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

Primary Purpose

Knee Injuries, Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesiotape
Sham Bandage
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Rey Juan CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Kinesiotape

Sham Bandage

Arm Description

Application of a kinesiotape bandage on the knee.

Application of a sham bandage on the knee.

Outcomes

Primary Outcome Measures

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.
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).
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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2022
Last Updated
February 24, 2022
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05256420
Brief Title
Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects
Official Title
Effect of Kinesiotape on Postural Control in Subjects With Non-operated Anterior Cruciate Ligament (ACL) Injuries: a Randomized, Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
July 10, 2022 (Anticipated)
Study Completion Date
August 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Motor Control, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Experimental
Arm Description
Application of a kinesiotape bandage on the knee.
Arm Title
Sham Bandage
Arm Type
Sham Comparator
Arm Description
Application of a sham bandage on the knee.
Intervention Type
Device
Intervention Name(s)
Kinesiotape
Intervention Description
Application of a kinesiotape bandage on the knee.
Intervention Type
Device
Intervention Name(s)
Sham Bandage
Intervention Description
Application of a sham bandage on the knee.
Primary Outcome Measure Information:
Title
Motor Control Test (MCT)
Description
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.
Time Frame
10 minutes
Title
Unilateral Stance (US).
Description
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).
Time Frame
10 minutes
Title
Star Excursión Balance Test (SEBT).
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Víctor Navarro López, PhD student
Phone
697371075
Email
victor.navarro@urjc.es
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Víctor Navarro López, PhD student
Phone
697371075
Email
victor.navarro@urjc.es
First Name & Middle Initial & Last Name & Degree
Isabel María Alguacil Diego, MD PhD
First Name & Middle Initial & Last Name & Degree
Francisco Molina Rueda, PT PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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