Dry Needling in Patients Who Had Experience Stroke

Study Overview
=================
Brief 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

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Dry needling
* Other: Bobath


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry needling<br>The experimental group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. In addition, this group will receive a single session of dry needling into the tibialis posterior muscle with a disposable stainless steel needle (0.3mm x 50mm) | Other: Dry needling<br>* 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.<br>|
| Active Comparator: Bobath<br>This group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. | Other: Bobath<br>* Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Dry needling, Spasticity, Motor function, Stabilometry