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NCT Number: NCT07768761

Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis

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.

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Key information

Conditions

Spinal Cord Injury/Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise with Electrical Stimulation

Other

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

Other names: Electrical Stimulation, Exercise

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Exercise Power

    Time frame: At enrollment and end of treatment at 18 weeks or 36 sessions.

    Average power in watts produced during exercise

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Louis Stokes VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2031
Study completion
2031
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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