Augmenting Reactive Stepping With FES After SCI

NCT04309448 | Completed

• 1 other identifier: 19-5462
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Lean-and-release test

  Test of reactive stepping and balance in the forward direction

  Up to 7 weeks

• Biomechanical measures of postural control

  Measurement of centre of pressure during quiet standing

  Up to 7 weeks

Secondary Outcomes (5)

• Mini-Balance Evaluation Systems Test

  Up to 7 weeks

• Activities-specific Balance Confidence Scale

  Up to 7 weeks

• Gait parameters

  Up to 7 weeks

• Falls Efficacy Scale International

  Up to 7 weeks

• Semi-structured interview

  3 months post

Study Arms (1)

Perturbation-based balance training with FES

EXPERIMENTAL

Behavioral: Perturbation-based balance training with functional electrical stimulation

Interventions

Perturbation-based balance training with functional electrical stimulation BEHAVIORAL

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.

Perturbation-based balance training with FES

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: September 1, 2019
• Primary Completion: March 17, 2020
• Study Completion: June 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CA (1)