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

Phase 2

Completed

• Conditions: Stroke; Cerebrovascular Stroke
• Interventions: Other: Acupuncture and Functional Taping; Other: Functional Taping; Procedure: Acupuncture

• Registration Number: NCT02690493
• Lead Sponsor: Fernanda Cechetti

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-14
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture and Functional Taping	Acupuncture and Functional Taping	Patients will be treated with both acupuncture and taping at the same session.
Functional Taping Only	Functional Taping	Patients will be treated with taping only.
Acupuncture Only	Acupuncture	Patients will be treated with acupuncture only.

Primary Outcome Measures

Name	Time	Method
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale	Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.	Modified Ashworth Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Federal University of Health Science of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil