Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
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
January 10, 2021
CompletedFirst Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedFebruary 25, 2022
February 1, 2022
1.5 years
February 10, 2022
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Kinesiotape
EXPERIMENTALApplication of a kinesiotape bandage on the knee.
Sham Bandage
SHAM COMPARATORApplication of a sham bandage on the knee.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 25, 2022
Study Start
January 10, 2021
Primary Completion
July 10, 2022
Study Completion
August 10, 2022
Last Updated
February 25, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share