T MR imaging;
  3. Claustrophobia;
  4. Have severe heart, hepatic or renal failure;
  5. Don' t cooperate with the treatment;
  6. Have participated in other clinical trails recently.

Sites / Locations

  • Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting
  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Treatment Group A

Treatment Group B

Control Group

Arm Description

Abdominal acupuncture and upper limb rehabilitation training

Sham abdominal acupuncture and upper limb rehabilitation training

Upper limb rehabilitation only

Outcomes

Primary Outcome Measures

The integrity of the corticospinal tract
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Motor function of muscles
Common measures of sEMG will be tested. See the study protocol for details.

Secondary Outcome Measures

Wolf Motor Function Test
See the study protocol for details
Brunnstrom staging of upper limb movement
See the study protocol for details
Fugl-Meyer Motor Assessment of upper limb
See the study protocol for details
Modified Barthel Index，MBI
See the study protocol for details

Full Information

First Posted
July 7, 2018
Last Updated
July 7, 2019
Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03712085
Brief Title
Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
Official Title
Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia, Hemiplegic Patients With Stroke, Image Science, Electrophysiology of Neuromuscular, Abdominal Acupuncture
Keywords
Functional magnetic resonance imaging（fMRI）, Surface electromyography （sEMG）, Abdominal acupuncture, Brain Plasticity, Effects and mechanism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A
Arm Type
Active Comparator
Arm Description
Abdominal acupuncture and upper limb rehabilitation training
Arm Title
Treatment Group B
Arm Type
Sham Comparator
Arm Description
Sham abdominal acupuncture and upper limb rehabilitation training
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Upper limb rehabilitation only
Intervention Type
Other
Intervention Name(s)
Abdominal acupuncture
Intervention Description
Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Sham abdominal acupuncture
Other Intervention Name(s)
Upper limb rehabilitation training
Intervention Description
Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min.
Primary Outcome Measure Information:
Title
The integrity of the corticospinal tract
Description
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Time Frame
Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
Title
Motor function of muscles
Description
Common measures of sEMG will be tested. See the study protocol for details.
Time Frame
SEMG will be tested before and after 4 weeks treatment,twice totally.
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
See the study protocol for details
Time Frame
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Title
Brunnstrom staging of upper limb movement
Description
See the study protocol for details
Time Frame
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Title
Fugl-Meyer Motor Assessment of upper limb
Description
See the study protocol for details
Time Frame
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Title
Modified Barthel Index，MBI
Description
See the study protocol for details
Time Frame
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI; Age 35 to 75 years old; Course of disease 0.5 to 3 months with stable vital signs; No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ; Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point; Agree to sign the informed consent; Unilateral neglect. Exclusion Criteria: Recurrent stroke，subarachnoid hemorrhage, brain tumors patients; Contraindication to undergo a 3T MR imaging; Claustrophobia; Have severe heart, hepatic or renal failure; Don' t cooperate with the treatment; Have participated in other clinical trails recently.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxia Chen, Master
Phone
020-39318381
Ext
+8613609031028
Email
chx2004@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihuan Pan, Doctor
Phone
020-39318381
Ext
+8613763334058
Email
panruihuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxia Chen, Master
Organizational Affiliation
Director of the rehabilitation department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincet Chi-kwan Cheung, Doctor
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia P Chen, Master
Phone
020-81887233
Ext
02039318381
Email
chx2004@126.com
First Name & Middle Initial & Last Name & Degree
Ruihuan P Pan, Doctor
Phone
020-81887233
Ext
02081887233
Email
panruihuan@163.com
First Name & Middle Initial & Last Name & Degree
Hongxia P Chen, Master
First Name & Middle Initial & Last Name & Degree
Vincet Chi-kwan P Cheung, Doctor
First Name & Middle Initial & Last Name & Degree
Ruihuan P Pan, Doctor
First Name & Middle Initial & Last Name & Degree
Bo Liu, Master
First Name & Middle Initial & Last Name & Degree
Youhua Guo, Master
First Name & Middle Initial & Last Name & Degree
Zhijing Yang, Master
First Name & Middle Initial & Last Name & Degree
Lechang Zhan, Master
First Name & Middle Initial & Last Name & Degree
Mingfeng He, Master
First Name & Middle Initial & Last Name & Degree
Chunxing Duan, Master
First Name & Middle Initial & Last Name & Degree
Shanshan Ling, Postgraduate
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Chi-Kwan Cheung, Doctor
Phone
(852)59270597
Email
vckc@cuhk.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke

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