NCT05230849

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

February 12, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

19 days

First QC Date

January 13, 2022

Last Update Submit

June 28, 2022

Conditions

Neurological Disorder

Keywords

dry needlingphysiotherapy techniquesanterior tibial muscleposterior tibial muscleNeurological Disorder

Outcome Measures

Primary Outcomes (2)

  • walking motor skills

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

    1 hour

  • spasticity

    measurements of spatiality using the modified Ashworth scale

    1 hour

Study Arms (2)

control group

ACTIVE COMPARATOR

conventional physiotherapy treatment

Other: convencional treatment

dry needling treatment

EXPERIMENTAL

group that includes a dry needling treatment on the tibialis anterior and posterior muscles.

Device: dry needling

Interventions

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.

dry needling treatment
convencional treatmentOTHER

is a physiotherapy treatment for neurological patients

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (10)

  • 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.

    PMID: 23910514BACKGROUND

  • 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.

    PMID: 32488238BACKGROUND

  • 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.

    PMID: 29986902RESULT

  • 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.

    PMID: 32815384RESULT

  • 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.

    PMID: 27167369RESULT

  • 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.

    PMID: 25199825RESULT

  • 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.

    PMID: 28222554RESULT

  • 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.

    PMID: 32115341RESULT

  • 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.

    PMID: 30476691RESULT

  • 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.

    PMID: 36231604DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Simple blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 9, 2022

Study Start

February 12, 2022

Primary Completion

March 3, 2022

Study Completion

April 11, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)