Short Term Immobilization of the Lower Limb (STILL)

August 17, 2022 updated by: Matt Stock, University of Central Florida

Short-term Immobilization and Rehabilitation of the Lower Limb: Changes in Strength, Size, and Neuromuscular Function

The purpose of this study is to determine the effects of one week of knee-joint immobilization on muscle size, strength, neuromuscular function, and brain function. In addition, the effects of two different interventions (i.e., neuromuscular electrical stimulation and action observation/mental imagery) throughout immobilization will be determined. Following the immobilization period, participants that have lost strength will be rehabilitated with twice weekly resistance training sessions, and sex-based differences in rehabilitation timelines will be examined.

Study Overview

Status

Status

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

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.

Detailed Description

This study will utilize a repeated measures design in healthy adults aged 18-40 years. After a thorough familiarization visit, muscular size, strength, neuromuscular responses, and corticospinal excitability/inhibition will be measured before (PRE) and after (POST) one week of unilateral knee joint immobilization of the left leg. Four groups will be examined: 1) immobilization only, 2) immobilization + daily neuromuscular electrical stimulation, 3) immobilization + daily action observation/mental imagery training, 4) a control group. Throughout the immobilization period, participants will be in a leg brace locked at 90 degrees knee flexion. They will perform daily range of motion exercises and wear a compression sock at all times to mitigate the risk of blood clots. Following completion of the immobilization period, participants that have lost strength will complete a supervised rehabilitation program of twice weekly lower body resistance training sessions until they have returned to baseline levels of strength. Group assignment will be randomized and blocked on sex to ensure an equal number of participants within each group consisting of a relatively equal number of males and females.

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 (Actual)

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.
50

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 Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32816
        • University of Central Florida

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women between the ages of 18-40 years
  • Body mass index >20 kg/m2 or < 35 kg/m2

Exclusion Criteria:

  • Body mass index <20 kg/m2 or > 35 c
  • Experience of major joint pain/discomfort of the upper or lower limbs, back, or neck within the previous six months.
  • History of major musculoskeletal injury or surgery
  • Neuromuscular disease (e.g., Parkinson's, MS, ALS)
  • Metabolic disease (e.g., diabetes, thyroid disorder, metabolic syndrome)
  • Personal or family history of blood clots
  • Trouble using or controlling one's muscles
  • History of cancer
  • History of stroke
  • History of heart attack
  • History of arthritis
  • Use of an assistive walking device or mobility aids within the past six months
  • Use of anabolic steroids within the past six months
  • History of convulsions, seizures, or syncope
  • History of concussion as diagnosed by a physician
  • Certain medications (e.g., muscle relaxants, benzodiazepines)
  • Very thick hair or certain hairstyles that would impede the TMS coil from making direct contact with the scalp
  • Allergy to rubbing alcohol
  • Lack of transportation to and from the laboratory
  • Implant of any kind
  • Pregnancy
  • Allergy to silver
  • Diagnosis of any psychiatric condition

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: Prevention
  • 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: Immobilization
Participants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg.
Other: Neuromuscular Electrical Stimulation
Participants in this group will perform twice daily neuromuscular electrical stimulation training sessions of the quadriceps muscles (specifically, the vastus lateralis and rectus femoris) or the immobilized left leg.
Other: Action Observation + Mental Imagery
Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.
No Intervention: Control
The control group will not undergo any intervention.

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
Muscular strength
Time Frame: 15 minutes
Changes in muscular strength will be measured via maximal voluntary contraction torque
15 minutes
Muscular size
Time Frame: 10 minutes
Changes in muscular size will be measured via ultrasonography of the quadriceps
10 minutes
Corticospinal responses
Time Frame: 30 minutes
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
30 minutes
Motor unit behavior
Time Frame: 10 minutes
Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
10 minutes
Voluntary activation
Time Frame: 15 minutes
Voluntary activation will be measured using the interpolated twitch technique
15 minutes
Rate of recovery
Time Frame: 1.5 hours per session
The time taken to recover strength lost will be measured via number of resistance training sessions needed after immobilization
1.5 hours per session

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
Compliance
Time Frame: one week
Compliance will be measured via the use of accelerometers around both ankles. Compliance will be calculated as the number of participants that following the crutch/brace protocol as described.
one week
Physical activity (Step count)
Time Frame: one week
Physical activity will be assessed via step counts and compared to changes in primary outcome measures via accelerometers around both ankles
one week

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.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matt S Stock, PhD, University of Central Florida

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.

Helpful Links

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.
October 11, 2021

Primary Completion (Actual)

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.
June 1, 2022

Study Completion (Actual)

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.
July 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).
September 28, 2021

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.
September 28, 2021

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.
October 11, 2021

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.
August 19, 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.
August 17, 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.
August 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 00003289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared by the PI upon reasonable request. Personal identifiable information will not be shared; however, physiological data and outcome measures may be shared if requested.

IPD Sharing Time Frame

Data will be made available upon reasonable request after the time of study completion and manuscript publication

IPD Sharing Access Criteria

To access IPD, please contact the study PI.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

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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