Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLouis Stokes VA Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lower limb paralysis due to SCI or other neurological disorder
Greater than 18 years of age
Innervated and excitable lower extremity muscles
Disqualifiers
Females that are pregnant
Ventilator dependent
Current pressure injuries that would be exacerbated by exercise
History of spontaneous fractures
Trial design
Design model
Single group
Treatments tested in this trial
Exercise with Electrical Stimulation
Other interventionNeuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Exercise InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Exercise Time
Amount of time in minutes an individual is able to continuously exercise
Time frame
At enrollment and end of treatment at 18 weeks or 36 sessions.2
Electrically Stimulated Muscle Strength
Electrically stimulated knee extension strength in Newton-meters
Time frame
At enrollment and end of treatment at 18 weeks or 36 sessions.Secondary outcomes
1
Exercise Power
Average power in watts produced during exercise
Time frame
At enrollment and end of treatment at 18 weeks or 36 sessions.Sponsors and contacts
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Source ClinicalTrials.gov