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Augmenting Reactive Stepping With FES After SCI

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Perturbation-based balance training with functional electrical stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perturbation-based balance training with FES

Arm Description

Outcomes

Primary Outcome Measures

Lean-and-release test
Test of reactive stepping and balance in the forward direction
Biomechanical measures of postural control
Measurement of centre of pressure during quiet standing

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2020
Last Updated
March 30, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04309448
Brief Title
Augmenting Reactive Stepping With FES After SCI
Official Title
Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perturbation-based balance training with FES
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Perturbation-based balance training with functional electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lean-and-release test
Description
Test of reactive stepping and balance in the forward direction
Time Frame
Up to 7 weeks
Title
Biomechanical measures of postural control
Description
Measurement of centre of pressure during quiet standing
Time Frame
Up to 7 weeks
Secondary Outcome Measure Information:
Title
Mini-Balance Evaluation Systems Test
Description
Assesses four balance control systems
Time Frame
Up to 7 weeks
Title
Activities-specific Balance Confidence Scale
Description
Assesses balance efficacy
Time Frame
Up to 7 weeks
Title
Gait parameters
Description
Step length (cm), gait speed (m/s), double support time (%)
Time Frame
Up to 7 weeks
Title
Falls Efficacy Scale International
Description
Assesses the degree of concern about fear of falling
Time Frame
Up to 7 weeks
Title
Semi-structured interview
Description
Queries the participants' perceived challenges and benefits of the PBT+FES program
Time Frame
3 months post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a motor incomplete SCI (i.e., AIS grade C or D) that is non-progressive; be at least one year post-injury (i.e., chronic injury); ≥ 18 years old; be able to stand independently for 60 sec; unable to take a step bilaterally without physical assistance or upper extremity support; able to understand spoken English; free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke); be able to provide informed, written consent. Exclusion Criteria: 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; severe spasticity is present in the legs; the person has contractures in the lower limbs that prevent achieving a neutral hip and ankle position, or extended knee; there is a history of prior lower limbs fragility fracture; the leg muscles are unresponsive to electrical stimulation (i.e., peripheral nerve damage in the legs). Pressure sores on pelvis or trunk, where safety harness will be donned.
Facility Information:
Facility Name
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

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Augmenting Reactive Stepping With FES After SCI

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