Knee vs. Ankle Training on Knee Mechanics After ACLR

March 16, 2022 updated by: Mohamed Magdy Ali Hassan ElMeligie, October 6 University

Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

This study will be conducted to investigate if there is any difference between starting rehabilitation program after ACL reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

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

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 12511
        • Recruiting
        • October 6 University Hospital
        • Contact:

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

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • ACL reconstruction with a hamstring tendon autograft participated in this study.
  • Score 7 on Tegner activity scale.

Exclusion Criteria:

  • Patients with bilateral knee injury
  • History of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity
  • History of ACL reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A: Knee exercises then Ankle exercises
Patients will receive a rehabilitation protocol starting with knee training followed by ankle training.
Other: Knee then Ankle rehabilitation protocol

Patients will start with knee exercise program that includes

  • Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.
  • Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.
  • Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.
  • Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.

Then, Patients will start ankle exercises program that includes:

  • Standing calf raises
  • Foot lift
  • Ankle eversion exercises
  • Ankle Plantarflexion exercises
EXPERIMENTAL: Group B: Ankle exercises then Knee exercises
Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.
Other: Ankle then Knee rehabilitation protocol

Patients will start ankle exercises program that includes:

  • Standing calf raises
  • Foot lift
  • Ankle eversion exercises
  • Ankle Plantarflexion exercises

Then, Patients will start with knee exercise program that includes

  • Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.
  • Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.
  • Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.
  • Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Time Frame: baseline and 6 weeks posttreatment
Knee joint flexion torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
baseline and 6 weeks posttreatment
Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Time Frame: baseline and 6 weeks posttreatment
Knee joint extension torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
baseline and 6 weeks posttreatment

Collaborators and Investigators

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

Sponsor

October 6 University

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 (ACTUAL)

February 13, 2022

Primary Completion (ANTICIPATED)

July 21, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

February 5, 2022

First Submitted That Met QC Criteria

February 5, 2022

First Posted (ACTUAL)

February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACL2122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant data will be shared

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

personal email: mohamed.magdy.pt@o6u.edu.eg

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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