Status:
COMPLETED
Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
Lead Sponsor:
University Health Network, Toronto
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04881565
Start Date
September 27 2021
End Date
December 30 2024
Last Update
April 8 2025
Active Locations (1)
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1
KITE-Toronto Rehabilitation Institute, UHN
Toronto, Canada