|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-ICR-15007022 |
|
Date of registration:
|
2015-09-06 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A research of biomechanic stimulation and healing of hemiplegia gait
|
|
Scientific title:
|
A research of biomechanic stimulation and healing of hemiplegia gait |
|
Date of first enrolment:
|
2014-05-01 |
|
Target sample size:
|
botulinum toxin A type group:30;conventional treatment A group :30;Dynamic electrical stimulation treatment group:30;conventional treatment B group :30;blank control group:30;validation group :30; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=11821 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
New Treatment Measure Clinical Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Jing-guang QIAN
|
|
Address:
|
8 Linggusi Road, Xuanwu District, Nanjing, Jiangsu, China
|
|
Telephone:
|
+86 025-84755172 |
|
Email:
|
2867996025@qq.com |
|
Affiliation:
|
|
|
|
Name:
|
He-sheng SONG
|
|
Address:
|
8 Linggusi Road, Xuanwu District, Nanjing, Jiangsu, China
|
|
Telephone:
|
+86 18985193417 |
|
Email:
|
songhesheng111@163.com |
|
Affiliation:
|
Guizhou Normal University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patient selection will be based on key points of cerebrovascular disease diagnosis, which were enacted by the Chinese Medical Association in 1995:
1. Men or women, with diagnostic criteria of definite stroke based on computed tomography (CT) or magnetic resonance imaging (MRI);
2. Initial cerebral infarction or initial cerebral hemorrhage;
3. Equinus deformity (i.e.Excessive plantar flexion of the ankle);
4. Aged between 40 to 70 years;
5. MAS score >=2 [29];
6. The patients can walk at least 5m without any aid;
7. Without cognition and speech disorder;
8. Signed informed consent.
Exclusion criteria: The patients with any of following conditions will be excluded:
1. The stroke was caused by brain injury;
2. With pacemaker installation, heart stents, or heart bypass operation;
3. Exercise-induced or uncontrolled angina within three months, or severe dyspnea at rest;
4. Other illnesses, judged by the patient or study physician to make participation in this study inadvisable;
5. Bilateral total hip or knee arthroplasties;
6. Obesity (i.e., body mass index>30kg/m2).
Age minimum:
40
Age maximum:
70
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
stroke
|
|
Intervention(s)
|
|
botulinum toxin A type group:inject botulinum toxin A type;conventional treatment A group :conventional treatment;Dynamic electrical stimulation treatment group:Dynamic electrical stimulation;conventional treatment B group :conventional treatment;blank control group:null;validation group :botulinum toxin A type ;
|
|
Primary Outcome(s)
|
|
modified Ashworth Scale;Brunnstrom Scale;modified Barthel index;botulinum toxin dose;three-dimensional functional biomechanics;spatiotemporal gait variables;muscle force;joint torque;functional magnetic resonance imaging;
|
|
Secondary Outcome(s)
|
|
Electrical stimulation of voltage;Electrical stimulation frequency;Electrical stimulation of time;fMRI block time;
|
|
Source(s) of Monetary Support
|
|
National Natural Science Foundation of China
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|