Clinical trial NCT05744271: Evaluation of FES+VFBT with Individuals with Lived Experience
Official title: Evaluation of FES+VFBT with Individuals with Lived Experience
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Stroke
Keywords: Balance
Functional Electrical Stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-subject design will be used, allowing each participant to be his/her own control. Repeated assessments will be taken over three periods: a baseline (i.e. no intervention), intervention, and follow-up.
Primary purpose: TREATMENT

Brief summary: Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults.

A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.


Eligibility criteria: Inclusion Criteria:

1. Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke
2. chronic stage of recovery (i.e. \>1 year post-SCI/D or stroke), when natural recovery has plateaued
3. ≥18 years old
4. able to stand independently for 60 seconds
5. moderate level of trunk control as evidenced by the ability to reach forward \>2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task);
6. free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss)
7. able to understand spoken English

Exclusion Criteria:

1. a prior lower extremity fragility fracture
2. an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period
3. peripheral nerve damage in the legs
4. contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)31
5. contraindications for TMS (i.e. history of epilepsy and/or seizures)

Primary outcomes:
measure: Change in Berg Balance Scale score
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change in Activities-specific Balance Confidence Scale score
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change in strength of the trunk and lower extremity
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change in static standing balance
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change in dynamic standing balance
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Questionnaire on the participants' perspectives of the FES+VFBT intervention
timeFrame: Immediately after the intervention
measure: Semi-structured interview on the participants' perspectives of the FES+VFBT intervention
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change in cutaneous pressure sensation
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
measure: Change of corticospinal excitability
timeFrame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE-Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: KITE-Toronto Rehabilitation Institute, UHN
name: Kristin E Musselman, PhD
role: PRINCIPAL_INVESTIGATOR
References: