Weakness, MuscleSTILLNCT05072652
Short Term Immobilization of the Lower Limb
A study testing Neuromuscular Electrical Stimulation and Action Observation + Mental Imagery in people with Weakness, Muscle and Muscle Weakness, run by University of Central Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Weakness, Muscle, Muscle Weakness, Muscle Loss
- What is being tested?
- Neuromuscular Electrical Stimulation and Action Observation + Mental Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between the ages of 18-40 years
- Body mass index >20 kg/m2 or < 35 kg/m2
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: 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.
Read the 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.
- Conditions
- Weakness, Muscle, Muscle Weakness, Muscle Loss, Muscle Atrophy, Injury, Knee
- Being tested
- Neuromuscular Electrical Stimulation, Action Observation + Mental Imagery
- Keywords
- immobilization, muscle atrophy, muscle strength, action observation, mental imagery, neuromuscular electrical stimulation, rehabilitation
- Medical subject headings
- Muscle Weakness, Muscular Atrophy, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
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.
Action Observation + Mental ImageryOther
Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization | Experimental | Participants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg. Receives: Other: Neuromuscular Electrical Stimulation; Other: Action Observation + Mental Imagery |
| Control | No intervention | The control group will not undergo any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Changes in muscular strength will be measured via maximal voluntary contraction torque
Measured: 15 minutes
Muscular size
Changes in muscular size will be measured via ultrasonography of the quadriceps
Measured: 10 minutes
Corticospinal responses
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
Measured: 30 minutes
Motor unit behavior
Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
Measured: 10 minutes
Voluntary activation
Voluntary activation will be measured using the interpolated twitch technique
Measured: 15 minutes
Rate of recovery
The time taken to recover strength lost will be measured via number of resistance training sessions needed after immobilization
Measured: 1.5 hours per session
Secondary outcomes (2)
Compliance
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.
Measured: one week
Physical activity (Step count)
Physical activity will be assessed via step counts and compared to changes in primary outcome measures via accelerometers around both ankles
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start11 Oct 2021
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weakness, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated measures design
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Stock, University of Central Florida
- Investigators
- Matt S Stock, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072652
- Sponsor's protocol ID
- 00003289
- Acronym
- STILL
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Harmon KK, Girts RM, Rodriguez G, Beausejour JP, Pagan JI, Carr JC, Garcia J, Roberts MD, Hahs-Vaughn DL, Stout JR, Fukuda DH, Stock MS. Combined action observation and mental imagery versus neuromuscular electrical stimulation as novel therapeutics during short-term knee immobilization. Exp Physiol. 2024 Jul;109(7):1145-1162. doi: 10.1113/EP091827. Epub 2024 Apr 30.
PubMed 38687158
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Immobilization and Rehabilitation of the Lower Limb: Changes in Strength, Size, and Neuromuscular Function
- ClinicalTrials.gov ID
- NCT05072652
- Acronym / sponsor ID
- STILL / 00003289
- Conditions
- Weakness, Muscle, Muscle Weakness, Muscle Loss, Muscle Atrophy, Injury, Knee
- Keywords
- immobilization, muscle atrophy, muscle strength, action observation, mental imagery, neuromuscular electrical stimulation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Immobilization | Experimental | Other: Neuromuscular Electrical Stimulation, Other: Action Observation + Mental ImageryParticipants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg. |
| Control | No intervention | –The control group will not undergo any intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women between the ages of 18-40 years
- Body mass index >20 kg/m2 or < 35 kg/m2
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulationParticipants 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 | Immobilization |
| Action Observation + Mental ImageryParticipants in this group will perform daily action observation + mental imagery training via video and audio recordings. | Other | Immobilization |
Primary outcome
Muscular strength
Time frame: 15 minutes
Changes in muscular strength will be measured via maximal voluntary contraction torque
Muscular size
Time frame: 10 minutes
Changes in muscular size will be measured via ultrasonography of the quadriceps
Corticospinal responses
Time frame: 30 minutes
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
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
Voluntary activation
Time frame: 15 minutes
Voluntary activation will be measured using the interpolated twitch technique
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
2 secondary outcomes
Compliance
Time frame: one week
Physical activity (Step count)
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 38687158Harmon KK, Girts RM, Rodriguez G, Beausejour JP, Pagan JI, Carr JC, Garcia J, Roberts MD, Hahs-Vaughn DL, Stout JR, Fukuda DH, Stock MS. Combined action observation and mental imagery versus neuromuscular electrical stimulation as novel therapeutics during short-term knee immobilization. Exp Physiol. 2024 Jul;109(7):1145-1162. doi: 10.1113/EP091827. Epub 2024 Apr 30.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt S Stock, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and Action Observation + Mental Imagery in people with Weakness, Muscle and Muscle Weakness, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength (time frame: 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.