Short Term Immobilization of the Lower Limb

NCT ID: NCT05072652

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2022-07-01

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Repeated measures design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immobilization

Participants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type OTHER

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

Intervention Type OTHER

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

Control

The control group will not undergo any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Action Observation + Mental Imagery

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Matt Stock

Associate Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matt S Stock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38687158 (View on PubMed)

Related Links

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Other Identifiers

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00003289

Identifier Type: -

Identifier Source: org_study_id

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