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Neurological DisorderNCT05230849

Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Ultrasound-guided Dry Needling in Stroke Patients.

A study testing dry needling and convencional treatment in people with Neurological Disorder, run by Universidad Católica de Ávila at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neurological Disorder
What is being tested?
dry needling and convencional treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
12 Feb 2022to 11 Apr 2022
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • left middle cerebral artery infarction
  • impaired stability during walking
  • patient between the age range 18 to 70 years old

Who cannot join

  • patient under 18 years of age
  • patients over 70 years of age
  • undiagnosed left middle cerebral artery infarction patients

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Católica de Ávila

    Ávila, 05005

Other trials in Spain

About this study

Official title: 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.

Being tested
dry needling, convencional treatment
Keywords
dry needling, physiotherapy techniques, anterior tibial muscle, posterior tibial muscle, Neurological Disorder
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dry needlingDevice

    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.

  • convencional treatmentOther

    is a physiotherapy treatment for neurological patients

Study groups in NCT05230849
Study groupRoleWhat they receive
control groupActive comparatorconventional physiotherapy treatment
Receives: Other: convencional treatment
dry needling treatmentExperimentalgroup that includes a dry needling treatment on the tibialis anterior and posterior muscles.
Receives: Device: dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. walking motor skills

    measures of gait motor ability using the time up ang go test.

    Measured: 1 hour

  2. spasticity

    measurements of spatiality using the modified Ashworth scale

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start12 Feb 2022
  3. Primary completion3 Mar 2022
  4. Study completion11 Apr 2022

Resources

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
Single blind
Who is masked
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230849
Sponsor's protocol ID
13/01/2022
Status last verified
Jun 2022
First submitted
13 Jan 2022
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23910514

  • 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.

    PubMed 32488238

  • 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.

    PubMed 29986902

  • 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.

    PubMed 32815384

  • 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.

    PubMed 27167369

  • 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.

    PubMed 25199825

  • 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.

    PubMed 28222554

  • 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.

    PubMed 32115341

  • 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.

    PubMed 30476691

  • Sanchez Mila Z, Velazquez Saornil J, Campon Chekroun A, Barragan Casas JM, Frutos Llanes R, Castrillo Calvillo A, Lopez Pascua C, Rodriguez Sanz D. Effect of Dry Needling Treatment on Tibial Musculature in Combination with Neurorehabilitation Treatment in Stroke Patients: Randomized Clinical Study. Int J Environ Res Public Health. 2022 Sep 28;19(19):12302. doi: 10.3390/ijerph191912302.

    PubMed 36231604

Questions about this trial

What is this clinical trial studying?

A study testing dry needling and convencional treatment in people with Neurological Disorder, run by Universidad Católica de Ávila at 1 site in Spain.

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 3 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: finished, as of the sponsor's last update on 30 Jun 2022. 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 Spain. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

walking motor skills (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT05230849, which also lists 10 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 30 Jun 2022.

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