The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke

Study Overview
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Brief Summary
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The purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke.

Detailed Description
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Acupuncture and taping have emerged as treatment alternatives for many diseases with positive and satisfactory results. Thus, acupuncture seeks to balance all physiological systems, using specific points on the body where needles are inserted. In turn, the use of taping is associated to various benefits such as improved blood and lymphatic function. In addition, it assists in the correction of muscle function and in the decrease of pain for neurological suppression. The constant afferent mechanical and somatosensory stimuli are perceived in cortical level and may produce motor unit recruitment and contribute to neuroplasticity of the nervous system. Thus, this research aims to analyze the effects of Acupuncture associated with Functional Taping on patients' upper limb with chronic hemiparesis after Stroke through a prospective, randomized intervention. Seventy-five patients will be evaluated before and after intervention with Acupuncture and / or Function Taping, divided into three groups (Acupuncture, Functional Taping and Acupuncture plus Functional Taping). The evaluation will consist of Isokinetic, Mini-Mental State Examination, Modified Ashworth Scale, Motor Activity Log, Wolf Motor Function Test and Visual Analog Scale of Pain. The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.

Official Title
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The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke

Conditions
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Stroke, Cerebrovascular Stroke

Intervention / Treatment
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* Procedure: Acupuncture
* Other: Functional Taping
* Other: Acupuncture and Functional Taping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stroke diagnosis for at least six (06) months, who present hemiparesis in upper limb; To accept participate in the study by signing theTerms of Consent; Do not have any cognitive impairment. Exclusion Criteria: Do not follow the inclusion criteria; To present shoulder subluxation or dislocation, shoulder pain syndrome or amputations (with or without the use of aids); To present any allergic reaction due to use of bandage and/or do not adapt to treatment with needles.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture Only<br>Patients will be treated with acupuncture only. | Procedure: Acupuncture<br>* Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, three times a week, during twelve sessions.<br>|
| Active Comparator: Functional Taping Only<br>Patients will be treated with taping only. | Other: Functional Taping<br>* Elastic taping is positioned directly on the skin (on the back of the fingers, hand, forearm and arm - paretic upper limb), three times a week, during twelve sessions. The patient should keep the taping on the skin for two days.<br>|
| Experimental: Acupuncture and Functional Taping<br>Patients will be treated with both acupuncture and taping at the same session. | Other: Acupuncture and Functional Taping<br>* Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, then elastic taping is positioned directly on skin (on the back of the fingers, hand, forearm and arm - paretic upper limb). Both procedures are performed three times a week, during twelve sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale | Modified Ashworth Scale | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test | Wolf Motor Function Test | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. | 
| The change of frequency of movement of upper limb after 12 sessions of intervention | Motor Activity Log | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. | 
| The change of quality of movement of upper limb after 12 sessions of intervention | Motor Activity Log | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. | 
| The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer | Manual Goniometry | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. | 
| The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale | Visual Analogue Scale of Pain | Immediately before the first session of intervention and 2 days after the last (12th) session of intervention. |