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

• Sponsor: Universidad Católica de Ávila (Other)
• Overall Status: Completed
• CT.gov ID: NCT05230849
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Disorder	Device: dry needling; Other: convencional treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Simple blind
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Dry Needling in Stroke Patients.
• Actual Study Start Date: Feb 12, 2022
• Actual Primary Completion Date: Mar 3, 2022
• Actual Study Completion Date: Apr 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group conventional physiotherapy treatment	Other: convencional 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.	Device: dry needling; 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.

Outcome Measures

Primary Outcome Measures

1. walking motor skills [1 hour]

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

2. spasticity [1 hour]

   measurements of spatiality using the modified Ashworth scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Católica de Ávila	Ávila		Spain	05005

Sponsors and Collaborators

• Universidad Católica de Ávila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• Hernández-Ortíz AR, Ponce-Luceño R, Sáez-Sánchez C, García-Sánchez O, Fernández-de-Las-Peñas C, de-la-Llave-Rincón 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.

• Responsible Party: JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila
• ClinicalTrials.gov Identifier: NCT05230849
• Other Study ID Numbers: 13/01/2022
• First Posted: Feb 9, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila: dry needling; physiotherapy techniques; anterior tibial muscle; posterior tibial muscle; Neurological Disorder
• Additional relevant MeSH terms: Nervous System Diseases

Study Results

No Results Posted as of Jun 30, 2022