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Featured TCM rehabilitation related diagnosis and treatment techniques - A study on the treatment of lower limb dysfunction after stroke by Daoyin TCM and lower limb robot technology

Registration number：

ITMCTR2023000038

Date of Last Refreshed on：

2023-08-30

Date of Registration：

2023-08-30

Registration Status：

Retrospective registration

Public title：

Featured TCM rehabilitation related diagnosis and treatment techniques - A study on the treatment of lower limb dysfunction after stroke by Daoyin TCM and lower limb robot technology

English Acronym：

Scientific title：

TCM rehabilitation medicine

Scientific title acronym：

Study subject ID：

ZZ10-015

The registration number of the Partner Registry or other register：

Applicant：

Haolin Tian

Study leader：

Yuanbin Yang

Applicant telephone：

17801168295

Study leader's telephone：

18210897538

Applicant Fax：

Study leader's fax：

Applicant E-mail：

tianhl216@163.com

Study leader's E-mail：

duyiran0506@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Wangjing Hospital of China Academy of Chinese Medical Sciences, 6 Zhonghuan South Road, Chaoyang District, Beijing

Study leader's address：

Wangjing Hospital of China Academy of Chinese Medical Sciences, 6 Zhonghuan South Road, Chaoyang District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Wangjing Hospital of China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

WJEC-KT-2017-016-P001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Wangjing Hospital of China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2018/2/28 0:00:00

Contact Name of the ethic committee：

Hao Wang

Contact Address of the ethic committee：

Wangjing Hospital of China Academy of Chinese Medical Sciences, Huajiadi Street, Chaoyang District, Beijing

Contact phone of the ethic committee：

010-84739681

Contact email of the ethic committee：

wjyyec@126.com

Primary sponsor：

Wangjing Hospital of China Academy of Chinese Medical Sciences

Primary sponsor's address：

Wangjing Hospital of China Academy of Chinese Medical Sciences

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Wangjing Hospital, China Academy of Chinese Medical Sciences

Address：

Wangjing Hospital, China Academy of Chinese Medical Sciences, No. 6 Zhonghuan South Road, Chaoyang District, Beijing

Source(s) of funding：

China Academy of Chinese Medical Sciences

Target disease：

Stroke

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To study a new model of rehabilitation training for lower limb dysfunction after stroke.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Refer to the Diagnostic Key Points of Various Cerebrovascular Diseases revised by the Fourth National Conference on Cerebrovascular Diseases of the Chinese Medical Association in 1995, which meets the diagnostic criteria of cerebral hemorrhage and cerebral infarction; 2. Aged between 25 and 75; 3. The course of the disease is between 2 weeks and 6 months after stroke, and the condition is stable, able to tolerate rehabilitation and other treatments; 4. The patient had lower limb dysfunction caused by stroke, with spasticity < grade 2 (modified Ashworth scale); 5.MMSE＞24分 6. Patients who voluntarily participate in this clinical trial and sign informed consent.

Exclusion criteria：

1. Patients with hemiplegia caused by non-cerebrovascular diseases such as brain trauma, brain tumor and craniocerebral surgery; 2. Patients with cerebral infarction complicated with cerebral hemorrhage; 3. Patients with severe heart, lung, liver, kidney and other organ failure; 4. Patients with severe aphasia, severe auditory comprehension and cognitive dysfunction who cannot communicate; 5. Patients with a history of stroke and/or residual limb dysfunction; 6. In addition to stroke, there are other factors causing lower limb paralysis, such as Guillain-Barre syndrome, multiple sclerosis, myasthenia gravis, etc. 7. Poor compliance, not according to the doctor's advice for treatment; 8. Those who have received systematic rehabilitation treatment in the past.

Study execute time：

From 2017-01-01

To      2019-12-31

Recruiting time：

From 2018-03-01

To      2019-12-11

Interventions：

20

Group：

Daoyin and Lower limb robot group

Sample size：

Intervention：

TCM Daoyin and lower limb robot

Intervention code：

20

Group：

Daoyin group

Sample size：

Intervention：

TCM Daoyin

Intervention code：

20

Group：

Control group

Sample size：

Intervention：

no

Intervention code：

20

Group：

Lower limb robot group

Sample size：

Intervention：

Lower limb robot

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Beijing

Institution/hospital：

Wangjing Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

third-grade class-A hospital

Outcomes：

Outcome：

Berg

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Barthel index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fugl-Meyer Motor Function Rating Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

surface myoelectricity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

10m maximum walking speed

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Completed

25
Min age years
75
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

Blinding：

Due to the specificity of the subject, the intervention methods used are robot and Daoyin, so the single-blind method, blind evaluator and statistical analyst are used.

IPD sharing：

Yes

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

Chinese Clinical Trial Registry(http://www.medresman.org.cn)

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

CRF table

Data Managemen Committee：

Yes

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

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