Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants (HHSCSTROKEAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02085642
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : August 23, 2016
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Acupuncture Other: Sham needle Not Applicable

Detailed Description:

Background: Stroke is one of the leading causes of death and disability in Canada. There are approximately 50,000 new cases every year. Stroke victims often experience decreased mobility and significant disability as a result of impaired motor control and velocity-dependent muscle hypertonus (spasticity) in the lower extremity. Over the past 25 years, there has been an increasing interest in the use of acupuncture for the management of stroke-related neurological deficits.

Research questions: Is acupuncture more effective than sham treatment in reducing lower extremity spasticity, and improving gait speed in the chronic phase of stroke recovery?


Recruitment: Forty patients will be recruited from the out patient rehabilitation program of a university affiliated teaching hospital.

Group Assignment and Blinding:

The study design is a randomized double blind format. Once identified, interested patients will be screened for eligibility by an intake secretary and randomly assigned to sham (n=20) or acupuncture treatment (n=20) groups using a computer random-number-generation system. Sealed envelopes containing the group assignment will be delivered to acupuncture-trained therapists delivering sham or true acupuncture treatment. Treating therapists' interactions will be standardized to minimize therapist/participant interaction bias Treating therapists will remain blinded to outcome assessment results. Patients will be blinded to the receipt of true acupuncture or sham needles. Outcome measurements will be done by a single assessor who is blinded to the group assignment.

Intervention: Subjects will attend 4 acupuncture treatments sessions within a 3 week period. Needles will be applied to the following acupuncture points: Jiao's foot motor sensory scalp points (2 in total) and 2 additional standardized acupuncture points in the lower legs bilaterally based on Traditional Chinese Medicine (TCM) approach. Treatment needles are pre-sterilized single disposable type, 0.20 mm size and 40 mm in length. The locations of the acupuncture point will be cleaned with alcohol (99%) swab. Needles will be left in place for 20 minutes. In the true acupuncture group, needles will be inserted to a depth at which participants report a tingling sensation (as described De-qi in TCM approach). Subjects randomized to the control group will be treated with retractable needles to avoid transcutaneous insertion at the same acupuncture points.

Outcome Measures: The following outcome measures will be assessed by a blinded assessor. Primary outcome measures:2-minute walk test. Secondary outcome measures: ankle range of motion and self report soft tissue tightness. The outcome measures time frame is set at from baseline to the completion of the intervention period at 3 weeks.

Analysis: Descriptive statistics including mean, standard deviation and frequencies will be used to describe the study participants, as appropriate. Paired t-test will be used for the parametric variables, number of steps per minute, distance on a 2-minute walk test and dorsi-flexion range of motion. Significance is set at p smaller than 0.05. All statistical analysis will be two sided and performed with SPSS (V21).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
True acupuncture
Other: Acupuncture
Single disposal needle to be used, 0.02 mm x 25 mm in length

Sham Comparator: Sham needle
Retractable acupuncture needles will be used. No true transcutaneous needling through the skin
Other: Sham needle
Retractable needle with no skin puncture

Primary Outcome Measures :
  1. Change from baseline in 2 minute walk test [ Time Frame: Baseline to 3 weeks ]
    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

Secondary Outcome Measures :
  1. Change from baseline in self report ankle tightness [ Time Frame: Baseline to 3 weeks ]
    Participant report outcome measure (PROM) - ankle tightness - a self report outcome measures has been widely used for pain in a format of a 10-point visual analog scale (VAS). Recent studies showed the reliability of the adaption of PROM to cover other clinical outcomes and the re is extensive discussion on minimal detectable clinical improvement. Ankle tightness in Achilles tendon will be recorded as a PROM on a 10-point scale with 0 being no tightness and 10 is the most.

  2. Change from baseline in ankle range of motion [ Time Frame: Baseline to 3 weeks ]
    Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02085642

Contact: Patricia Hoover, PhD 905-389-4411 ext 42097

Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Enoch K Ho, MPh    905-389-4411 ext 42097   
Principal Investigator: Enoch K Ho, MPh         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Enoch K Ho, MPh Hamilton Health Sciences Corporation

Responsible Party: Hamilton Health Sciences Corporation Identifier: NCT02085642     History of Changes
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data at conferences and journals related to stroke and/or physiotherapy/acupuncture

Keywords provided by Hamilton Health Sciences Corporation:

Additional relevant MeSH terms:
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms