Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis

NCT07768761 | Recruiting

• 1 other identifier: 1583821/ 17043-H33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Exercise Time

  Amount of time in minutes an individual is able to continuously exercise

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

• Electrically Stimulated Muscle Strength

  Electrically stimulated knee extension strength in Newton-meters

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

Secondary Outcomes (1)

• Exercise Power

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

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Electrical stimulation exercise for three different exercise modalities. Exercise training will consist of 24-36 sessions 2-3 times per week.

Other: Exercise with Electrical Stimulation

Interventions

Exercise with Electrical Stimulation OTHER

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

Also known as: Electrical Stimulation, Exercise

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower limb paralysis due to SCI or other neurological disorder
• Greater than 18 years of age
• Innervated and excitable lower extremity muscles

You may not qualify if:

• 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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Multiple Sclerosis; Brain Injuries, Traumatic

Interventions

Exercise; Electric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Brain Injuries; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Stimulation; Investigative Techniques

Central Study Contacts

Maura Malenchek, PTA

CONTACT

216-791-3800; maura.malenchek@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 17, 2026
• Study Start: January 19, 2018
• Primary Completion (Estimated): January 19, 2031
• Study Completion (Estimated): January 19, 2031
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

US (1)