Muscle Weakness Clinical Trial
— STILLOfficial title:
Short-term Immobilization and Rehabilitation of the Lower Limb: Changes in Strength, Size, and Neuromuscular Function
NCT number | NCT05072652 |
Other study ID # | 00003289 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2021 |
Est. completion date | July 1, 2022 |
Verified date | August 2022 |
Source | University of Central Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Central Florida | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Central Florida |
United States,
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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