Muscle Training + Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Must not be taking: Botox, Anti-coagulation therapy
Disqualifiers: Neurologic conditions, Cancer, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using botox that affects muscle function or are on anti-coagulation therapy, you may not be eligible to participate.
What data supports the effectiveness of the treatment Downhill Eccentric Treadmill Training with Electrical Stimulation for spinal cord injury?
Research shows that combining electrical stimulation with exercises like cycling can improve muscle strength and size in people with incomplete spinal cord injuries. Additionally, regular use of electrical stimulation in home exercise programs is perceived to increase muscle bulk and endurance.
12345Is muscle training with electrical stimulation safe for people with spinal cord injuries?
Research shows that using electrical stimulation for muscle training in people with spinal cord injuries is generally safe. Studies have found it can increase muscle strength and endurance without significant safety concerns.
56789How does the treatment 'Downhill Eccentric Treadmill Training with Electrical Stimulation' differ from other treatments for spinal cord injury?
This treatment is unique because it combines downhill treadmill walking, which emphasizes muscle lengthening under tension, with electrical stimulation to enhance muscle activation and strength. This approach may offer more targeted muscle training compared to traditional methods, potentially improving muscle bulk and endurance in individuals with spinal cord injury.
56101112Eligibility Criteria
This trial is for adults aged 18-85 with spinal cord injury (SCI) within 1-5 months post-injury, discharged from inpatient rehab, and without recent surgeries or major injuries. Healthy controls of the same age range can also join if they meet similar health criteria. Participants must not have conditions like active cancer or clotting disorders, be pregnant, or have cognitive issues preventing consent.Inclusion Criteria
I had a spinal cord injury between 1-5 months ago, am aged 18-85, and have been discharged from rehab.
I am between 18-85 years old, with no recent major injuries or surgeries.
Exclusion Criteria
I do not have implanted devices unsuitable for MRI, neurological conditions, current cancer, clotting disorders, inflammatory conditions, am not pregnant, and can undergo procedures involving needles and confined spaces.
SCI participants: Use of botox in the past 3 months that reduces skeletal muscle function; other neurologic conditions (i.e. brain injury, stroke, HIV); current cancer diagnosis; active deep vein thrombosis and anti-coagulation therapy; skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training; pregnancy; ventilator-dependence; cognitive conditions that preclude providing informed consent; Implanted medical devices that are contraindicated for electrical stimulation or MRI (If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Biomarker Assessment
Collection and analysis of cerebrospinal fluid and blood to determine inflammatory status and readiness for training
3 months
1-2 visits (in-person)
Treatment
12-week downhill training program combined with electrical stimulation, conducted 3 times a week
12 weeks
36 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including biomechanical analysis and clinical outcome measures
4 weeks
2 visits (in-person)
Participant Groups
The study tests a new rehabilitation treatment combining downhill treadmill training with electrical muscle stimulation against standard rehab alone. It aims to determine the optimal timing to start this program by analyzing biomarkers in blood and spinal fluid and assessing recovery of movement through MRI scans.
4Treatment groups
Experimental Treatment
Active Control
Group I: SCI No GoExperimental Treatment1 Intervention
Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.
Group II: SCI GoExperimental Treatment1 Intervention
Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.
Group III: SCI SOCActive Control1 Intervention
Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.
Group IV: Healthy ControlActive Control1 Intervention
Healthy controls will provide biomarker and/or myelin (MRI) data
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
United States Department of DefenseCollaborator
University of Notre DameCollaborator
University of British ColumbiaCollaborator
References
[Robotic systems for gait re-education in cases of spinal cord injury: a systematic review]. [2018]The evidence underlying robotic body weight supported treadmill training in patients with spinal cord injury remains poorly characterized.
Locomotor training and muscle function after incomplete spinal cord injury: case series. [2022]To determine whether 9 weeks of locomotor training (LT) results in changes in muscle strength and alterations in muscle size and activation after chronic incomplete spinal cord injury (SCI).
Effects of a combined progressive resistance training and functional electrical stimulation-evoked cycling exercise on lower limb muscle strength of individuals with incomplete spinal cord injury: A randomized controlled study. [2023]This study was conducted to investigate the effects of combined progressive resistance training (PRT) and functional electrical stimulation-evoked leg cycling exercise (FES-LCE) on isometric peak torque and muscle volume in individuals with incomplete spinal cord injury.
The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. [2022]A training intervention study using standing dynamic load-shifting Functional Electrical Stimulation (FES) in a group of individuals with complete spinal cord injury (SCI) T2 to T10.
Long-term use of computerized bicycle ergometry for spinal cord injured subjects. [2006]Twenty-eight spinal cord injured subjects who participated in an electrical stimulation bicycle ergometry home program were surveyed to determine perceived benefits, home exercise adherence, and predictors of continued home exercise with electrical stimulation. Subjects were classified as users or nonusers depending upon if they used the electrical stimulation ergometry on a regular basis in the home during the past four months. Nineteen subjects qualified as users and nine were nonusers. Ninety-five percent of the users cycled at least twice per week whereas the majority of the nonusers stopped regular home exercise within one month postclinic discharge. All subjects generally perceived increases in muscle bulk and endurance. Users and nonusers perceived inconsistent results related to spasticity. Minimal effects were noted with neurogenic pain and swelling. Adherence to the home exercise program was significantly related to sex of subject and pre-injury exercise habits. Results are discussed in relation to the costs and benefits of electrical stimulation bicycle ergometry in the home.
[Electric stimulation in muscle training of the lower extremities in persons with spinal cord injuries]. [2006]Spinal cord injured persons have limited possibilities to perform physical training. By use of computerized, feed-back controlled electrical stimulation of the gluteal, the hamstrings and the quadriceps muscles cycle ergometry can be performed by the spinal cord injured individual. The cardiovascular demands of this training is higher than with voluntary upper body training using the intact innervated muscles. The inactivity related conditions caused by the spinal cord injury are reversed in part by regular electrically stimulated training. An increase is seen in maximal oxygen consumption, in the insulin stimulated glucose uptake and in the muscular mass and bone mineral content of the lower extremities. Electrically induced cycle ergometry is thoroughly investigated, relatively safe, but time consuming. As this training in addition results in the same well being as seen by training in able bodied individuals it can be recommended for motivated patients.
Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. [2022]The aim was to assess safety and feasibility of Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) leg cycling and arm ski ergometer in people with Spinal Cord Injuries (SCI).
Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. [2019]To assess changes in peak functional aerobic power after a 36-session, progressive functional electric stimulation (FES) rowing hybrid training program for persons with spinal cord injury (SCI) and to examine the safety and acceptability of the ROWSTIM II device as well as the integrity of technical modifications to it.
Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. [2004]This study investigated the safety and effects of computerized functional electrical stimulation (FES) on spinal cord injured individuals. Nineteen subjects two to ten years postinjury, with clinically complete motor and sensory lesions between C4 and T10, participated. All subjects met the specific selection criteria. None had received lower extremity electrical stimulation before. In phase I, subjects received surface electrical stimulation to the quadriceps muscle bilaterally for resistive knee extension 3 times a week for four weeks. The resistance and number of completed lifts was recorded daily. In phase II, 36 sessions provided sequential surface electrical stimulation to the quadriceps, hamstrings, and gluteus muscles bilaterally in order for subjects to pedal a lower extremity ergometer with resistance varied depending on completed run time. For each session, heart rate, blood pressure, temperature, and work performance were recorded. Tests done before and after the training program included fasting blood chemistries, 24-hour urinalysis, arm-crank ergometer stress testing, and midthigh girth measurement. Results indicate that this form of FES is safe, that quadriceps strength and endurance is increased, that endurance for ergometer pedaling is increased, and that there may be a training effect as more work is done at a similar heart rate and systolic blood pressure and as muscle bulk is increased. The FES effect on cardiovascular conditioning and general health requires further research to precisely determine its benefits.
Robot-assisted training with functional electrical stimulation enhances lower extremity function after spinal cord injury. [2022]Functional electrical stimulation (FES) synchronized with robot-assisted lower extremity training is used in spinal cord injury (SCI) rehabilitation to promote residual function.
Physiologic effects of functional electrical stimulation-induced exercises in spinal cord-injured individuals. [2007]Spinal cord injury (SCI) results in multiple degenerative changes that may in part be related to physical inactivity. There are indications that some of these changes may be reversed by exercise and fitness training. Computerized functional electrical stimulation (FES) allows active exercise of limbs paralyzed by upper motor neuron lesions. Thirty SCI subjects safely participated in an FES-induced exercise program for lower extremity strengthening and endurance training. Increased strength, endurance, and bulk of stimulated muscles were noted. The subjects were able to perform a greater amount of work on a lower extremity ergometer, both per unit of time and per length of time, indicating a training effect. A multistage stress test showed evidence that the subjects had increased their aerobic metabolism during the training program. Twitch time tests showed slowing of muscle contraction, and computed tomography showed increased muscle density.
Muscle adaptations in acute SCI following overground exoskeleton + FES training: A pilot study. [2022]To evaluate the combined effects of robotic exoskeleton and functional electrical stimulation (FES) training on muscle composition during over-ground gait training in persons with acute spinal cord injury (SCI).