Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency

NCT01501188 | Completed Phase 1

• 1 other identifier: UGR-409
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle activation during gait and on Range of ankle motion in postmenopausal females with Chronic Venous Insufficiency in initial stages in comparison to a placebo control group.

Conditions

Chronic Venous Insufficiency

Keywords

Chronic Venous Insufficiency; Kinesio Taping; Electromyography; Range of ankle motion

Outcome Measures

Primary Outcomes (2)

• Change on surface electromyography in gastrocnemius muscles

  Muscle activity data during gait is sampled at 1600 Hz by surface electromyography, applying electrodes at medial gastrocnemius and lateral gastrocnemius level in both legs. We follow Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines for electrode placement and signal processing methods. The patient is instructed on the gait speed. After setting the speed-metronome, the electromyography image and activity is recorded for a total of seven seconds and expressed in microvolts units

  At baseline and 4 weeks.

• Change on range of ankle motion

  This variable is measured by using a digital goniometer(SG 110, Penny and Giles Biometrics Ltd;UK) during maximum dorsal and plantar flexion.A sensor is placed at 10 cm from the internal malleolus and another on the inner side of the foot, parallel to the axial axis and perpendicular to the tibial axis.The machine records the degrees of plantar and dorsal flexion from the neutral position of the ankle.

  Baseline and 4 weeks

Study Arms (2)

Kinesio taping

EXPERIMENTAL

Specific type of muscle and joint taping

Other: Kinesio Taping

Kinesio taping placebo

PLACEBO COMPARATOR

Kinesio taping placebo

Other: Placebo kinesio taping

Interventions

Kinesio Taping OTHER

The participants were randomly assigned to an experimental group, to received Kinesio Taping application for gastrocnemius muscle enhancement and functional correction of the ankle.The treatment was performed three times a week during a 4-week period.

Also known as: Neuromuscular tape

Kinesio taping

Placebo kinesio taping OTHER

Placebo-control group received treatment with a sham Kinesio Taping protocol to enhance gastrocnemius muscle function and dorsal ankle flexion.The strips used in this group did not follow the principles of tension and anatomic distribution of Kinesio technique.The treatment was performed three times a week during a 4-week period

Also known as: Neuromuscular taping placebo

Kinesio taping placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 75 years.
• Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)

You may not qualify if:

• Chronic Venous Insufficiency (\> grade C3)
• Arterial disorders
• Cardiorespiratory disease
• Contraindications for Kinesio Taping technique including thrombosis, wounds, severe trauma, generalized edema secondary to cardiac or renal problems, carcinomas, intolerability of/allergy to surgical tape and pregnancy.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, Granada, 18001, Spain

Location

Study Officials

• Carmen Moreno, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and teaching staff of the University of Granada

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 29, 2011
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

ES (1)