Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
Toronto, Ontario, M4G 3V9, Canada
NCT Number: NCT04309448
Up to 25 individuals living with chronic incomplete spinal cord injury (iSCI) who can stand but have limited ability to elicit a step without physical assistance or upper limb (U/L) support will be recruited for this study. The first objective of the study will aim to investigate the orthotic effect (i.e., immediate effect) of FES on the reactive stepping response. The second objective is to investigate the therapeutic effect of a novel balance intervention, perturbation-based balance training (PBT) combined with FES (i.e., PBT+FES) on reactive stepping ability, measures of postural sway during quiet standing (i.e., biomechanical measures), and scores on clinical measures of balance and walking.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M4G 3V9, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PBT program will consist of repetitive practice of reactive stepping for one hour. The participants will be equipped with the Odstock 2-Channel stimulator on one or both sides depending on their deficits. One channel of stimulation may be applied to the common fibular nerve to elicit a flexor withdraw reflex and elicit a step. The second channel of stimulation may be applied to the quadriceps muscles to assist with the supporting phase of the reactive step, as required. Participants will experience about 60 perturbations per session during balance exercises. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. Throughout the hour-long session, participants will complete challenging balance tasks, customized to their ability level, during standing and walking. The training will be supervised by a licensed physiotherapist and administered by a licensed physiotherapist or registered kinesiologist.
Time frame: Up to 7 weeks
Test of reactive stepping and balance in the forward direction
Time frame: Up to 7 weeks
Measurement of centre of pressure during quiet standing
Time frame: Up to 7 weeks
Assesses four balance control systems
Time frame: Up to 7 weeks
Assesses balance efficacy
Time frame: Up to 7 weeks
Step length (cm), gait speed (m/s), double support time (%)
Time frame: Up to 7 weeks
Assesses the degree of concern about fear of falling
Time frame: 3 months post
Queries the participants' perceived challenges and benefits of the PBT+FES program
University Health Network, Toronto
Other
Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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