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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals regain movement in their arms and upper bodies after a spinal cord injury. The researchers are testing three approaches: one using only exercises (Functional Task Practice, or FTP Alone), and two combining exercises with different types of electrical stimulation, which uses small electrical pulses to aid muscle movement. Each approach aims to improve daily tasks and stabilize the trunk area. Individuals who have experienced a traumatic spinal cord injury within the last five months and are currently in rehabilitation may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and advance spinal cord injury rehabilitation.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research on functional electrical stimulation (FES) for spinal cord injuries shows it is generally safe. Studies report that FES can help improve balance and strength. Most people tolerate FES well, and current research raises no major safety concerns.

For treatments using wide pulse, high frequency FES, evidence also supports its safety. People with spinal cord injuries have shown improvements in upper body strength and balance. Studies have not reported any significant negative effects from using FES for spinal cord injury recovery.

This study tests Functional Task Practice alone and with two types of FES. Past research indicates that both types of FES are safe, suggesting that participants are likely to tolerate the treatments well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injury because they explore how different forms of electrical stimulation can enhance functional recovery. The FTP+Con-FES and FTP+WPHF-FES treatments combine functional task practice with conventional and wide pulse, high frequency electrical stimulation, respectively. This approach aims to improve muscle activation and task performance more effectively than standard rehabilitation methods, which typically don't incorporate electrical stimulation. The unique aspect of these treatments is their focus on using specific electrical parameters to potentially accelerate and enhance the recovery of motor functions. By systematically comparing these approaches, the trial hopes to uncover the most effective method for improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that practicing everyday tasks, known as Functional Task Practice (FTP), can improve sitting and standing balance for people with spinal cord injuries. In this trial, participants will be divided into groups to test various approaches. One group will receive FTP alone. Another group will receive FTP combined with Conventional Functional Electrical Stimulation (Con-FES), which studies have found greatly enhances the ability to grasp objects and improves leg function. A third group will receive FTP combined with Wide Pulse, High Frequency Functional Electrical Stimulation (WPHF-FES), which has led to significant improvements in arm strength, function, and trunk balance. These methods use electrical stimulation to activate muscles and help restore movement. Overall, combining FTP with either type of electrical stimulation shows promise in boosting recovery and function after a spinal cord injury. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-spinal-cord-injuries-2022-7bf61

Functional Task Practice + Electrical Stimulation for Spinal ... In a study involving 72 spinal cord injury patients, functional electrical stimulation (FES) combined with robot-assisted training significantly improved both ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584753/

Functional Electrical Stimulation in Spinal Cord Injury This article outlines steps to practical application of functional electrical stimulation (FES) within activity-based restorative therapy (ABRT).

3. tandfonline.com tandfonline.com/doi/full/10.1080/10833196.2025.2528408

Functional electrical stimulation for improving upper limb ... In contrast, one study found FES to be as effective as conventional therapy, implying a suitable alternative. Conclusion. Overall, moderate evidence supports ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7364342/

Functional Electrical Stimulation Therapy for Retraining ... The FES therapy protocols can be successfully applied to individuals with paralysis resulting from stroke or spinal cord injury.

5. nature.com nature.com/articles/3102091

Functional electrical stimulation after spinal cord injury This review presents an overview of the progress made, describes the current challenges and suggests ways to improve further FES systems and make these more ...