NCT01170546

Brief Summary

Question: To investigate how different modes of thigh muscles strengthening exercises emphasizing the knee internal rotators can be as effective as possible in improving the static stability and agility of the knees with anterior drawer laxity. Design: Randomized controlled clinical trial. Participants and Interventions: Young men with anterior drawer laxity of the knee were randomly assigned to three experimental groups in different strengthening modes: plate-loaded squat press (SP), plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC). The control group with stable knees received no training. Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of this paper was to find out an optimal solution to the enhancement of the static and dynamic knee stability to a great extent. Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal rotator

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1 month until next milestone

Results Posted

Study results publicly available

September 6, 2010

Completed
Last Updated

November 23, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

July 23, 2010

Results QC Date

August 2, 2010

Last Update Submit

November 15, 2010

Conditions

Keywords

anterior cruciate ligamentagilityknee stabilityhamstringknee internal rotator

Outcome Measures

Primary Outcomes (4)

  • Static Knee Stability

    The KT-2000 knee ligament arthrometer (MED Metric Co., San Diego, USA) is designed to assess the anterior drawer laxity of the knee joint. The discrepancy of anterior displacement between the sound side and the lesion side is applied in evaluating the static stability of the knee.

    one year

  • Agility

    shuttle run agility test

    one year

  • Isokinetic Strength

    Cybex NORM (Cybex International, Inc, Ronkonkoma, New York, U.S.A.) was employed to evaluate isokinetic muscle strength before and after training.

    one year

  • Age

    before training

Study Arms (3)

KLCIR

EXPERIMENTAL

plate-loaded kneeling leg curl with internal rotation

Other: plate-loaded kneeling leg curl with internal rotation

SP (Squat Press)

EXPERIMENTAL

plate-loaded squat press

Other: plate-loaded squat press

KLC (Kneeling Leg Curl)

EXPERIMENTAL

plate-loaded kneeling leg curl

Other: plate-loaded kneeling leg curl

Interventions

The participant was instructed to point toes toward medial side as knee flexing. This is an open-kinetic chain (OKC) exercise and medial hamstring was emphasized.

KLCIR

The subject was instructed to position his back properly against the backrest on a machine, with the feet slightly apart. He was instructed to place his feet higher on the foot plate and draw his two knees as close as possible while the knees flexed so that medial hamstring would supposedly bear more tension in the course of knee flexion. This is a closed-kinetic chain (CKC) exercise and was expected to strengthen the quadriceps and hamstring with medial hamstring emphasized.

Also known as: angled leg presses
SP (Squat Press)

An open-kinetic chain (OKC) exercise was intended to strengthen the hamstring muscle without lateralization emphasized.

KLC (Kneeling Leg Curl)

Eligibility Criteria

Age15 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The anterior drawer laxity of the knee joint in this study was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.

You may not qualify if:

  • anterior displacement less than 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital

Taipei, Taiwan, Taiwan

Location

Limitations and Caveats

small size, participant: not real ACL-injured patient but knee with anterior laxity instead

Results Point of Contact

Title
Shih-Wei Chou, MD, PhD
Organization
Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital

Study Officials

  • Shih-Wei Chou

    Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 27, 2010

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

April 1, 2007

Last Updated

November 23, 2010

Results First Posted

September 6, 2010

Record last verified: 2010-09

Locations