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

NCT04881565 | Completed

• 1 other identifier: 21-5210
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

balance training; falls

Outcome Measures

Primary Outcomes (1)

• Lean-and-Release Test

  A lab-based assessment of reactive stepping ability (with and without FES).

  Change from baseline to 6-month follow-up

Secondary Outcomes (7)

• Berg Balance Scale (BBS)

  Change from baseline to 6-month follow-up

• Proprioception of the ankle joints

  Change from baseline to 6-month follow-up

• Tracking falls

  Change from beginning to end of 6-month follow-up period

• Isometric strength

  Change from baseline to 6-month follow-up

• Falls Efficacy Scale - International (FES-I)

  Change from baseline to 6-month follow-up

Study Arms (2)

Reactive balance training plus functional electrical stimulation

EXPERIMENTAL

Other: Reactive balance training

Reactive balance training

ACTIVE COMPARATOR

Other: Reactive balance training

Interventions

Reactive balance training OTHER

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.

Reactive balance training; Reactive balance training plus functional electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant sustained a traumatic or non-progressive, non-traumatic motor iSCI (i.e. AIS C or D).
• Injury occurred more than a year prior to study enrollment (when natural recovery has plateaued).8,9
• Participant is ≥18 years old.
• Participant can attend three training sessions/week for six weeks (i.e. has reliable transportation).
• Participant is able to stand for \>30 seconds without upper limb support or assistance (i.e. scores 2/4 on item two of the Berg Balance Scale, Standing Unsupported10). This criterion ensures the participant will be able to participate in upright balance exercises.
• Participant requires physical assistance, a gait aid or a brace to ambulate 10 meters (i.e. self-selected score of 1-19 on the Walking Index for Spinal Cord Injury (WISCI) II).

You may not qualify if:

• Participant presents with contraindications to FES (i.e. implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy).12
• Participant presents with other conditions besides iSCI that affect balance (e.g. vestibular disorder, brain injury).
• Participant has a pressure injury (\>grade 2) on the pelvis or trunk where the safety harness will be applied, or on the foot where the foot switch will be applied.
• Participant has a history of a lower limb fragility fracture.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

KITE-Toronto Rehabilitation Institute, UHN

Toronto, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kristin E Musselman, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical measures of balance, strength and proprioception will be administered by a physical therapist blind to group allocation. The physical therapist will not work at the facility where the research is being conducted, therefore reducing the likelihood of a breach of allocation concealment. If a breach occurs, it will be reported in the final publication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: September 27, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 30, 2026

Record last verified: 2025-03

Locations

CA (1)