Evaluation of FES+VFBT With Individuals With Lived Experience

NCT05744271 | Completed

• 1 other identifier: 22-5868
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Falls are a concern for people living with spinal cord injury (SCI) or stroke. Falls may result in injury and a fear of falling, which often cause people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI or stroke has not been studied in detail, and as a result, there is a lack of treatments to address their high fall risk. Functional electrical stimulation (FES) is the application of a mild electrical stimulus to a muscle that helps it move better. In this study, the MyndSearch device will be used to deliver FES. The visual feedback balance training (VFBT) is similar to playing a video game on a balance board while following visual cues on a screen. The purpose of this study is to evaluate an intervention that combines FES and VFBT to improve balance and lead to the recovery of safe mobility in individuals living with neurological disease or injury (e.g., spinal cord injury, stroke).

Conditions

Stroke; Spinal Cord Injuries

Keywords

Balance; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (7)

• Change in Berg Balance Scale score

  Scores range from 0-56, higher score equals greater balance

  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

• Change in Activities-specific Balance Confidence Scale score

  Scores range from 0-100%, higher score equals greater confidence in balance

  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

• Change in strength of the trunk and lower extremity

  The force, measured in lbs or kg, of eight lower extremity muscle groups (i.e. hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors and ankle dorsiflexors) will be measured using a hand-held dynamometer. Scores range from 0-40, higher score equals greater strength.

  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

• Change in static standing balance

  Will be assessed by measuring postural sway during quiet standing on the force sensing mat for 60 seconds under two conditions presented in a random order: eyes open and eyes closed. The amount of body sway, such as COP amplitude and speed, will be quantified to examine the change of static balance as well as reliance on the visual information.

  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

• Change in dynamic standing balance

  Will be assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on the force sensing mat (i.e. limits of stability test). The maximum centre of pressure (COP) amplitude in the anterior, posterior and mediolateral directions will be recorded. The change of COP amplitude will be assessed. Electromyography will be recorded in the major leg muscles. The change in co-contraction and muscle synergy will be investigated to quantify the change in muscle activation pattern by the intervention.

  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

• Questionnaire on the participants' perspectives of the FES+VFBT intervention

  Immediately after the intervention

• Semi-structured interview on the participants' perspectives of the FES+VFBT intervention

  Immediately after the intervention

Secondary Outcomes (3)

• Change in cutaneous pressure sensation

  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

• Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints

  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

• Change of corticospinal excitability

  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

Study Arms (1)

FES+VFBT

EXPERIMENTAL

Functional electrical stimulation combined with visual feedback balance training

Device: FES+VFBT

Interventions

FES+VFBT DEVICE

Standing balance training with the FES+VFBT system will occur 3x/week for six weeks (i.e. 18 sessions). Electrodes will be placed on the participants' plantarflexors and dorsiflexors bilaterally and FES will be administered using the device, MyndSearch, during the balance training exercises. Each session will last one hour, including 5 min to identify motor thresholds and maximum tolerable stimulation levels, 2 min to don/doff the safety harness, 5 min to calibrate the FES+VFBT exercises, up to 48 min to complete the FES+VFBT exercises. Rest breaks will be taken as needed.

FES+VFBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• chronic stage of recovery (i.e. \>1 year post-SCI/D or stroke), when natural recovery has plateaued
• ≥18 years old
• able to stand independently for 60 seconds
• 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);
• free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss)
• able to understand spoken English

You may not qualify if:

• a prior lower extremity fragility fracture
• an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period
• peripheral nerve damage in the legs
• 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
• contraindications for TMS (i.e. history of epilepsy and/or seizures)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

KITE-Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kristin E Musselman, PhD

  KITE-Toronto Rehabilitation Institute, UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Performance on clinical measures will be evaluated by a physical therapist who is blind to the study purpose, design, and intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 24, 2023
• Study Start: April 1, 2023
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CA (1)