Status:
COMPLETED
Augmenting Reactive Stepping With FES After SCI
Lead Sponsor:
University Health Network, Toronto
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04309448
Start Date
September 1 2019
End Date
June 30 2020
Last Update
April 1 2021
Active Locations (1)
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1
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
Toronto, Ontario, Canada, M4G 3V9