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

Not Applicable

Active, not recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT04881565
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Study Start: 2021-09-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Participant sustained a traumatic motor iSCI (i.e. AIS C or D) at T12 or above.
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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mini-Balance Evaluation Systems Test	Change from baseline to 6-month follow-up
Isometric strength	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.
Falls Efficacy Scale - International	Change from baseline to 6-month follow-up
Proprioception of the ankle joints	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).
Tracking falls	Change from beginning to end of 6-month follow-up period	Falls will be monitored for six months following the intervention
Berg Balance Scale	Change from baseline to 6-month follow-up
Activities-specific Balance Confidence Scale	Change from baseline to 6-month follow-up
Lean-and-Release Test	Change from baseline to 6-month follow-up	A lab-based assessment of reactive stepping ability (with and without FES).