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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Hamilton Health Sciences Corporation
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT02085642
First received: February 19, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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?

Methodology

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).


Condition Intervention
Stroke
Other: Acupuncture
Other: Sham needles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Change from baseline in 2 minute walk test [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in self report ankle tightness [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in ankle range of motion [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer


Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 needles
Retractable needle with no skin puncture

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Age of the patients between 55 - 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 Mini-Mental 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085642

Contacts
Contact: Patricia Hoover, PhD 905-389-4411 ext 42097 hoover@hhsc.ca

Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Enoch K Ho, MPh    905-389-4411 ext 42097    hoenoch@hhsc.ca   
Principal Investigator: Enoch K Ho, MPh         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Enoch K Ho, MPh Hamilton Health Sciences Corporation
  More Information

Publications:
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02085642     History of Changes
Other Study ID Numbers: HHSCSTROKEACPILOT1
Study First Received: February 19, 2014
Last Updated: March 7, 2014
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Hamilton Health Sciences Corporation:
Stroke
Acupuncture
Gait
Spasticity

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

ClinicalTrials.gov processed this record on August 20, 2014