Dry Needling in Patients Who Had Experience Stroke

Stroke Clinical Trial

Official title:

Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02579291
• Other study ID #: URJC 07-2015
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: February 25, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Universidad Rey Juan Carlos
• Contact: CESAR FERNANDEZ-DE-LAS-PEÑAS, PhD
• Phone: +34914888884
• Email: cesar.fernandez[@]urjc.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• First-ever unilateral stroke;

• hemiplegia resulting from stroke;

• unilateral equinovarus gait with independent walk;

• able to ambulate without supporting devices

Exclusion Criteria:

• recurrent stroke;

• previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months

• not independent in the basic activities of daily living

• cognitive deficits;

• progressive or severe neurologic diseases;

• fear to needles;

• any contraindication for dry needling

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Dry needling
Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
• Bobath
Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity

Locations

Country	Name	City	State
Spain	Cesar Fernandez-de-Las-Peñas	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in spasticity before and 10 minutes after the intervention	Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4.	Baseline and immediate after the intervention	Yes
Secondary	Changes in motor function before and 10 minutes after the intervention	The Fugl-Meyer evaluation will be used to determine motor impairments and physical recovery of patients who had experienced a stroke	Baseline and immediate after the intervention	Yes
Secondary	Changes in stabilometry outcomes before and 10 minutes after the intervention	The time reaction will be assessed as stabilometric data from each patient.	Baseline and immediate after the intervention	Yes