Balance Training for Stroke

Overseen By Kristin E Musselman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Vestibular disorder, Vision loss, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if balance training combined with electrical stimulation (a therapy using electrical currents) can reduce falls in individuals who have had a stroke. The researchers seek to find out if this combination improves participants' ability to maintain balance as their mobility improves. Individuals who had a stroke over a year ago, can stand independently for a minute, and live in the community may be suitable candidates. This trial will evaluate the plan and assess the feasibility of recruiting enough participants for a larger future study. As an unphased study, it offers a unique opportunity to contribute to innovative research that could enhance stroke recovery strategies.

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 prior data suggests that this protocol is safe for stroke patients?

Research has shown that electrical stimulation methods, such as functional electrical stimulation (FES) and transcutaneous spinal cord stimulation (tSCS), are generally safe for stroke recovery. Studies have found that FES can safely enhance movement in paralyzed limbs post-stroke. Specifically, one study demonstrated that individuals using FES for walking practice found it both safe and beneficial.

Another study indicated that tSCS, when combined with activity-based training (ABT), is safe for adults with spinal cord injuries. Additionally, studies using non-invasive spinal cord electrical stimulation to improve arm and hand function reported no serious side effects.

These findings suggest that electrical stimulation for balance training during stroke recovery could be safe and well-tolerated. However, individual experiences may vary, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine balance training with innovative electrical stimulation techniques, like Functional Electrical Stimulation (FES) and transcutaneous Spinal Cord Stimulation (tSCS). Unlike traditional stroke rehabilitation methods that typically focus on physical therapy alone, this approach uses electrical currents to potentially enhance nerve activity and muscle function. This could lead to improved balance and mobility for stroke survivors, offering a new way to support recovery beyond standard physical therapy.

What evidence suggests that this trial's treatments could be effective for preventing falls after stroke?

In this trial, participants will receive either a combination of Balance Training with Functional Electrical Stimulation (FES) and Transcutaneous Spinal Cord Stimulation (tSCS) or Balance Training with sham FES and sham tSCS. Research has shown that FES can improve movement after a stroke. One study found that FES increased activity levels more than doing nothing or just exercises. Another type of electrical stimulation, tSCS, also appears to aid movement. Combining FES and tSCS might enhance these improvements, aiding balance and reducing fall risk for stroke survivors. These early results suggest that electrical stimulation could be a valuable tool for stroke recovery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This pilot trial is for individuals who have had a stroke and are at risk of falling. It aims to test if combining electrical stimulation with balance training can help prevent falls post-stroke. The study will also assess the willingness of participants to join and adhere to the study procedures.

Inclusion Criteria

I can stand on my own for at least 60 seconds.

I was diagnosed with a stroke in the middle part of my brain over a year ago.

Able to understand spoken English

Exclusion Criteria

I have a condition like vision loss that affects my balance.

I have had a fracture in my leg due to weak bones.

I am scheduled for a botulinum toxin injection in my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive balance training combined with electrical stimulation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Stimulation

Trial Overview The SPARC trial is examining whether electrical stimulation, when combined with balance training, can improve postural control in people who have suffered from a stroke. This initial phase will evaluate the feasibility of conducting a larger-scale study on this intervention.

How Is the Trial Designed?

Group I: Balance training + FES + tSCS Experimental Treatment 1 Intervention

Group II: Balance training + sham FES + sham tSCS Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

A systematic review on functional electrical stimulation ... The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00718/full

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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999315000441

Functional Electrical Stimulation Improves Activity After ... FES appears to moderately improve activity compared with both no intervention and training alone. These findings suggest that FES should be used in stroke ...

4. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984173/

Therapeutic Effects of Functional Electrical Stimulation on ... This review covers the principles, underlying mechanisms, and therapeutic effects of FES on physical performance and skeletal muscle function in post-stroke ...

6. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42638

Feasibility and safety of automated multi-channel FES ... Conclusion: Automated multi-channel functional electrical stimulation-assisted gait training was feasible, safe, and well received. Preliminary ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

8. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of ...