Augmenting Reactive Stepping With FES After SCI

Spinal Cord Injuries Clinical Trial

Official title:

Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309448
• Other study ID #: 19-5462
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 30, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Lyndhurst Centre, Toronto Rehabilitation Institute-UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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