Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis

August 14, 2026 updated by: Clifford Eric Heidorn, Louis Stokes VA Medical Center

Efficacy of Electrical Stimulation Exercise Training for Those 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes Cleveland VA Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • C. Eric Heidorn, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention
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
Neuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).
Other Names:
  • Exercise
  • Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Electrically stimulated knee extension strength in Newton-meters
At enrollment and end of treatment at 18 weeks or 36 sessions.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Power
Time Frame: At enrollment and end of treatment at 18 weeks or 36 sessions.
Average power in watts produced during exercise
At enrollment and end of treatment at 18 weeks or 36 sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Stokes VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2018

Primary Completion (Estimated)

January 19, 2031

Study Completion (Estimated)

January 19, 2031

Study Registration Dates

First Submitted

August 3, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1583821/ 17043-H33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe