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Completed

NCT Number: NCT02690493

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

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.

Functional Taping

Other

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.

Acupuncture and Functional Taping

Other

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 outcomes

  1. The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Modified Ashworth Scale

Secondary outcomes

  1. The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Wolf Motor Function Test

  2. The change of frequency of movement of upper limb after 12 sessions of intervention

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Motor Activity Log

  3. The change of quality of movement of upper limb after 12 sessions of intervention

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Motor Activity Log

  4. The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Manual Goniometry

  5. The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale

    Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.

    Visual Analogue Scale of Pain

Other outcomes

  1. Measure of Cognitive Impairment required to include the patient in the study assessed using Mini Mental State Examination.

    Time frame: Immediately before the inclusion of patient in the study (before the first session of intervention).

    Mini Mental State Examination

Sponsors and collaborators

Lead sponsor

Fernanda Cechetti

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2016
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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