Augmenting Reactive Stepping With FES After SCI

NCT ID: NCT04309448

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perturbation-based balance training with FES

Group Type: EXPERIMENTAL

Perturbation-based balance training with functional electrical stimulation

Intervention Type: 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.

Interventions

Perturbation-based balance training with functional electrical stimulation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

19-5462

Identifier Type: -

Identifier Source: org_study_id