NCT04881565

Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)

Losing Balance to Prevent Falls After Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Reactive balance training	During each one-hour session, participants will experience 40-50 perturbations (i.e. approximately one perturbation per training minute) during standing and/or walking activities. The perturbations will be applied in any direction (e.g. forwards, sideways, backwards, etc.) To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness at waist level. The perturbation will be sufficient in magnitude to elicit a stepping response from the participant. Throughout the session, participants will complete challenging balance tasks, customized to their ability level. Balance tasks will be organized into five categories: stable, quasi-mobile, mobile, unpredictable and participant-selected.

Timeline

• Start date: 2021-09-27
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-05-11
• Last updated: 2026-03-30

Locations

1 site across 1 country: Canada