Mental Imagery to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study

March 5, 2025 updated by: Marquette University

Mental Imagery of Open and Closed Chain Exercises to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study

The goal of this clinical trial is to understand if people recovering from anterior cruciate ligament reconstruction (ACLR) surgery will complete mental imagery training and if this will improve their injured leg's strength. The main questions are:

  • Will people complete a five-day mental imagery exercise schedule while in physical therapy for ACLR?
  • Does mental imagery exercise help raise leg strength during ACLR recovery? Researchers will also compare if different mental imagery exercises involving leg extension or squats will change leg strength.

Participants will be asked to:

  • Participate in two testing sessions to make measurements of leg function
  • Complete about 10 minutes of mental imagery exercises once per day for five days at home and write down whether they complete the exercises.

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 (Estimated)

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.
20

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

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Marquette University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • post anterior cruciate ligament reconstruction (ACLR) surgery
  • cleared to participate in physical therapy
  • currently in physical therapy related to ACLR

Exclusion Criteria:

  • greater than 9 months post ACLR surgery
  • history of lower back of hip pain that would limit lower limb motor testing
  • current neurological condition that limits muscle strength
  • history of substance abuse in the last 5 years
  • any uncontrolled medical condition
  • inability to follow 2-step commands

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Mental Imagery Open Chain
Participants will receive a paper packet with instructions to imagine themselves performing seated maximal leg extension exercises. They will be instructed to imagine the feeling of the exercise for 5 seconds, rest for 5 seconds, and repeat this 50 times with a 2-minute rest period after the 25th repetition. They will also be asked to keep track of the exercises with tallies on a table within the packet and also to record on this table if they did not complete the exercises for that day. The participant is asked to perform the exercises on five consecutive days.
Behavioral: Mental Imagery Open Chain
Participants will receive a paper packet with instructions to imagine themselves performing seated maximal leg extension exercises. They will be instructed to imagine the feeling of the exercise for 5 seconds, rest for 5 seconds, and repeat this 50 times with a 2-minute rest period after the 25th repetition. They will also be asked to keep track of the exercises with tallies on a table within the packet and also to record on this table if they did not complete the exercises for that day. The participant is asked to perform the exercises on five consecutive days.
Experimental: Mental Imagery Closed Chain
Participants will receive a paper packet with instructions to imagine themselves performing maximal standing squat exercises. They will be instructed to imagine the feeling of the exercise for 5 seconds, rest for 5 seconds, and repeat this 50 times with a 2-minute rest period after the 25th repetition. They will also be asked to keep track of the exercises with tallies on a table within the packet and also to record on this table if they did not complete the exercises for that day. The participant is asked to perform the exercises on five consecutive days.
Behavioral: Mental Imagery Closed Chain
Participants will receive a paper packet with instructions to imagine themselves performing maximal standing squat exercises. They will be instructed to imagine the feeling of the exercise for 5 seconds, rest for 5 seconds, and repeat this 50 times with a 2-minute rest period after the 25th repetition. They will also be asked to keep track of the exercises with tallies on a table within the packet and also to record on this table if they did not complete the exercises for that day. The participant is asked to perform the exercises on five consecutive days.

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
Feasibility of Intervention
Time Frame: Once per day for 5 days
At the end of the paper packet with instructions for mental imagery exercises, there will be a survey in which participants will record whether or not they have completed the exercises. They will be instructed to fill out this form each day even if they have not done the exercise. Investigators will assess how many days participants complete the exercises.
Once per day for 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee Extension Strength
Time Frame: Pre and post 5 days of mental imagery intervention
Maximal voluntary isometric contractions (MVICs) of the knee extensors will be conducted while the participant is seated in a Biodex Dynamometer and secured with waist and trunk straps. This will involve the participant kicking as hard as they can over 2-5 seconds. Participants will be verbally encouraged to achieve maximal force, and they will be able to see a monitor with visual instruction. Participants will be provided at least 60 seconds of rest between trials, and 5 trials will be performed. If the fifth trial produces a force more than 5% greater than any other trial, additional trials may be performed.
Pre and post 5 days of mental imagery intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: Pre and post 5 days of mental imagery intervention
Participants will be asked to complete the Ten Meter Walk Test which assesses self-selected and fast walking speed over the middle 6 meters of a 10-meter distance. They will walk at their self-selected and fast walking speed 3 times each over the 10-meter distance, and average speeds will be calculated.
Pre and post 5 days of mental imagery intervention
Knee range of motion
Time Frame: Pre and post 5 days of mental imagery intervention
Active and passive range of motion for knee extension and flexion.
Pre and post 5 days of mental imagery intervention

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.
Marquette 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 14, 2025

Primary Completion (Estimated)

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.
January 28, 2026

Study Completion (Estimated)

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.
January 28, 2026

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 27, 2025

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 27, 2025

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.
March 25, 2025

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 25, 2025

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 5, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

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.
  • HR-4875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The investigators in this study plan to publish future findings in scientific journals and/or presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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