Knee InjuriesNCT05256420
Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects
A study testing Kinesiotape in people with Knee Injuries and Cruciate Ligament Rupture, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Injuries, Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- What is being tested?
- Kinesiotape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2021to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Víctor Navarro López, PhD student, 697371075, victor.navarro@urjc.es
Isabel María Alguacil Diego, MD PhD
About this study
Official title: 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.
- Conditions
- Knee Injuries, Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Motor Control, Balance
- Being tested
- Kinesiotape, Sham Bandage
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
Application of a kinesiotape bandage on the knee.
Sham BandageDevice
Application of a sham bandage on the knee.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | Application of a kinesiotape bandage on the knee. Receives: Device: Kinesiotape |
| Sham Bandage | Sham comparator | Application of a sham bandage on the knee. Receives: Device: Sham Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start10 Jan 2021
- Primary completion10 Jul 2022 (estimated)
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256420
- Sponsor's protocol ID
- KTBALANCE080222
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotape on Postural Control in Subjects With Non-operated Anterior Cruciate Ligament (ACL) Injuries: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05256420
- Acronym / sponsor ID
- KTBALANCE080222
- Conditions
- Knee Injuries, Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Motor Control, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Device: KinesiotapeApplication of a kinesiotape bandage on the knee. |
| Sham Bandage | Sham comparator | Device: Sham BandageApplication of a sham bandage on the knee. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapeApplication of a kinesiotape bandage on the knee. | Device | Kinesiotape |
| Sham BandageApplication of a sham bandage on the knee. | Device | Sham Bandage |
Primary outcome
Motor Control Test (MCT)
Time frame: 10 minutes
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).
Time frame: 10 minutes
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).
Time frame: 10 minutes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape in people with Knee Injuries and Cruciate Ligament Rupture, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Víctor Navarro López, PhD student (697371075, victor.navarro@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Control Test (MCT) (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.