NCT04954924

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2015

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • The Lysholm scale

    4 weeks

  • The Tegner scale

    4 weeks

  • VAS scale

    4 weeks

Study Arms (2)

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.

Other: standardized physiotherapy program and Kinesio tape

Interventions

Experimental group - standardized physiotherapy program and Kinesio tape

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • year-old men;
  • a normal contralateral knee,
  • not a longer period than 3 months after ACL rupture.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports University

Kaunas, 44221, Lithuania

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

February 1, 2010

Primary Completion

January 15, 2015

Study Completion

January 15, 2015

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations