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RecruitingNCT07768761Updated Aug 17, 2026

Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis

An interventional study of Exercise with Electrical Stimulation in Spinal Cord Injury/Disorder, Stroke and Multiple Sclerosis, sponsored by Louis Stokes VA Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Louis Stokes VA Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 6 months after the study started (first participant enrolled Jan 2018, registered Aug 2026).
  • Started Jan 2018; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Spinal Cord Injury/Disorder
  • Stroke
  • Multiple Sclerosis
  • Traumatic Brain Injury
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 60 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Louis Stokes VA Medical Center is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to participating in an exercise program
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study 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.

    Other: Exercise with Electrical Stimulation

Interventions

  • OtherExercise with Electrical Stimulation

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

    Also known as: Electrical Stimulation, Exercise

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What researchers measure

Primary outcomes

  1. Exercise Time

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

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

  2. Electrically Stimulated Muscle Strength

    Electrically stimulated knee extension strength in Newton-meters

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

Secondary outcomes

  1. Exercise Power

    Average power in watts produced during exercise

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

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Study locations

1 of 1 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Jan 2031, 156 months after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 156 months is above that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 17, 2026
StartActual
Jan 19, 2018
Primary completionEst.
Jan 19, 2031
CompletionEst.
Jan 19, 2031
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07768761
Lead sponsor
Louis Stokes VA Medical Center
Responsible party
Clifford Eric Heidorn (Primary Investigator, Louis Stokes VA Medical Center) — Principal investigator
First posted
Aug 17, 2026
Start date
Jan 19, 2018
Primary completion
Jan 19, 2031 (estimated)
Completion
Jan 19, 2031 (estimated)
Last update
Aug 17, 2026

Study contacts

Maura Malenchek, PTA
Contact
maura.malenchek@va.gov
216-791-3800 ext. 64989

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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