Augmenting Reactive Stepping With FES After SCI

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Perturbation-based balance training with functional electrical stimulation

• Registration Number: NCT04309448
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Primary Completion: 2020-03-17
• Study Completion: 2020-06-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. have a motor incomplete SCI (i.e., AIS grade C or D) that is non-progressive;
2. be at least one year post-injury (i.e., chronic injury);
3. ≥ 18 years old;
4. be able to stand independently for 60 sec;
5. unable to take a step bilaterally without physical assistance or upper extremity support;
6. able to understand spoken English;
7. free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke);
8. be able to provide informed, written consent.

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Exclusion Criteria

1. Contraindications for EMS. Electrical stimulation will not be used if:

   • it will be applied to areas where it could cause malfunction of electronic devices, including cardiac pacemakers;
   • a woman is pregnant;
   • the applied region has known or suspected malignancy;
   • the person has active deep vein thrombosis or thrombophlebitis;
   • there are active bleeding tissues, or the person has untreated hemorrhagic disorders;
   • there are infected tissues, tuberculosis, or wounds with underlying osteomyelitis;
   • tissues have been radiated in the past six months;
   • there are damaged skin areas or at-risk skin areas that would result in uneven conduction of current;

2. severe spasticity is present in the legs;

3. the person has contractures in the lower limbs that prevent achieving a neutral hip and ankle position, or extended knee;

4. there is a history of prior lower limbs fragility fracture;

5. the leg muscles are unresponsive to electrical stimulation (i.e., peripheral nerve damage in the legs).

6. Pressure sores on pelvis or trunk, where safety harness will be donned.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perturbation-based balance training with FES	Perturbation-based balance training with functional electrical stimulation	-

Primary Outcome Measures

Name	Time	Method
Lean-and-release test	Up to 7 weeks	Test of reactive stepping and balance in the forward direction
Biomechanical measures of postural control	Up to 7 weeks	Measurement of centre of pressure during quiet standing

Secondary Outcome Measures

Name	Time	Method
Falls Efficacy Scale International	Up to 7 weeks	Assesses the degree of concern about fear of falling
Activities-specific Balance Confidence Scale	Up to 7 weeks	Assesses balance efficacy
Semi-structured interview	3 months post	Queries the participants' perceived challenges and benefits of the PBT+FES program
Mini-Balance Evaluation Systems Test	Up to 7 weeks	Assesses four balance control systems
Gait parameters	Up to 7 weeks	Step length (cm), gait speed (m/s), double support time (%)

Trial Locations

Locations (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN; 🇨🇦 Toronto, Ontario, Canada