Functional Task Practice + Electrical Stimulation for Spinal Cord Injury

Overseen By Patricia Bartelt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Must not be taking: Botox

Disqualifiers: Unstable cardiac, respiratory, pregnancy, others

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

Compensation: Varies

Number of Visits: 42

Duration: 8 weeks

99 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing three different types of physical therapy exercises to help people with spinal cord injuries regain movement in their arms and stabilize their trunk. The goal is to retrain the body to move correctly, improving overall function and stability. Participants will undergo multiple sessions and be evaluated at different stages to track their progress.

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 this treatment for spinal cord injury?

Research shows that using functional electrical stimulation (FES) can help improve voluntary grasping and lower extremity function in people with spinal cord injuries. Additionally, combining wide-pulse high-frequency FES with task-specific practice has been shown to enhance upper body strength and function. ^{1 2 3 4 5}

Is Functional Task Practice with Electrical Stimulation safe for humans?

Research on functional electrical stimulation (FES) for spinal cord injury shows it is generally safe, with studies reporting improvements in balance, strength, and cardiovascular fitness without significant safety concerns. ^{4 6 7 8 9}

How does the treatment Functional Task Practice + Electrical Stimulation for Spinal Cord Injury differ from other treatments?

This treatment combines functional task practice with electrical stimulation, which is unique because it uses electrical currents to stimulate nerves and muscles, potentially enhancing motor recovery by promoting neural plasticity (the brain's ability to reorganize itself). Unlike standard rehabilitation, this approach may offer more significant improvements in voluntary motor function by targeting both spinal and cortical networks. ^{1 5 10 11 12}

Eligibility Criteria

This trial is for individuals with a traumatic spinal cord injury (SCI) who are currently in rehabilitation. They must have some movement response to electrical stimulation in their upper body muscles and no severe physical or cognitive issues that would make the treatment unsafe. It's not for those with unstable heart/lung conditions, skin injuries affecting the arms, pregnancy, recent Botox injections, or certain implanted devices.

Inclusion Criteria

SCI categorized as AIS B-D

My spinal cord injury occurred less than 5 months ago.

My spinal cord injury is between levels C1 and C8.

Exclusion Criteria

Implanted devices including pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump

Pregnant

I have received Botox injections in the past 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluation to assess initial capabilities and gather demographic and injury information

1 week

1 visit (in-person)

Treatment

Participants receive 40 sessions of intervention focusing on functional task practice with or without functional electrical stimulation

8 weeks

40 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• FTP Alone
• FTP+Con-FES
• FTP+WPHF-FES

Trial Overview The study compares three treatments aiming to improve arm function and trunk stability after SCI: Functional Task Practice (FTP) alone; FTP combined with conventional Functional Electrical Stimulation (Con-FES); and FTP paired with Weight-Prompted Hand Function FES (WPHF-FES). Participants will undergo 40 sessions of their assigned intervention.

Participant Groups

Group I: FTP+Con-FES Active Control 1 Intervention

Functional Task Practice + Conventional Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with conventional parameter (200µs; 40Hz) functional electrical stimulation (FES). followed by 10 minutes of functional training/carryover in a relevant environment.

Group II: FTP+WPHF-FES Active Control 1 Intervention

Functional Task Practice + Wide Pulse, High Frequency Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with wide pulse, high frequency (1000µs; 100 Hz) functional electrical stimulation (FES) followed by 10 minutes of functional training/carryover in a relevant environment.

Group III: FTP Alone Active Control 1 Intervention

Functional Task Practice Alone - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks followed by 10 minutes of functional training/carryover in a relevant environment without functional electrical stimulation (FES).

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

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]

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]

Transcutaneous electrical stimulation of the spinal cord (TESS) significantly enhances motor-evoked potentials in arm muscles for up to 75 minutes after stimulation, indicating its potential to promote functional recovery in individuals with spinal cord injury (SCI).

The study found that TESS has a dual effect: it excites spinal networks while inhibiting cortical activity, which may contribute to improved hand and arm function, especially when using a specific 5 kHz carrier frequency during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. Benavides, FD., Jo, HJ., Lundell, H., et al.[2021]

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]

A 16-week program of FES-assisted walking significantly improved mobility in individuals with chronic incomplete spinal cord injury compared to a non-FES exercise program, as shown by the increase in the SCIM mobility sub-score.

Both groups showed improvements in walking speed, endurance, and balance, indicating that task-oriented training is beneficial for enhancing walking ability, even in chronic stages of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. Kapadia, N., Masani, K., Catharine Craven, B., et al.[2021]

A novel treatment called high-PAS, which combines high-intensity transcranial magnetic stimulation and high-frequency electrical peripheral nerve stimulation, showed positive therapeutic effects in 20 patients with incomplete spinal cord injuries, improving motor scores and functional independence.

The study indicates that high-PAS can benefit a diverse group of patients, including those with varying injury severity and types, suggesting its potential as a non-invasive and cost-effective approach for spinal cord injury rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Shulga, A., Lioumis, P., Kirveskari, E., et al.[2021]

In a study involving 11 participants with chronic tetraplegia and 10 neurologically healthy individuals, 10-Hz repetitive transcranial magnetic stimulation (rTMS) combined with repetitive task practice (RTP) significantly improved hand function, particularly in the Jebsen-Taylor Hand Function Test, compared to sham-rTMS.

The results suggest that rTMS may enhance the effectiveness of RTP for improving hand function in individuals with tetraplegia, indicating that higher stimulation doses could lead to even greater improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in hand function in adults with chronic tetraplegia following a multiday 10-Hz repetitive transcranial magnetic stimulation intervention combined with repetitive task practice. Gomes-Osman, J., Field-Fote, EC.[2018]

References

1. 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]

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. England pubmed.ncbi.nlm.nih.gov

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

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

Improving Upper Extremity Strength, Function, and Trunk Stability Using Wide-Pulse Functional Electrical Stimulation in Combination With Functional Task-Specific Practice. [2023]

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

Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. [2021]

6. 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]

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

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Functional Electrical Stimulation Plus Visual Feedback Balance Training for Standing Balance Performance Among Individuals With Incomplete Spinal Cord Injury: A Case Series. [2020]

9. France pubmed.ncbi.nlm.nih.gov

A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. [2021]

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

Improvements in hand function in adults with chronic tetraplegia following a multiday 10-Hz repetitive transcranial magnetic stimulation intervention combined with repetitive task practice. [2018]

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

Targeted, activity-dependent spinal stimulation produces long-lasting motor recovery in chronic cervical spinal cord injury. [2018]

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

Effect of functional electrical stimulation (FES) combined with robotically assisted treadmill training on the EMG profile. [2020]