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Influence of Kinesio Taping® in Paretic Tibialis Anterior Muscle During Patient Gait and Balance After Stroke

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ClinicalTrials.gov Identifier: NCT02608294
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Danielly Laís Pereira Lima Gomes, Universidade Federal de Pernambuco

Brief Summary:
A pilot study was conducted, randomized, triple-blind study with allocation concealment. Which consisted in the application of KT in the anterior tibial muscle for 24 hours. 14 subjects were randomized into 2 groups: intervention (with voltage) and sham (no pressure). Patient's gait footage was shot in the opening balance of phases, average balance and initial contact (first without the application of Kinesio Taping and after 24 hours of application) to be measured the angles of the ankle joints, knee and hip. Balance was assessed by the Biodex Balance System platform, configured to analyze the postural stability in level eight. The mean differences were assessed (MD) between groups and confidence interval (CI) of 95%.

Condition or disease Intervention/treatment Phase
Stroke Device: Kinesio Taping Device: Kinesio Taping Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Kinesio Taping® in Paretic Tibialis Anterior Muscle at Joint Dynamics During Patient Gait and Balance After Stroke: A Pilot Study
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Experimental Group
Kinesio Taping Procedure application with 35% strain.
Device: Kinesio Taping
The patient is placed on a stretcher, his ankle positioned in plantar flexion and inversion, a measure was held between Point A and B with a tape measure, right after the KT was removed from the paper and cut to the same extent. The KT was pulled to its maximum limit and measured with a tape for a second evaluator. This measure found after the maximum tensile strain represented 100% and a rule of three was applied in order to find the 35% voltage for muscle activation. After finding the measure of 35% strain in centimeters, the evaluator cut KT this measurement and the same was discarded. Finally the tape was positioned at Point A; pulled up to Point B; and fixed. This procedure was carried out with the ankle positioned in plantar flexion and inversion.

Sham Comparator: Sham Group
Kinesio Taping Sham procedure application without strain.
Device: Kinesio Taping Sham
The sham group received the tape applied without tension. The patient was positioned supine; the ankle was placed in a neutral position (90 degrees); and measured between Point A and Point B with a tape measure placed on the skin was performed. Once registered this measure in centimeters the evaluator cut the KT with the same measure, but without the presence of paper attached to it to ensure that there was no tension, because the KT needs a minimum voltage to be applied on paper. After measured and cut the KT, it was applied to the patient in the supine position with the ankle positioned at 90 degrees with no traction.




Primary Outcome Measures :
  1. Ankle angle during 1 gait cycle [ Time Frame: 30 seconds ]
    Angle measured from the ankle joint during some phases of the gait cycle.


Secondary Outcome Measures :
  1. Balance [ Time Frame: 20 seconds ]
    Observation of the patient's balance on the balance measurement platform (Biodex Balance System).



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of stroke Ischemic or Hemorrhagic proven by clinical examination and imaging;
  • Stroke with minimal evolution of six months (chronic hemiparetic more than 6 months after injury);
  • Kinetic-functional Diagnostic hemiparesis, spasticity degrees with between 1 and 2 in Ashworth scale modified for muscle group of ankle plantar flexor;
  • People over 21 years;
  • What do not use assistive devices while driving;
  • Absence of cognitive impairment (Mini-Mental State Examination MMSE - illiterate ≤ 15 points, 1-11 years of schooling ≤ 22 with higher education to 11 years ≤ 27)

Exclusion Criteria:

  • Presented range of motion to lowest passive dorsiflexion than 5 degrees;
  • If there were missing during the intervention period;
  • Presented clinical comorbidities that interfere in the intervention such as high blood pressure or cardiac arrhythmias
  • And submit pathological deformities of the lower limbs or presence of scabs on malleolus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608294


Locations
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Brazil
Departamento de Fisioterapia - Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil, 50670-901
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Danielly Gomes, B.S. Universidade Federal de Pernambuco

Publications:
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Responsible Party: Danielly Laís Pereira Lima Gomes, Degree in Physiotherapy, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02608294    
Other Study ID Numbers: 15238913.9.0000.5208
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Danielly Laís Pereira Lima Gomes, Universidade Federal de Pernambuco:
stroke
gait
balance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases