Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects

Effect of Kinesiotape on Postural Control in Subjects With Non-operated Anterior Cruciate Ligament (ACL) Injuries: a Randomized, Double-blind Clinical Trial

Anterior cruciate ligament (ACL) injuries are the most common traumatic knee ligament injuries. This lesion has a devastating influence on patients' activity levels and quality of life. ACL injuries are most frequent between the ages of 15 and 45 years. Individuals who choose conservative treatment must undergo physical therapy to strengthen muscles around the knee, notably the quadriceps femoris and hamstring muscles. It had been described that in absence of surgical treatment, the knee remains unstable and vulnerable to injury having a much poorer prognosis. This study aims to analyze the effectiveness of neuromuscular taping (kinesiotape) compared to placebo in patients with non-operated anterior cruciate ligament rupture.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Knee Injuries; Cruciate Ligament Rupture; Balance; Motor Control
• Intervention / Treatment: Device: Kinesiotape; Device: Sham Bandage

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Víctor Navarro López, PhD student; Phone Number: 697371075; Email: victor.navarro@urjc.es

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Universidad Rey Juan Carlos
      • Contact: Víctor Navarro López, PhD student; Phone Number: 697371075; Email: victor.navarro@urjc.es
      • Principal Investigator: Isabel María Alguacil Diego, MD PhD
      • Sub-Investigator: Francisco Molina Rueda, PT PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both sexes, diagnosed with ACL rupture (clinical and imaging) between 18 and 60 years old and not yet operated.
• Rupture isolated or combined with meniscopathy including bucket-handle.
• Partial or complete ACL rupture.

Exclusion Criteria:

• Cognitive impairment that prevents understanding of simple commands.
• Unhealed wounds in the knee complex.
• Severe skin diseases and alterations.
• Previous history of allergy to any type of bandage.
• Neurological disease with impaired balance.
• Manifest deformity of the musculoskeletal system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesiotape; Application of a kinesiotape bandage on the knee.	Device: Kinesiotape; Application of a kinesiotape bandage on the knee.
Sham Comparator: Sham Bandage; Application of a sham bandage on the knee.	Device: Sham Bandage; Application of a sham bandage on the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Control Test (MCT)	The MCT assesses the responsiveness of the automatic motor system and recovery from unexpected perturbations of the support surface quickly and efficiently. The MCT provides latencies (time in milliseconds between the onset of translation during the MCT and the onset of the participants' response to the translational movement of the support surface). Latencies were the average of the performance of both feet.	10 minutes
Unilateral Stance (US).	The US balance check is a test commonly used in clinical practice to assess balance. This assessment quantifies the ability to maintain postural stability while standing on US with EO and closed. The duration of each test is 10 s. The length of each trial is 10 s. Mean center of gravity (COG) sway velocity (º/s), the ratio of the distance travelled by the COG to the time of the trial, was calculated on each leg with EO and with eyes closed (EC).	10 minutes
Star Excursión Balance Test (SEBT).	The SEBT is a test that provides a significant challenge to the postural control system. SEBT involves the participant maintaining a base of support with one leg while reaching maximally in different directions with the opposite leg, without compromising the base of support of the supporting leg [Gribble PA, Hertel J. Considerations for normalizing measures of the Star Excursion Balance Test. Measurement in physical education and exercise science, 2003;7(2),89-100]. This test has demonstrated high reliability of measurements, showing sensitivity in screening for functional deficits related to musculoskeletal injuries	10 minutes

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Anticipated): July 10, 2022
• Study Completion (Anticipated): August 10, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: KTBALANCE080222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No