StrokeHHSCSTROKEACNCT02085642
Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants
A study testing Acupuncture in people with Stroke, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7
Enoch K Ho, MPh, 905-389-4411 ext. 42097, hoenoch@hhsc.ca
Enoch K Ho, MPh
About this study
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.
Read the 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).
- Conditions
- Stroke
- Being tested
- Acupuncture, Sham needle
- Keywords
- Stroke, Acupuncture, Gait, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Single disposal needle to be used, 0.02 mm x 25 mm in length
Sham needleOther
Retractable needle with no skin puncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | True acupuncture Receives: Other: Acupuncture |
| Sham needle | Sham comparator | Retractable acupuncture needles will be used. No true transcutaneous needling through the skin Receives: Other: Sham needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 weeks
Secondary outcomes (2)
Change from baseline in self report ankle tightness
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.
Measured: Baseline to 3 weeks
Change from baseline in ankle range of motion
Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enoch K Ho, MPh, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085642
- Sponsor's protocol ID
- HHSCSTROKEACPILOT1
- Acronym
- HHSCSTROKEAC
- Status last verified
- Aug 2016
- First submitted
- 19 Feb 2014
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Plan to share data at conferences and journals related to stroke and/or physiotherapy/acupuncture
Publications
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.
PubMed 20167912Zhong 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.
PubMed 22069078
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants
- ClinicalTrials.gov ID
- NCT02085642
- Acronym / sponsor ID
- HHSCSTROKEAC / HHSCSTROKEACPILOT1
- Conditions
- Stroke
- Keywords
- Stroke, Acupuncture, Gait, Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureTrue acupuncture |
| Sham needle | Sham comparator | Other: Sham needleRetractable acupuncture needles will be used. No true transcutaneous needling through the skin |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureSingle disposal needle to be used, 0.02 mm x 25 mm in length | Other | Acupuncture |
| Sham needleRetractable needle with no skin puncture | Other | Sham needle |
Primary outcome
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
2 secondary outcomes
Change from baseline in self report ankle tightness
Time frame: Baseline to 3 weeks
Change from baseline in ankle range of motion
Time frame: Baseline to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Background: PubMed 20167912Wu 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.
- Background: PubMed 22069078Zhong 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.
- Individual participant dataSharing planned: Yes. Plan to share data at conferences and journals related to stroke and/or physiotherapy/acupuncture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enoch K Ho, MPh principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Stroke, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Hoover, PhD (905-389-4411 ext. 42097, hoover@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 2 minute walk test (time frame: Baseline to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.