NCT02608294

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

November 15, 2015

Last Update Submit

November 17, 2015

Conditions

Keywords

strokegaitbalance

Outcome Measures

Primary Outcomes (1)

  • Ankle angle during 1 gait cycle

    Angle measured from the ankle joint during some phases of the gait cycle.

    30 seconds

Secondary Outcomes (1)

  • Balance

    20 seconds

Study Arms (2)

Experimental Group

EXPERIMENTAL

Kinesio Taping Procedure application with 35% strain.

Device: Kinesio Taping

Sham Group

SHAM COMPARATOR

Kinesio Taping Sham procedure application without strain.

Device: Kinesio Taping Sham

Interventions

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.

Experimental Group

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.

Sham Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Fisioterapia - Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (2)

  • Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.

    PMID: 23306413BACKGROUND
  • Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.

    PMID: 22124445BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Danielly Gomes, B.S.

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Degree in Physiotherapy

Study Record Dates

First Submitted

November 15, 2015

First Posted

November 18, 2015

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations