NCT01806233

Brief Summary

There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

8.8 years

First QC Date

February 26, 2013

Last Update Submit

August 10, 2021

Conditions

Ischemic StrokeParalysis

Outcome Measures

Primary Outcomes (1)

  • Simplified Fugl-Meyer Scale

    5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks

    8 weeks

Secondary Outcomes (2)

  • Burden of Stroke Scale-Boss

    6 months

  • Modified Barthel Index

    6 months

Study Arms (2)

Acupuncture

EXPERIMENTAL

acupuncture

Procedure: Acupuncture

Rehabilitation

EXPERIMENTAL

rehabilitation exercise

Procedure: Rehabilitation

Interventions

AcupuncturePROCEDURE

The treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total.

Acupuncture
RehabilitationPROCEDURE

The matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all.

Also known as: Rehabilitation treatment
Rehabilitation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The ages of stroke patients from 40 years old to 70 years old.
  • The principle diagnosis according to \<diagnosis-treatment criteria of stroke(trial implementation)\>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.
  • Recent stroke from 7 days to 6 months after onset.
  • Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS\>8.
  • Written informed consent by inpatient.

You may not qualify if:

  • Stroke with conscious disturbance or serious cognitive impairment.
  • Stroke with limb spasm；ASHWORTH≥1.
  • Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.
  • Being oversensitive to electrical stimulus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital,Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

RECRUITING

Related Publications (1)

  • Xu J, Pei J, Fu QH, Zhan YJ. The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study. Evid Based Complement Alternat Med. 2020 Jul 15;2020:1520851. doi: 10.1155/2020/1520851. eCollection 2020.

    PMID: 32733577DERIVED

MeSH Terms

Conditions

Ischemic StrokeParalysis

Interventions

Acupuncture TherapyRehabilitation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jian Pei, MD

    Shanghai University of Traditional Chinese Medicine

    STUDY CHAIR

  • Yi Wu, MD

    Huashan Hospital

    STUDY CHAIR

  • Jie Jia, MD

    Huashan Hospital

    STUDY DIRECTOR

  • Yi Song, MM

    Shanghai University of Traditional Chinese Medicine

    STUDY DIRECTOR

  • Zouqin Huang, MM

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Xiaoxin You, MM

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Qinhui FU, MD

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Jun Wang, MM

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Pei, MD

CONTACT

021-64385700jianpei99@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 7, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)