Balance Training + Electrical Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByKristin E Musselman, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?Falls are a health crisis that cost health care systems billions of dollars/year. This crisis is especially relevant for individuals living with incomplete spinal cord injury (iSCI); 78% fall at least once annually. In able-bodied individuals, falls are prevented by taking reactive steps; however, these reactions are impaired after iSCI. Research in stroke and geriatric rehabilitation showed that reactive balance training (RBT), which targets reactive stepping, prevents falls. We developed a modified version of RBT for the iSCI population. RBT resulted in fewer falls post-training compared to dose-matched, conventional balance training. However, only those who were able to take a step independently and without upper limb support were able to participate in RBT, limiting the applicability of this promising fall prevention method. To address this limitation, we will integrate functional electrical stimulation into RBT (RBT+FES). Our study aims to provide a preliminary evaluation of the efficacy of RBT+FES in participants with chronic, motor iSCI. We will complete a pilot randomized clinical trial (RCT) with 22 participants with iSCI. Participants will be randomly allocated to RBT+FES or to RBT alone (i.e. without FES). They will complete 18 training sessions over 6 weeks (3 sessions/week). Clinical and biomechanical assessments of balance, strength and proprioception will be completed before training, immediately after training, and six months post-training. Falls will be monitored for six months after training through an online survey and regular phone calls. Performance on clinical and biomechanical measures and fall data will be compared between groups. This research will inform the need for, and design of, a larger RCT, and has the potential to transform fall prevention after iSCI.

Eligibility Criteria

This trial is for adults over 18 with chronic motor spinal cord injury at T12 or above, who can stand unassisted for more than 30 seconds and need help to walk. They must be able to attend three sessions a week for six weeks but cannot join if they have lower limb fractures, conditions affecting balance other than iSCI, certain contraindications to electrical stimulation, or severe pressure injuries.

Inclusion Criteria

I need help or a device to walk 10 meters.

I can stand for more than 30 seconds without help.

I had a spinal cord injury above T12 and can move some muscles.

I am 18 years old or older.

Exclusion Criteria

I have conditions like a vestibular disorder or brain injury that affect my balance besides iSCI.

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

I have a severe skin injury on my pelvis, trunk, or foot.

I do not have an implanted electronic device, recent radiation, active DVT, or am not pregnant.

Participant Groups

The study tests reactive balance training (RBT) combined with functional electrical stimulation (RBT+FES) against RBT alone in preventing falls among those with incomplete spinal cord injury. Participants will undergo training thrice weekly for six weeks and their balance, strength, proprioception and fall frequency will be assessed before, after and six months post-training.

2Treatment groups

Experimental Treatment

Active Control

Group I: Reactive balance training plus functional electrical stimulationExperimental Treatment1 Intervention

Group II: Reactive balance trainingActive Control1 Intervention