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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02011854
Other study ID # PW2013A-41
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 10, 2013
Last updated December 12, 2013
Start date October 2013
Est. completion date October 2016

Study information

Verified date December 2013
Source Shanghai University of Traditional Chinese Medicine
Contact huang Zouqin, Dr.
Phone 021-58989669/2727
Email hzqmusic@yeah.net
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Shoulder-hand syndrome,a common complication of stroke patient,which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or ? period.

Exclusion Criteria:

- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome ? period,Serious primary diseases such as heart,liver and kidney,Mental illness.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Device:
rehabilitation
rehabilitation,To treat five times a week,Total course is eight weeks
Acupuncture


Locations

Country Name City State
China Pudong New Area TCM Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Zouqin Huang Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Barthel index (BI) To evaluate patient's ability in daily life 4 weeks and 8 weeks after treatment Yes
Primary Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS) To evaluate the pain in shoulder joint 4 weeks and 8 weeks after treatment Yes
Secondary Fugl-Meyer scale To evaluate the limb movement function 4 weeks and 8 weeks after treatment Yes