Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction

December 18, 2023 updated by: Schulthess Klinik

Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?

The main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of cross-education induced by NMES versus eccentric strength training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8008
        • Neuromuscular Research Laboratory, Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients scheduled for ACL reconstruction surgery

Exclusion Criteria:

  • Concomitant lower limb injury or disorder
  • previous lower extremity open surgery on the contralateral lower limb
  • cardiac disease
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES
neuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab
Behavioral: Neuromuscular electrical stimulation
Experimental: eccentric training
unilateral eccentric resistance exercises
Behavioral: eccentric training
Sham Comparator: sham NMES
neuromuscular electrical stimulation of the quadriceps muscle with intensity which causes no visible contraction or displacement of the leg (activation below motor threshold)
Behavioral: Neuromuscular electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bilateral quadriceps muscle strength [Nm]
Time Frame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in quadriceps muscle activation
Time Frame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle architecture
Time Frame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
Time Frame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
functional test outcomes
Time Frame: 6month postop
Assessment of present functional status by means of hop tests
6month postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Investigators

  • Principal Investigator: Nicola A Maffiuletti, PhD, Schulthess Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimated)

July 17, 2013

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Contralateral_01

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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