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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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