Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaga
- Enrollment
- 40
- Primary Endpoint
- Changes in spasticity
Study Overview
Brief Summary
Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions.
This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First hemiplegic ischemic stroke.
- •Chronic stroke (stroke at least 6 months before the trial).
- •Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
- •Preserve cognitive capacity.
- •Being able to understand and follow simple instructions.
- •Not afraid of needles.
Exclusion Criteria
- •Recurrent stroke.
- •Subjects with cognitive disorders.
- •Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
- •Alteration of sensitivity.
- •Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
- •Hemorrhagic stroke.
- •Subjects who do not consent to participate in the study.
Outcomes
Primary Outcomes
Changes in spasticity
Time Frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement. The scale goes from 0 to 4 points. The higher the score, the greater the impact. Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Secondary Outcomes
- Changes in range of motion(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Gait(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Motor function of the upper and lower limb(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Physical disability(Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.)
Investigators
Rocío Martín Valero
PhD
University of Malaga