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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03277534
Other study ID # 104-2314-B-010-024
Secondary ID
Status Completed
Phase N/A
First received September 5, 2017
Last updated September 6, 2017
Start date August 28, 2013
Est. completion date January 4, 2017

Study information

Verified date September 2017
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).


Description:

Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 4, 2017
Est. primary completion date January 4, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. first-ever cerebral cortical region involved chronic stroke, onset over a month,

2. able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and

3. at stable medical condition for intervention

Exclusion Criteria:

1. history of other neurological disorders,

2. cognitive impairment (Mini-Mental State Examination score <24, MMSE),26

3. unable to follow orders,

4. contraindications of ES, and

5. under 20 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electrical stimulation
sensory electrical stimulation was applied prior to upper limb functional training
Sham electrical stimulation
electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer Assessment for Upper Extremity evaluate changes in upper extremity function of the stroke subjects before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
Primary EEG-EMG coherence evaluate changes in functional connectivity between motor cortex and active muscles before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
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