Spinal Cord Injury/DisorderNCT07768761
Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis
A study testing Exercise with Electrical Stimulation in people with Spinal Cord Injury/Disorder and Stroke, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury/Disorder, Stroke, Multiple Sclerosis
- What is being tested?
- Exercise with Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 19 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower limb paralysis due to SCI or other neurological disorder
- Greater than 18 years of age
- Innervated and excitable lower extremity muscles
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
Maura Malenchek, PTA, 216-791-3800 ext. 64989, maura.malenchek@va.gov
Lisa Lombardo, MPT, 216-791-3800 ext. 64909, lisa.lombardo2@va.gov
About this study
Official title: 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.
- Being tested
- Exercise with Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries, Stroke, Multiple Sclerosis, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with Electrical StimulationOther
Also called Electrical Stimulation, Exercise
Neuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Electrical stimulation exercise for three different exercise modalities. Exercise training will consist of 24-36 sessions 2-3 times per week. Receives: Other: Exercise with Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Time
Amount of time in minutes an individual is able to continuously exercise
Measured: At enrollment and end of treatment at 18 weeks or 36 sessions.
Electrically Stimulated Muscle Strength
Electrically stimulated knee extension strength in Newton-meters
Measured: At enrollment and end of treatment at 18 weeks or 36 sessions.
Secondary outcomes (1)
Exercise Power
Average power in watts produced during exercise
Measured: At enrollment and end of treatment at 18 weeks or 36 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start19 Jan 2018
- Primary completion19 Jan 2031 (estimated)
- Study completion19 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury/DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Clifford Eric Heidorn, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768761
- Sponsor's protocol ID
- 1583821/ 17043-H33
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electrical Stimulation Exercise Training for Those With Lower Limb Paralysis
- ClinicalTrials.gov ID
- NCT07768761
- Acronym / sponsor ID
- 1583821/ 17043-H33
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 19 Jan 2031 (estimated)
- Study completion
- 19 Jan 2031 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Exercise with Electrical StimulationElectrical stimulation exercise for three different exercise modalities. Exercise training will consist of 24-36 sessions 2-3 times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lower limb paralysis due to SCI or other neurological disorder
- Greater than 18 years of age
- Innervated and excitable lower extremity muscles
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with Electrical StimulationAlso: Electrical Stimulation, ExerciseNeuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer). | Other | Exercise Intervention |
Primary outcome
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
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
1 secondary outcome
Exercise Power
Time frame: At enrollment and end of treatment at 18 weeks or 36 sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with Electrical Stimulation in people with Spinal Cord Injury/Disorder and Stroke, run by Louis Stokes VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maura Malenchek, PTA (216-791-3800 ext. 64989, maura.malenchek@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Time (time frame: At enrollment and end of treatment at 18 weeks or 36 sessions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.