Recruiting

Acupuncture

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT02085642

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 55 - 70

Healthy Volunteers: Accepted

Interventions

Acupuncture

Sham needle

Study Details

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.

Conditions

Stroke

Study ID

NCT02085642

Start date

Mar, 2015

Status verified date

Aug, 2016

Completion date

Apr, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acupuncture

True acupuncture

sham comparator: Sham needle

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

Interventions

Acupuncture

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

Sham needle

Retractable needle with no skin puncture

Primary outcome measure

  • Change from baseline in 2 minute walk test [ Time Frame: Baseline to 3 weeks ]

Central Contacts and Locations

Central contacts

Patricia Hoover, PhD

905-389-4411hoover@hhsc.ca

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 8E7

Contacts

Enoch K Ho, MPh

905-389-4411hoenoch@hhsc.ca

Principal Investigator:

Enoch K Ho, MPh

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Aug 23, 2016

Last verified

Aug, 2016

Keywords

  • Stroke
  • Acupuncture
  • Gait
  • Spasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2016-08-23.