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Short Term Immobilization of the Lower Limb

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05072652
Acronym
STILL
Enrollment
50
Registered
2021-10-11
Start date
2021-10-11
Completion date
2022-07-01
Last updated
2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Knee, Muscle Atrophy, Muscle Loss, Muscle Weakness, Weakness, Muscle

Keywords

immobilization, muscle atrophy, muscle strength, action observation, mental imagery, neuromuscular electrical stimulation, rehabilitation

Brief 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 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.

Interventions

OTHERNeuromuscular 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.

OTHERAction Observation + Mental Imagery

Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.

Sponsors

University of Central Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Repeated measures design

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of recovery1.5 hours per sessionThe time taken to recover strength lost will be measured via number of resistance training sessions needed after immobilization
Motor unit behavior10 minutesMotor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
Voluntary activation15 minutesVoluntary activation will be measured using the interpolated twitch technique
Muscular strength15 minutesChanges in muscular strength will be measured via maximal voluntary contraction torque
Muscular size10 minutesChanges in muscular size will be measured via ultrasonography of the quadriceps
Corticospinal responses30 minutesCorticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs

Secondary

MeasureTime frameDescription
Physical activity (Step count)one weekPhysical activity will be assessed via step counts and compared to changes in primary outcome measures via accelerometers around both ankles
Complianceone weekCompliance 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026