- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954924
Effect of Kinesio Tape on Motor Function in Subjects With ACL Rupture
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania, 44221
- Lithuanian Sports University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 - 35-year-old men;
- a normal contralateral knee,
- not a longer period than 3 months after ACL rupture.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group - standardized physiotherapy program
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.
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Experimental: Experimental group - standardized physiotherapy program and Kinesio tape
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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4 weeks
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Muscle torque
Time Frame: 4 weeks
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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).
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4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Lysholm scale
Time Frame: 4 weeks
|
The Lysholm scale does measure the domains of symptoms and complaints and does measure functioning in daily activities
|
4 weeks
|
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The Tegner scale
Time Frame: 4 weeks
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The Tegner scale measure the subjective functional activity
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4 weeks
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VAS scale
Time Frame: 4 weeks
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The severity of pain was determined based on a numerical pain scale in which 0 symbolizes 'no pain' and 10 symbolizes 'maximum pain'
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuananianSportsU-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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