Rranscranial Ultrasound Neuromuscular Electrical Stimulation Combined with Xing Nao Kai Qiao Acupuncture for Lower-limb Dysfunction in Hemiplegia after Cerebral Infarction: A Randomized Controlled Trial

Registration number:

ITMCTR2100005198

Date of Last Refreshed on:

2021-08-24

Date of Registration:

2021-08-24

Registration Status:

Prospective registration

Public title:

Rranscranial Ultrasound Neuromuscular Electrical Stimulation Combined with Xing Nao Kai Qiao Acupuncture for Lower-limb Dysfunction in Hemiplegia after Cerebral Infarction: A Randomized Controlled Trial

English Acronym:

Scientific title:

Rranscranial Ultrasound Neuromuscular Electrical Stimulation Combined with Xing Nao Kai Qiao Acupuncture for Lower-limb Dysfunction in Hemiplegia after Cerebral Infarction: A Randomized Controlled Trial

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100050256 ; ChiMCTR2100005198

Applicant:

Jin Yan

Study leader:

Jin Yan

Applicant telephone:

+86 15053999563

Study leader's telephone:

+86 15053999563

Applicant Fax:

Study leader's fax:

Applicant E-mail:

lyjy28@126.com

Study leader's E-mail:

lyjy28@126.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

27 Jiefang Road, Lanshan District, Linyi, Shandong

Study leader's address:

27 Jiefang Road, Lanshan District, Linyi, Shandong

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Linyi People's Hospital

Approved by ethic committee:

Approved No. of ethic committee:

Approved file of Ethical Committee:

Name of the ethic committee:

Date of approved by ethic committee:

2013/8/26 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Linyi People's Hospital

Primary sponsor's address:

27 Jiefang Road, Lanshan District, Linyi, Shandong

Secondary sponsor:

Country:

China

Province:

Shandong

City:

Linyi

Institution
hospital:

Linyi People's Hospital

Address:

27 Jiefang Road, Lanshan District

Source(s) of funding:

Self-financed

Target disease:

ischemic stroke

Target disease code:

Study type:

Interventional study

Study design:

Cross-sectional

Study phase:

Pilot clinical trial

Objectives of Study:

Observe the effect of transcranial ultrasound neuromuscular electrical stimulation combined with Xing Nao Kai Qiao acupuncture on the recovery of lower-limb dysfunction in hemiplegia after cerebral infarction.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1.The diagnostic criteria were stroke patients at the convalescent stage of the diagnosis and classification criteria for stroke formulated by the Fourth National Cerebrovascular Academic Conference in 1995 in China[2]; 2.For the first time, the diagnosis is confirmed by CT or MRI of the head; 3.Courses<3 months; 4.Clear consciousness, no dementia and cognitive dysfunction; 5.Stable condition and signed informed consent.

Exclusion criteria:

1.Patients with previous motor dysfunction; 2.Patients with knee joint, pelvic and sacroiliac joint disease that seriously affect the motor function of the limbs; 3.Patients with cerebral hemorrhage, brain injury, brain tumor, or combined with dysfunction of important organs such as heart, liver, kidney, lung; 4.Patients are in critical condition.

Study execute time:

From 2021-11-01

To      2022-12-01

Recruiting time:

From 2021-11-01

To      2022-12-01

Interventions:

54

Group:

Treatment group

Sample size:

Intervention:

Conventional medication + comprehensive rehabilitation training + Xingnao Kaiqiao acupuncture treatment + TUS-NMES treatment

Intervention code:

55

Group:

Control group

Sample size:

Intervention:

Conventional medication + comprehensive rehabilitation training + Xingnao Kaiqiao acupuncture treatment

Intervention code:

Total sample size : 109

Countries of recruitment
and research settings:

Country:

China

Province:

Shandong

City:

Linyi

Institution/hospital:

Linyi People's Hospital

Level of the institution:

Tertiary A

Outcomes:

Outcome:

The Fugl-Meyer Assessment scale

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

The modified Barthel Index (MBI)

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Equilibrium function

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

The Brunnstrom stage

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

none

Tissue:

Fate of sample 

Others

Note:

Not yet recruiting

Min age years
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

Random number table method.

Blinding:

IPD sharing:

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Contact us by email.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form, CRF.

Data Managemen Committee:

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above