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Completed

NCT Number: NCT04881565

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KITE-Toronto Rehabilitation Institute, UHN

Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Lean-and-Release Test

    Time frame: Change from baseline to 6-month follow-up

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

Secondary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: Change from baseline to 6-month follow-up

    Minimum score: 0, maximum score: 56, higher scores reflect better balance control.

  2. Proprioception of the ankle joints

    Time frame: Change from baseline to 6-month follow-up

    To test proprioception, participants will assume a supine position with their eyes closed while the blinded assessor moves the ankle joint six times slowly through 10° of dorsiflexion (i.e. up) or plantarflexion (i.e. down). Participants will be asked to state the perceived direction of movement (i.e. up or down). This process will be repeated six times for each ankle, with a score of 1 assigned for each correct response. Each ankle will receive a maximum score of 6 for a total possible score of 12 (i.e. 2 joints x 6 trials/joint).

  3. Tracking falls

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

    Falls will be monitored for six months following the intervention

  4. Isometric strength

    Time frame: Change from baseline to 6-month follow-up

    The isometric strength of eight lower extremity muscle groups (hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors, ankle dorsiflexors) will be tested bilaterally using hand-held dynamometry.

  5. Falls Efficacy Scale - International (FES-I)

    Time frame: Change from baseline to 6-month follow-up

    Minimum score: 16, maximum score: 64. A greater score means lower falls self-efficacy.

  6. Activities-specific Balance Confidence (ABC) Scale

    Time frame: Change from baseline to 6-month follow-up

    Minimum score: 0%, maximum score 100%. A greater score means greater balance confidence.

  7. mini-Balance Evaluation Systems Test (mini-BESTest) Reactive Postural Control Subscale

    Time frame: Change from baseline to 6-month follow-up

    Minimum score: 0, maximum score: 6. A greater score means greater reactive postural control.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Losing Balance to Prevent Falls After Spinal Cord Injury

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 11, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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