ACL RuptureNCT04954924
Effect of Kinesio Tape on Motor Function in Subjects With ACL Rupture
A study testing standardized physiotherapy program and Kinesio tape in people with ACL Rupture and Rehabilitation, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
Thirty-two participants with ACL rupture were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=16) participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control group - standardized physiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- ACL Rupture, Rehabilitation
- What is being tested?
- standardized physiotherapy program and Kinesio tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Feb 2010to 15 Jan 2015
- 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 35-year-old men;
- a normal contralateral knee,
- not a longer period than 3 months after ACL rupture.
Who cannot join
- Participants were excluded if either knee had previously been injured or had undergone surgery, if they had concurrent osteoarthritis, if they had injured the posterior cruciate ligament, lateral collateral ligament, or posterolateral complex of the knee, or if they had a grade III tear of the medial collateral ligament.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Long Term Effect of Kinesio Tape on Motor Function, Proprioception and Balance in Subjects With ACL Rupture
Thirty-two participants with ACL rupture were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=16) participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control group - standardized physiotherapy.
Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity
- Conditions
- ACL Rupture, Rehabilitation
- Being tested
- standardized physiotherapy program and Kinesio tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized physiotherapy program and Kinesio tapeOther
| Study group | Role | What they receive |
|---|---|---|
| Control group - standardized physiotherapy program | No intervention | The standardized physiotherapy program was designed on the basis of S. van Grinsven et al.'s (2010) rehabilitation protocol - was applied 4 weeks, 3 times per week, the duration of the procedure was 60 minutes. |
| Experimental group - standardized physiotherapy program and Kinesio tape | Experimental | The standardized physiotherapy program was designed on the basis of S. van Grinsven et al.'s (2010) rehabilitation protocol - was applied 4 weeks, 3 times per week, the duration of the procedure was 60 minutes. The Kinesio tape (KT) technique was chosen on the basis of K. Kase et al.'s (2003) recommendations. KT (Japan) was applied to the injured leg using muscular and functional-corrective techniques on the quadriceps femoris and the hamstring muscle. There were 6 KT procedures per participant in the experimental group. The CON group received KT only during the baseline and final assessment to assess short-term effect of KT. Receives: Other: standardized physiotherapy program and Kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and dynamic balance
Static and dynamic balance were measured by posturography method with a single piezoelectric force plate (KISTLER, Switzerland, Slimline System 9286) was used to measure postural sway activity.
Measured: 4 weeks
Muscle torque
The isometric and concentric torque of the knee extensor and flexor muscles of the non-injured and injured legs was measured using an isokinetic dynamometer (System 3; Biodex Medical Systems, Shirley, New York).
Measured: 4 weeks
Joint position sense test
Joint position sense test was used to measure proprioceptive accuracy. Joint position sense for both legs was assessed for all subjects using the Biodex System Isokinetic Dynamometer 3 (Biodex Medical System Inc., Shirley, NY, USA).Subjects actively extended the knee from the resting position (90°flexion) to one of two test positions: 80° or 40° flexion at 0,5°/s velocity. Subjects were instructed to actively reproduce this criterion angle and to stop knee motion, via a thumb switch. No feedback was provided.
Measured: 4 weeks
Secondary outcomes (3)
The Lysholm scale
The Lysholm scale does measure the domains of symptoms and complaints and does measure functioning in daily activities
Measured: 4 weeks
The Tegner scale
The Tegner scale measure the subjective functional activity
Measured: 4 weeks
VAS scale
The severity of pain was determined based on a numerical pain scale in which 0 symbolizes 'no pain' and 10 symbolizes 'maximum pain'
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Feb 2010
- Primary completion15 Jan 2015
- Study completion15 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL RuptureStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954924
- Sponsor's protocol ID
- LithuananianSportsU-6
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.
PubMed 35438677
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long Term Effect of Kinesio Tape on Motor Function, Proprioception and Balance in Subjects With ACL Rupture
- ClinicalTrials.gov ID
- NCT04954924
- Acronym / sponsor ID
- LithuananianSportsU-6
- Conditions
- ACL Rupture, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 15 Jan 2015 (actual)
- First posted
- 8 Jul 2021 (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.
Thirty-two participants with ACL rupture were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=16) participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control group - standardized physiotherapy.
Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - standardized physiotherapy program | No intervention | –The standardized physiotherapy program was designed on the basis of S. van Grinsven et al.'s (2010) rehabilitation protocol - was applied 4 weeks, 3 times per week, the duration of the procedure was 60 minutes. |
| Experimental group - standardized physiotherapy program and Kinesio tape | Experimental | Other: standardized physiotherapy program and Kinesio tapeThe standardized physiotherapy program was designed on the basis of S. van Grinsven et al.'s (2010) rehabilitation protocol - was applied 4 weeks, 3 times per week, the duration of the procedure was 60 minutes. The Kinesio tape (KT) technique was chosen on the basis of K. Kase et al.'s (2003) recommendations. KT (Japan) was applied to the injured leg using muscular and functional-corrective techniques on the quadriceps femoris and the hamstring muscle. There were 6 KT procedures per participant in the experimental group. The CON group received KT only during the baseline and final assessment to assess short-term effect of KT. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 - 35-year-old men;
- a normal contralateral knee,
- not a longer period than 3 months after ACL rupture.
Key exclusion criteria (1 listed)
- Participants were excluded if either knee had previously been injured or had undergone surgery, if they had concurrent osteoarthritis, if they had injured the posterior cruciate ligament, lateral collateral ligament, or posterolateral complex of the knee, or if they had a grade III tear of the medial collateral ligament.
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 |
|---|---|---|
| standardized physiotherapy program and Kinesio tape | Other | Experimental group - standardized physiotherapy program and Kinesio tape |
Primary outcome
Static and dynamic balance
Time frame: 4 weeks
Static and dynamic balance were measured by posturography method with a single piezoelectric force plate (KISTLER, Switzerland, Slimline System 9286) was used to measure postural sway activity.
Muscle torque
Time frame: 4 weeks
The isometric and concentric torque of the knee extensor and flexor muscles of the non-injured and injured legs was measured using an isokinetic dynamometer (System 3; Biodex Medical Systems, Shirley, New York).
Joint position sense test
Time frame: 4 weeks
Joint position sense test was used to measure proprioceptive accuracy. Joint position sense for both legs was assessed for all subjects using the Biodex System Isokinetic Dynamometer 3 (Biodex Medical System Inc., Shirley, NY, USA).Subjects actively extended the knee from the resting position (90°flexion) to one of two test positions: 80° or 40° flexion at 0,5°/s velocity. Subjects were instructed to actively reproduce this criterion angle and to stop knee motion, via a thumb switch. No feedback was provided.
3 secondary outcomes
The Lysholm scale
Time frame: 4 weeks
The Tegner scale
Time frame: 4 weeks
VAS scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 35438677Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.
- Individual participant dataSharing planned: No
Related trials for ACL Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized physiotherapy program and Kinesio tape in people with ACL Rupture and Rehabilitation, run by Lithuanian Sports University at 1 site in Lithuania.
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 1 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: finished, as of the sponsor's last update on 8 Jul 2021. 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 Lithuania. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static and dynamic balance (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT04954924, which also lists 1 linked publication.
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 8 Jul 2021.