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

Spinal Cord Injuries Clinical Trial

Official title:

Losing Balance to Prevent Falls After Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881565
• Other study ID #: 21-5210
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Reactive balance training
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.

Locations

Country	Name	City	State
Canada	KITE-Toronto Rehabilitation Institute, UHN	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale		Change from baseline to 6-month follow-up
Primary	mini-Balance Evaluation Systems Test		Change from baseline to 6-month follow-up
Primary	Activities-specific Balance Confidence Scale		Change from baseline to 6-month follow-up
Primary	Falls Efficacy Scale - International		Change from baseline to 6-month follow-up
Primary	Isometric strength	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.	Change from baseline to 6-month follow-up
Primary	Proprioception of the ankle joints	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).	Change from baseline to 6-month follow-up
Primary	Lean-and-Release Test	A lab-based assessment of reactive stepping ability.	Change from baseline to 6-month follow-up
Primary	Tracking falls	Falls will be monitored for six months following the intervention	Change from beginning to end of 6-month follow-up period