The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
Primary Purpose
Stroke, Cerebrovascular Stroke
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Functional Taping
Acupuncture and Functional Taping
Sponsored by

About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Federal University of Health Science of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Acupuncture Only
Functional Taping Only
Acupuncture and Functional Taping
Arm Description
Patients will be treated with acupuncture only.
Patients will be treated with taping only.
Patients will be treated with both acupuncture and taping at the same session.
Outcomes
Primary Outcome Measures
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale
Modified Ashworth Scale
Secondary Outcome Measures
The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test
Wolf Motor Function Test
The change of frequency of movement of upper limb after 12 sessions of intervention
Motor Activity Log
The change of quality of movement of upper limb after 12 sessions of intervention
Motor Activity Log
The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer
Manual Goniometry
The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale
Visual Analogue Scale of Pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02690493
Brief Title
The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
Official Title
The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fernanda Cechetti
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Only
Arm Type
Active Comparator
Arm Description
Patients will be treated with acupuncture only.
Arm Title
Functional Taping Only
Arm Type
Active Comparator
Arm Description
Patients will be treated with taping only.
Arm Title
Acupuncture and Functional Taping
Arm Type
Experimental
Arm Description
Patients will be treated with both acupuncture and taping at the same session.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional Taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture and Functional Taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale
Description
Modified Ashworth Scale
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Secondary Outcome Measure Information:
Title
The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test
Description
Wolf Motor Function Test
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Title
The change of frequency of movement of upper limb after 12 sessions of intervention
Description
Motor Activity Log
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Title
The change of quality of movement of upper limb after 12 sessions of intervention
Description
Motor Activity Log
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Title
The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer
Description
Manual Goniometry
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Title
The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale
Description
Visual Analogue Scale of Pain
Time Frame
Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Other Pre-specified Outcome Measures:
Title
Measure of Cognitive Impairment required to include the patient in the study assessed using Mini Mental State Examination.
Description
Mini Mental State Examination
Time Frame
Immediately before the inclusion of patient in the study (before the first session of intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Della Méa Plentz, Doctor
Organizational Affiliation
Federal Universiity of Health Science of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Health Science of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90050170
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
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