NCT02871453

Brief Summary

The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.

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
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5.7 years

First QC Date

July 17, 2016

Last Update Submit

February 4, 2020

Conditions

Ischemic StrokeHemiplegia

Keywords

Ischemic StrokeMotor DysfunctionScalp Acupuncture

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline FMA at 4 weeks, 8 weeks

    The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points

    The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).

Secondary Outcomes (3)

  • Change from Baseline MBI at 4 weeks, 8 weeks

    The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).

  • Change from Baseline SS-QOL at 4 weeks, 8 weeks

    The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).

  • Change from Baseline SSTCM at 4 weeks, 8 weeks

    The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).

Study Arms (2)

Acupuncture combined rehabilitation

EXPERIMENTAL

Scalp acupuncture treatment Rehabilitation treatment

Device: Scalp Acupuncture Treatment

Rehabilitation

EXPERIMENTAL

Rehabilitation treatment

Other: Rehabilitation treatment

Interventions

Scalp Acupuncture TreatmentDEVICE

The Motor Area of the scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total.

Also known as: Acupuncture
Acupuncture combined rehabilitation
Rehabilitation treatmentOTHER

The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists.

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
  • Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
  • Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
  • Recent stroke from 1 month to 6 months after onset
  • Stroke with limb motor dysfunction
  • Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score \> 24
  • Voluntary participation and informed consent signed.

You may not qualify if:

  • Stroke with conscious disturbance or serious cognitive impairment
  • Presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
  • Impaired hepatic or renal function
  • bleeding tendency
  • Being oversensitive to acupuncture
  • participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Wang J, Pei J, Khiati D, Fu Q, Cui X, Song Y, Yan M, Shi L, Cai Y, Ma Y. Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial. Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.

    PMID: 28633675DERIVED

MeSH Terms

Conditions

Ischemic StrokeHemiplegiaNeurologic Manifestations

Interventions

Acupuncture TherapyRehabilitation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisSigns 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

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

July 17, 2016

First Posted

August 18, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)