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Short Term Immobilization of the Lower Limb (STILL)

Primary Purpose

Weakness, Muscle, Muscle Weakness, Muscle Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Action Observation + Mental Imagery
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weakness, Muscle focused on measuring immobilization, muscle atrophy, muscle strength, action observation, mental imagery, neuromuscular electrical stimulation, rehabilitation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Central Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immobilization

Control

Arm Description

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

The control group will not undergo any intervention.

Outcomes

Primary Outcome Measures

Muscular strength
Changes in muscular strength will be measured via maximal voluntary contraction torque
Muscular size
Changes in muscular size will be measured via ultrasonography of the quadriceps
Corticospinal responses
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
Motor unit behavior
Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
Voluntary activation
Voluntary activation will be measured using the interpolated twitch technique
Rate of recovery
The time taken to recover strength lost will be measured via number of resistance training sessions needed after immobilization

Secondary Outcome Measures

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.
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

Full Information

First Posted
September 28, 2021
Last Updated
August 17, 2022
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05072652
Brief Title
Short Term Immobilization of the Lower Limb
Acronym
STILL
Official Title
Short-term Immobilization and Rehabilitation of the Lower Limb: Changes in Strength, Size, and Neuromuscular Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weakness, Muscle, Muscle Weakness, Muscle Loss, Muscle Atrophy, Injury, Knee
Keywords
immobilization, muscle atrophy, muscle strength, action observation, mental imagery, neuromuscular electrical stimulation, rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Repeated measures design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immobilization
Arm Type
Experimental
Arm Description
Participants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not undergo any intervention.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
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
Intervention Name(s)
Action Observation + Mental Imagery
Intervention Description
Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.
Primary Outcome Measure Information:
Title
Muscular strength
Description
Changes in muscular strength will be measured via maximal voluntary contraction torque
Time Frame
15 minutes
Title
Muscular size
Description
Changes in muscular size will be measured via ultrasonography of the quadriceps
Time Frame
10 minutes
Title
Corticospinal responses
Description
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
Time Frame
30 minutes
Title
Motor unit behavior
Description
Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
Time Frame
10 minutes
Title
Voluntary activation
Description
Voluntary activation will be measured using the interpolated twitch technique
Time Frame
15 minutes
Title
Rate of recovery
Description
The time taken to recover strength lost will be measured via number of resistance training sessions needed after immobilization
Time Frame
1.5 hours per session
Secondary Outcome Measure Information:
Title
Compliance
Description
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.
Time Frame
one week
Title
Physical activity (Step count)
Description
Physical activity will be assessed via step counts and compared to changes in primary outcome measures via accelerometers around both ankles
Time Frame
one week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants enrolled in this study must self identify with their biological sex at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt S Stock, PhD
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be made available upon reasonable request after the time of study completion and manuscript publication
IPD Sharing Access Criteria
To access IPD, please contact the study PI.
Links:
URL
https://healthprofessions.ucf.edu/research/studies/
Description
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Short Term Immobilization of the Lower Limb

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