NCT02085642

Brief Summary

The purpose of this study is to investigate if acupuncture is more effective than sham treatment in reducing lower extremity spasticity, and improving gait speed in the chronic phase of stroke recovery.

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
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable stroke

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 19, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

February 19, 2014

Last Update Submit

August 22, 2016

Conditions

Stroke

Keywords

StrokeAcupunctureGaitSpasticity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 2 minute walk test

    Two-minute walk tests (2MWT) - Participants are required to walk continuously for 2 minutes, using their regular aids or orthoses, but with no manual support. The walk will take place over a distance of 10m, and participants will be required to change direction of their own accord. The distance walked in a 2-minute interval will be recorded

    Baseline to 3 weeks

Secondary Outcomes (2)

  • Change from baseline in self report ankle tightness

    Baseline to 3 weeks

  • Change from baseline in ankle range of motion

    Baseline to 3 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

True acupuncture

Other: Acupuncture

Sham needle

SHAM COMPARATOR

Retractable acupuncture needles will be used. No true transcutaneous needling through the skin

Other: Sham needle

Interventions

AcupunctureOTHER

Single disposal needle to be used, 0.02 mm x 25 mm in length

Acupuncture
Sham needleOTHER

Retractable needle with no skin puncture

Sham needle

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of the patients between 55 to 70 years old
  • Time from stroke onset 12 months but less than 18 months
  • Clinical picture: symptoms of hemiparesis from ischemic or hemorrhage stroke which is confirmed with CAT scan or MRI, stable with vital signs
  • Independently ambulatory with/without a walking aid and with/without orthoses for 2 minutes
  • Exhibit spastic equinovarus hemiparesis gait on the affected side
  • Cognitive function level ≥ 23 with the total score on the MiniMental Status Examination

You may not qualify if:

  • History of more than one episode of stroke
  • Receiving Botox injections for treatment of spasticity
  • Medically unstable with life-threatening conditions, epileptic seizures, auto-immune disease, acute or chronic infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

RECRUITING

Related Publications (2)

  • Wu P, Mills E, Moher D, Seely D. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials. Stroke. 2010 Apr;41(4):e171-9. doi: 10.1161/STROKEAHA.109.573576. Epub 2010 Feb 18.

    PMID: 20167912BACKGROUND

  • Zhong C, Bai L, Dai R, Xue T, Wang H, Feng Y, Liu Z, You Y, Chen S, Tian J. Modulatory effects of acupuncture on resting-state networks: a functional MRI study combining independent component analysis and multivariate Granger causality analysis. J Magn Reson Imaging. 2012 Mar;35(3):572-81. doi: 10.1002/jmri.22887. Epub 2011 Nov 8.

    PMID: 22069078BACKGROUND

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Enoch K Ho, MPh

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hoover, PhD

CONTACT

905-389-4411hoover@hhsc.ca

Study Design

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

Study Record Dates

First Submitted

February 19, 2014

First Posted

March 13, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Plan to share data at conferences and journals related to stroke and/or physiotherapy/acupuncture

Locations

CA(1)