Short Term Immobilization of the Lower Limb
STILL
Short-term Immobilization and Rehabilitation of the Lower Limb: Changes in Strength, Size, and Neuromuscular Function
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedStudy Start
First participant enrolled
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 19, 2022
August 1, 2022
8 months
September 28, 2021
August 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Muscular strength
Changes in muscular strength will be measured via maximal voluntary contraction torque
15 minutes
Muscular size
Changes in muscular size will be measured via ultrasonography of the quadriceps
10 minutes
Corticospinal responses
Corticospinal responses will be measured with transcranial magnetic stimulation targeting the lower limbs
30 minutes
Motor unit behavior
Motor unit recruitment threshold and firing rate will be measured with surface electromyography signals detected from the quadriceps
10 minutes
Voluntary activation
Voluntary activation will be measured using the interpolated twitch technique
15 minutes
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 Outcomes (2)
Compliance
one week
Physical activity (Step count)
one week
Study Arms (2)
Immobilization
EXPERIMENTALParticipants in the immobilization groups will undergo one week of unilateral knee joint immobilization of the left leg.
Control
NO INTERVENTIONThe control group will not undergo any intervention.
Interventions
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.
Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.
Eligibility Criteria
You may qualify if:
- Healthy men and women between the ages of 18-40 years
- Body mass index \>20 kg/m2 or \< 35 kg/m2
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Central Florida
Orlando, Florida, 32816, United States
Related Publications (1)
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.
PMID: 38687158DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matt S Stock, PhD
University of Central Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physical Therapy
Study Record Dates
First Submitted
September 28, 2021
First Posted
October 11, 2021
Study Start
October 11, 2021
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available upon reasonable request after the time of study completion and manuscript publication
- Access Criteria
- To access IPD, please contact the study PI.
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.