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Short Term Immobilization of the Lower Limb (STILL)

University of Central Florida logo

University of Central Florida

Status

Completed

Conditions

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

Treatments

Other: Action Observation + Mental Imagery
Other: Neuromuscular Electrical Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05072652
00003289

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Immobilization
Experimental group
Description:
Participants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg.
Treatment:
Other: Neuromuscular Electrical Stimulation
Other: Action Observation + Mental Imagery
Control
No Intervention group
Description:
The control group will not undergo any intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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