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

Trial Summary

What is the purpose of this trial?

People living with stroke have a high risk of falling and this risk increases as mobility improves over the first year post-stroke. Despite the high number of falls, there is a lack of interventions to prevent falls after stroke. One possible solution is to alter nerve activity through delivery of a stimulus, such as electrical stimulation. The purpose of this study is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures of combining electrical stimulation with balance training.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+