- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230849
Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Ultrasound-guided Dry Needling in Stroke Patients.
Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Dry Needling in Stroke Patients.
The aim of the study is to assess the efficacy of dry needling in stroke patients in combination with intensive neurological physiotherapy.
together with intensive neurological physiotherapy treatment. Randomised and blinded experimental study control group where the sample recruited was 20 patients, who were randomly assigned to a control group.
randomly assigned to a control group, where they received intensive treatment, or to an intervention group, where they received intervention group, where they received ultrasound-guided dry needling of the tibialis anterior and posterior muscles followed by an intensive followed by intensive neurological physiotherapy treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ávila, Spain, 05005
- Universidad Católica de Ávila
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- left middle cerebral artery infarction
- impaired stability during walking
- patient between the age range 18 to 70 years old
Exclusion Criteria:
- patient under 18 years of age
- patients over 70 years of age
- undiagnosed left middle cerebral artery infarction patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
conventional physiotherapy treatment
|
is a physiotherapy treatment for neurological patients
|
|
Experimental: dry needling treatment
group that includes a dry needling treatment on the tibialis anterior and posterior muscles.
|
is a physiotherapy treatment for neurological patients and studies the efficacy of dry needling by studying several pre-treatment and post-treatment variables after the experimental treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
walking motor skills
Time Frame: 1 hour
|
measures of gait motor ability using the time up ang go test.
|
1 hour
|
|
spasticity
Time Frame: 1 hour
|
measurements of spatiality using the modified Ashworth scale
|
1 hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Edmiaston J, Connor LT, Steger-May K, Ford AL. A simple bedside stroke dysphagia screen, validated against videofluoroscopy, detects dysphagia and aspiration with high sensitivity. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):712-6. doi: 10.1016/j.jstrokecerebrovasdis.2013.06.030. Epub 2013 Jul 30.
- Hernandez-Ortiz AR, Ponce-Luceno R, Saez-Sanchez C, Garcia-Sanchez O, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI. Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial. Pain Med. 2020 Nov 1;21(11):2939-2947. doi: 10.1093/pm/pnaa132.
- Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.
- Cuenca Zaldivar JN, Calvo S, Bravo-Esteban E, Oliva Ruiz P, Santi-Cano MJ, Herrero P. Effectiveness of dry needling for upper extremity spasticity, quality of life and function in subacute phase stroke patients. Acupunct Med. 2021 Aug;39(4):299-308. doi: 10.1177/0964528420947426. Epub 2020 Aug 20.
- Mendigutia-Gomez A, Martin-Hernandez C, Salom-Moreno J, Fernandez-de-Las-Penas C. Effect of Dry Needling on Spasticity, Shoulder Range of Motion, and Pressure Pain Sensitivity in Patients With Stroke: A Crossover Study. J Manipulative Physiol Ther. 2016 Jun;39(5):348-358. doi: 10.1016/j.jmpt.2016.04.006. Epub 2016 May 7.
- Salom-Moreno J, Sanchez-Mila Z, Ortega-Santiago R, Palacios-Cena M, Truyol-Dominguez S, Fernandez-de-las-Penas C. Changes in spasticity, widespread pressure pain sensitivity, and baropodometry after the application of dry needling in patients who have had a stroke: a randomized controlled trial. J Manipulative Physiol Ther. 2014 Oct;37(8):569-79. doi: 10.1016/j.jmpt.2014.06.003. Epub 2014 Sep 8.
- Fakhari Z, Ansari NN, Naghdi S, Mansouri K, Radinmehr H. A single group, pretest-posttest clinical trial for the effects of dry needling on wrist flexors spasticity after stroke. NeuroRehabilitation. 2017;40(3):325-336. doi: 10.3233/NRE-161420.
- Wu WX, Zhou CY, Wang ZW, Chen GQ, Chen XL, Jin HM, He DR. Effect of Early and Intensive Rehabilitation after Ischemic Stroke on Functional Recovery of the Lower Limbs: A Pilot, Randomized Trial. J Stroke Cerebrovasc Dis. 2020 May;29(5):104649. doi: 10.1016/j.jstrokecerebrovasdis.2020.104649. Epub 2020 Feb 27.
- Lee P, Tse CY. Calibration of wrist-worn ActiWatch 2 and ActiGraph wGT3X for assessment of physical activity in young adults. Gait Posture. 2019 Feb;68:141-149. doi: 10.1016/j.gaitpost.2018.11.023. Epub 2018 Nov 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/01/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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