- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02085642
Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants (HHSCSTROKEAC)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 8E7
- Werving
- Hamilton Health Sciences
-
Contact:
- Enoch K Ho, MPh
- Telefoonnummer: 42097 905-389-4411
- E-mail: hoenoch@hhsc.ca
-
Hoofdonderzoeker:
- Enoch K Ho, MPh
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Acupuncture
True acupuncture
|
Single disposal needle to be used, 0.02 mm x 25 mm in length
|
Sham-vergelijker: Sham needle
Retractable acupuncture needles will be used.
No true transcutaneous needling through the skin
|
Retractable needle with no skin puncture
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline in 2 minute walk test
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline in self report ankle tightness
Tijdsspanne: 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
Tijdsspanne: Baseline to 3 weeks
|
Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer
|
Baseline to 3 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Enoch K Ho, MPh, Hamilton Health Sciences Corporation
Publicaties en nuttige links
Algemene publicaties
- 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.
- Zhong 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HHSCSTROKEACPILOT1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .