Recruiting

Exercise Training

Sponsor:

Louis Stokes VA Medical Center

Code:

NCT07768761

Conditions

Spinal Cord Injury/Disorder

Stroke

Multiple Sclerosis

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise with Electrical Stimulation

Study Details

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

Study ID

NCT07768761

Start date

Jan 19, 2018

Status verified date

Aug, 2026

Completion date

Jan 19, 2031

Anticipated

Primary completion date

Jan 19, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

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

Interventions

Exercise with Electrical Stimulation

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

Primary outcome measure

  • Exercise Time [ Time Frame: At enrollment and end of treatment at 18 weeks or 36 sessions. ]
  • Electrically Stimulated Muscle Strength [ Time Frame: At enrollment and end of treatment at 18 weeks or 36 sessions. ]

Central Contacts and Locations

Central contacts

Maura Malenchek, PTA

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

Locations

Louis Stokes Cleveland VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Maura Malenchek, PTA

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

Lisa Lombardo, MPT

216-791-3800lisa.lombardo2@va.gov

Principal Investigator:

C. Eric Heidorn, PhD

More Information

Sponsor

Louis Stokes VA Medical Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Stokes VA Medical Center on 2026-08-17.