RecruitingNAINTERVENTIONAL

Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial

This study aims to discover better ways to help people who have had a stroke to improve their balance and reduce their risk of falling. Many stroke survivors find their balance is affected, and falls can unfortunately be common, even a year after the stroke. We want to see if adding a special kind of gentle electrical stimulation, called tSCS, to regular balance training can make a real difference. We'll be comparing people who get this stimulation with those who receive a 'sham' (fake) stimulation, so we can carefully study the effects on their balance, movement, and nerve activity. Our hope is to develop more effective treatments to help stroke survivors stay steady on their feet.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

21 May 2025

Estimated completion

01 Dec 2027

Stroke

What is this study about?

Imagine you've had a stroke, and now you're working hard to get back to everyday life. One of the biggest challenges for many people after a stroke is keeping their balance, and unfortunately, falls can be a worry. Even as you get fitter and move around more in the first year after a stroke, the risk of falling can still be high.

Doctors and researchers are always looking for better ways to help. This study is exploring a new approach that might help to improve your balance and prevent falls. It's looking at whether combining standard balance exercises with a gentle electrical current, called 'transcutaneous spinal cord stimulation' (or tSCS for short), can make rehabilitation more effective. This gentle stimulation is applied to your skin, aiming to help your nerves involved in balance work better.

In this study, some people will receive true tSCS alongside their balance training, while others will receive a 'sham' (or fake) stimulation. This helps the researchers understand if the real stimulation is genuinely making a difference, or if the improvements are due to the exercises alone or other factors. By carefully comparing these groups, the study hopes to find new and better ways to help stroke survivors feel more stable and confident on their feet.

Key takeaways

This study explores a new way to improve balance and prevent falls after a stroke.
It combines balance exercises with gentle electrical stimulation (tSCS).
Participation involves balance training and assessments.
Open to adults who had a stroke over a year ago and live at home.
Aims to find more effective rehabilitation methods for stroke survivors.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over and have had a stroke affecting the middle part of your brain over a year ago. You should also be living independently at home, not in a nursing home or similar facility.

An important part of this study is that you must be able to stand on your own for at least 60 seconds without help, and you need to understand spoken English.

There are also some reasons why you might not be able to join. For example, if you have other health problems that greatly affect your balance (like certain inner ear issues or severe vision problems), or if you've had a broken bone in your leg that happened easily. You also can't join if you have certain medical devices implanted, like a pacemaker, or if you're pregnant, have active cancer, or certain skin conditions where the electrical patches would go. If you've had seizures or have metal in your head, you might also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you have a stroke over one year ago?
Do you live independently at home (not in a care facility)?
Can you stand on your own for at least 60 seconds?
Do you understand spoken English?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive several sessions of balance training. During these sessions, you would also have a gentle stimulation applied to your skin, either the active 'tSCS' or a 'sham' (inactive) version. Before, during, and after this training, researchers would conduct various assessments to measure your balance, how you move, and how your nerves are working. This might include practical balance tests and possibly some gentle electrical tests on your muscles. The total duration of your participation, including all visits and follow-up, would be outlined by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as improvements in your balance and a reduced risk of falls through the rehabilitation and stimulation. However, there's no guarantee that you will personally benefit from the intervention. Potential risks associated with electrical stimulation are generally mild and temporary, such as skin irritation where the patches are applied. You will be closely monitored for any discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is tSCS?

tSCS stands for 'transcutaneous spinal cord stimulation.' It's a gentle electrical current applied to the skin over your back, aiming to help the nerves involved in balance work better.

Will I know if I'm getting the real or fake stimulation?

No, you won't know whether you're receiving the active tSCS or the 'sham' (inactive) stimulation. This helps researchers get accurate results.

How long has it been since my stroke to join?

To join this study, it needs to have been more than one year since you had your stroke.

Can I still take part if I live with family?

Yes, as long as you are living in your own home or with family, and not in a long-term care facility, you may be eligible.

What kind of exercises will I do?

The study involves balance training exercises tailored to help improve your stability and reduce your risk of falling.

How to find out more

Kristin E Musselman, PhD

kristin.musselman@uhn.ca 416-597-3422 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.