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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04954924
Other study ID # LithuananianSportsU-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2010
Est. completion date January 15, 2015

Study information

Verified date June 2021
Source Lithuanian Sports University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 15, 2015
Est. primary completion date January 15, 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. 18 - 35-year-old men; 2. a normal contralateral knee, 3. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
standardized physiotherapy program and Kinesio tape


Locations

Country Name City State
Lithuania Lithuanian Sports University Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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). 4 weeks
Primary 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. 4 weeks
Secondary The Lysholm scale The Lysholm scale does measure the domains of symptoms and complaints and does measure functioning in daily activities 4 weeks
Secondary The Tegner scale The Tegner scale measure the subjective functional activity 4 weeks
Secondary 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' 4 weeks
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