NCT07768761 · Louis Stokes VA Medical Center
Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis
What this study is about
The purpose of this research study is to evaluate the effectiveness of an exercise training intervention (24-36 sessions) to improve muscle strength and endurance in the lower limbs of individuals with paralysis.
View original scientific description
The purpose of this research study is to evaluate the effectiveness of an exercise training intervention (24-36 sessions) to improve muscle strength and endurance in the lower limbs of individuals with paralysis. Specifically, surface electrical stimulation or previously implanted stimulator will be used to stimulate the muscles during various forms of exercise training with the primary focus on improving overall endurance and maximal power output. For this study, peripheral stimulating electrodes will send electrical signals to the muscles enabling the production of coordinated movements for exercise such as cycling or rowing.
Interventions
OTHER
Exercise with Electrical Stimulation
Neuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).
Primary outcome measures
Exercise Time
Time frame: At enrollment and end of treatment at 18 weeks or 36 sessions.
Amount of time in minutes an individual is able to continuously exercise
Electrically Stimulated Muscle Strength
Time frame: At enrollment and end of treatment at 18 weeks or 36 sessions.
Electrically stimulated knee extension strength in Newton-meters
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Lower limb paralysis due to SCI or other neurological disorder
- Greater than 18 years of age
- Innervated and excitable lower extremity muscles
Exclusion criteria
- Females that are pregnant
- Ventilator dependent
- Current pressure injuries that would be exacerbated by exercise
- History of spontaneous fractures
- Cardiovascular or pulmonary disease that would limit the ability to exercise
- Uncontrolled diabetes or hypertension
- Large body frame that would prevent participant from comfortably fitting the exercise equipment
- Any other medical or psychological condition that would be a contraindication to participating in an exercise program
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations