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Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis

Efficacy of Electrical Stimulation Exercise Training for Those With Lower Limb Paralysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07768761
Enrollment
60
Registered
2026-08-17
Start date
2018-01-19
Completion date
2031-01-19
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Spinal Cord Injury/Disorder, Stroke, Traumatic Brain Injury

Brief summary

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

OTHERExercise with Electrical Stimulation

Neuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).

Sponsors

Louis Stokes VA Medical Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise TimeAt 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 StrengthAt enrollment and end of treatment at 18 weeks or 36 sessions.Electrically stimulated knee extension strength in Newton-meters

Secondary

MeasureTime frameDescription
Exercise PowerAt enrollment and end of treatment at 18 weeks or 36 sessions.Average power in watts produced during exercise

Countries

United States

Contacts

CONTACTMaura Malenchek, PTA
maura.malenchek@va.gov216-791-3800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026