Clinical trial NCT04435561: Efficacy of Dry Needling in the Spasticity Post-stroke
Official title: Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spasticity, Muscle
Keywords: dry needling
spasticity
hypertonia
stroke
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in spasticity
timeFrame: 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.
Secondary outcomes:
measure: Changes in range of motion
timeFrame: 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.
measure: Changes in Motor function of the upper and lower limb
timeFrame: 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.
measure: Changes in Gait
timeFrame: 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.
measure: Changes in Physical disability
timeFrame: Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaga
name: Rocío Martin Valero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaga
name: Juan Antonio Armenta Peinado, PhD
role: STUDY_DIRECTOR
References: