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

August 22, 2016 updated by: Hamilton Health Sciences Corporation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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?

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).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 8E7
        • Recruiting
        • Hamilton Health Sciences
        • Contact:
        • Principal Investigator:
          • Enoch K Ho, MPh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 weeks
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
Baseline to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Enoch K Ho, MPh, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHSCSTROKEACPILOT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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