FES Therapy + Task-Specific Training for Spinal Cord Injury

Overseen By Lamisa Etu, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Neurological diseases, Mental illness, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FEST+TST for spinal cord injury?

Research shows that using functional electrical stimulation (FES) with other therapies can improve movement and function in people with spinal cord injuries. Studies have found that FES combined with specific training helps enhance lower limb function and voluntary grasping, suggesting it may be effective for rehabilitation. ^{1 2 3 4 5}

Is FES Therapy + Task-Specific Training safe for humans?

Functional Electrical Stimulation (FES) has been studied in people with spinal cord injuries and other conditions, showing improvements in function without significant safety concerns reported. However, more research is needed to fully understand its safety profile when combined with Task-Specific Training. ^{1 3 4 5 6}

How is the treatment FES Therapy + Task-Specific Training for Spinal Cord Injury different from other treatments?

FES Therapy + Task-Specific Training (FEST+TST) is unique because it combines functional electrical stimulation (FES), which uses electrical impulses to activate muscles, with task-specific training, focusing on improving specific movements. This approach is different from standard therapies as it aims to enhance both muscle activation and functional movement in individuals with spinal cord injury. ^{1 2 4 7 8}

Research Team

Julio Furlan, MD, PhD

Principal Investigator

KITE, Toronto Rehab-University Health Network

Eligibility Criteria

This trial is for individuals in the early stages (less than 3 months) after a traumatic spinal cord injury at the neck level that still allows for some movement. It's not suitable for those with other medical conditions affecting treatment, neurological diseases, severe mental illness, learning disabilities, recent substance abuse, MRI contraindications, or sensory deficits impacting tests.

Inclusion Criteria

My spinal cord injury is recent, partial, and in the neck area.

Exclusion Criteria

I do not have any health conditions that prevent me from receiving FEST.

I have a neurological condition like peripheral neuropathy.

Contraindication to MRI scanning

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Treatment

Participants receive FEST+TST at 3 to 6 months from SCI onset

3 months

Delayed Treatment

Participants receive FEST+TST at 6 to 9 months from SCI onset

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• FEST+TST

Trial Overview The study examines if the timing of functional electrical stimulation therapy combined with task-specific training (FEST+TST) affects recovery of function and nerve health following a cervical spinal cord injury.

Participant Groups

Group I: Early FEST + TST Experimental Treatment 1 Intervention

Participants will receive FEST+TST at 3 to 6 months from SCI onset.

Group II: Delayed FEST + TST Experimental Treatment 1 Intervention

Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Insights on the Potential Mechanisms of Action of Functional Electrical Stimulation Therapy in Combination With Task-Specific Training: A Scoping Review. [2022]

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

Functional electrical stimulation therapy of voluntary grasping versus only conventional rehabilitation for patients with subacute incomplete tetraplegia: a randomized clinical trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for the upper limb in tetraplegic spinal cord injury: a systematic review. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study. [2020]

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

Restoring voluntary grasping function in individuals with incomplete chronic spinal cord injury: pilot study. [2022]

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

Functional electric stimulation to augment partial weight-bearing supported treadmill training for patients with acute incomplete spinal cord injury: A pilot study. [2019]