Muscle Training + Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Lesley Fisher, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Botox, Anti-coagulation therapy

Disqualifiers: Neurologic conditions, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 39

Duration: 12 weeks

49 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{5 6 7 8 9}

How 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. ^{5 6 10 11 12}

Research Team

Michele Basso, EdD

Principal Investigator

Ohio State University

Eligibility 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.)

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)

Treatment Details

Interventions

• Downhill Eccentric Treadmill Training with Electrical Stimulation

Trial Overview 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.

Participant Groups

Group I: SCI No Go Experimental Treatment 1 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 Go Experimental Treatment 1 Intervention

Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.

Group III: SCI SOC Active Control 1 Intervention

Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.

Group IV: Healthy Control Active Control 1 Intervention

Healthy controls will provide biomarker and/or myelin (MRI) data

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Notre Dame

Collaborator

Trials

36

Recruited

60,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Findings from Research

Robotic body weight supported treadmill training shows positive effects on walking parameters in patients with spinal cord injuries, particularly among younger individuals and those with subacute injuries, based on a systematic review of 10 studies involving 286 patients.

The studies utilized robotic devices like Lokomat and Gait Trainer, but the overall evidence is limited and of fair methodological quality, indicating a need for further research to strengthen the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic systems for gait re-education in cases of spinal cord injury: a systematic review]. Gandara-Sambade, T., Fernandez-Pereira, M., Rodriguez-Sotillo, A.[2018]

After 9 weeks of locomotor training, individuals with chronic incomplete spinal cord injury showed significant improvements in muscle strength, particularly in the plantar-flexor muscles, with peak torque increasing by an average of 43.9%.

The training also led to enhanced muscle size and voluntary activation, indicating that locomotor training can effectively improve both muscle function and activation in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training and muscle function after incomplete spinal cord injury: case series. Jayaraman, A., Shah, P., Gregory, C., et al.[2022]

In a study involving 28 participants with incomplete spinal cord injury, combining progressive resistance training (PRT) with functional electrical stimulation-evoked leg cycling exercise (FES-LCE) significantly improved muscle strength, with the left hamstrings showing a 45% increase in peak torque compared to a 4% increase in the FES-LCE only group.

The combination intervention also led to a notable increase in muscle volume in the left leg after 12 weeks, demonstrating that PRT enhances the effectiveness of FES-LCE for improving muscle outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rosley, N., Hasnan, N., Hamzaid, NA., et al.[2023]

In a study involving 12 individuals with complete spinal cord injury, FES-assisted dynamic load-shifting exercises led to significant increases in trabecular bone mineral density (vBMD) in the proximal and distal tibia after 29 weeks of training, indicating potential benefits for bone health in this population.

While improvements were noted in the tibia, there was no increase in vBMD in the distal femur, suggesting that the effectiveness of FES exercises may vary by bone location and type of exercise performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. Armengol, M., Zoulias, ID., Gibbons, RS., et al.[2022]

In a study of 28 spinal cord injured individuals, 95% of those who regularly used electrical stimulation bicycle ergometry at home reported benefits such as increased muscle bulk and endurance, while most nonusers stopped exercising within a month after clinic discharge.

Adherence to the home exercise program was influenced by the subject's sex and their exercise habits before injury, highlighting the importance of personal factors in the effectiveness of electrical stimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of computerized bicycle ergometry for spinal cord injured subjects. Sipski, ML., Alexander, CJ., Harris, M.[2006]

Computerized electrical stimulation allows individuals with spinal cord injuries to perform cycle ergometry, which provides greater cardiovascular benefits than upper body training alone.

Regular electrically stimulated training leads to improvements in maximal oxygen consumption, glucose uptake, muscle mass, and bone mineral content in the lower extremities, making it a recommended option for motivated patients despite being time-consuming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electric stimulation in muscle training of the lower extremities in persons with spinal cord injuries]. Mohr, T.[2006]

Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) was found to be safe and well-accepted by participants with spinal cord injuries, with no serious adverse events reported during the 8-week study involving 8 participants.

Participants experienced a significant 17% increase in peak oxygen uptake (VO2peak) and reported improvements in leisure time physical activity and quality of life, indicating that this training method can enhance physical fitness and overall well-being for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Vestergaard, M., Jensen, K., Juul-Kristensen, B.[2022]

A 12-week progressive functional electric stimulation (FES) rowing training program significantly improved peak functional aerobic power in individuals with spinal cord injury, with peak oxygen consumption increasing by 11.2% and rowing distance by 25%.

The ROWSTIM II device was found to be safe and well-accepted by participants, demonstrating that FES-assisted rowing is an effective training method for enhancing aerobic capacity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Wheeler, GD., Andrews, B., Lederer, R., et al.[2019]

The study involving 19 spinal cord injured individuals demonstrated that computerized functional electrical stimulation (FES) is safe and effective in increasing quadriceps strength and endurance after a training program.

Participants showed improved endurance on a lower extremity ergometer, indicating a potential training effect, as they were able to perform more work at similar heart rates and blood pressure levels, although further research is needed to fully understand the cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. Ragnarsson, KT., Pollack, S., O'Daniel, W., et al.[2004]

In a study involving 72 spinal cord injury patients, functional electrical stimulation (FES) combined with robot-assisted training significantly improved both FES-assisted and voluntary muscle strength in the lower limbs, indicating enhanced motor function.

The results showed a strong correlation between increases in FES-assisted strength and voluntary muscle function, suggesting that this combined approach may effectively support recovery of residual functions after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted training with functional electrical stimulation enhances lower extremity function after spinal cord injury. Bersch, I., Alberty, M., Fridén, J.[2022]

A study involving 30 subjects with spinal cord injury demonstrated that functional electrical stimulation (FES) exercise programs safely improved lower extremity muscle strength, endurance, and bulk.

Participants showed enhanced aerobic metabolism and increased muscle density, indicating that FES can effectively reverse some degenerative changes associated with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic effects of functional electrical stimulation-induced exercises in spinal cord-injured individuals. Ragnarsson, KT.[2007]

Participants with acute spinal cord injury who trained with a robotic exoskeleton and functional electrical stimulation showed significant improvements in muscle volume compared to those receiving standard care alone, indicating enhanced muscle function.

Both groups experienced improvements in static balance, but the intervention group demonstrated greater enhancements, suggesting that early robotic exoskeleton training may be beneficial for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle adaptations in acute SCI following overground exoskeleton + FES training: A pilot study. Hohl, K., Smith, AC., Macaluso, R., et al.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Robotic systems for gait re-education in cases of spinal cord injury: a systematic review]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Locomotor training and muscle function after incomplete spinal cord injury: case series. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term use of computerized bicycle ergometry for spinal cord injured subjects. [2006]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Electric stimulation in muscle training of the lower extremities in persons with spinal cord injuries]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted training with functional electrical stimulation enhances lower extremity function after spinal cord injury. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Physiologic effects of functional electrical stimulation-induced exercises in spinal cord-injured individuals. [2007]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Muscle adaptations in acute SCI following overground exoskeleton + FES training: A pilot study. [2022]