Short Term Immobilization of the Lower Limb

Muscle Weakness Clinical Trial

— STILL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072652
• Other study ID #: 00003289
• Status: Completed
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Atrophy
• Injury, Knee
• Knee Injuries
• Muscle Atrophy
• Muscle Loss
• Muscle Weakness
• Muscular Atrophy
• Weakness, Muscle

Intervention

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.
• Action Observation + Mental Imagery
Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular strength	Changes in muscular strength will be measured via maximal voluntary contraction torque	15 minutes
Primary	Muscular size	Changes in muscular size will be measured via ultrasonography of the quadriceps	10 minutes
Primary	Corticospinal responses	Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs	30 minutes
Primary	Motor unit behavior	Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps	10 minutes
Primary	Voluntary activation	Voluntary activation will be measured using the interpolated twitch technique	15 minutes
Primary	Rate of recovery	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	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.	one week
Secondary	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	one week

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