Clinical trial NCT04881565: Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
Official title: Losing Balance to Prevent Falls After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: balance training
falls
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participant sustained a traumatic or non-progressive, non-traumatic motor iSCI (i.e. AIS C or D).
2. Injury occurred more than a year prior to study enrollment (when natural recovery has plateaued).8,9
3. Participant is ≥18 years old.
4. Participant can attend three training sessions/week for six weeks (i.e. has reliable transportation).
5. 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.
6. 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:

1. Participant presents with contraindications to FES (i.e. implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy).12
2. Participant presents with other conditions besides iSCI that affect balance (e.g. vestibular disorder, brain injury).
3. 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.
4. Participant has a history of a lower limb fragility fracture.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change from baseline to 6-month follow-up
measure: mini-Balance Evaluation Systems Test
timeFrame: Change from baseline to 6-month follow-up
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from baseline to 6-month follow-up
measure: Falls Efficacy Scale - International
timeFrame: Change from baseline to 6-month follow-up
measure: Isometric strength
timeFrame: Change from baseline to 6-month follow-up
measure: Proprioception of the ankle joints
timeFrame: Change from baseline to 6-month follow-up
measure: Lean-and-Release Test
timeFrame: Change from baseline to 6-month follow-up
measure: Tracking falls
timeFrame: Change from beginning to end of 6-month follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE-Toronto Rehabilitation Institute, UHN
Study officials:
affiliation: University Health Network, Toronto
name: Kristin E Musselman, PhD
role: PRINCIPAL_INVESTIGATOR
References: