- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309448
Augmenting Reactive Stepping With FES After SCI
March 30, 2021 updated by: University Health Network, Toronto
Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4G 3V9
- Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Perturbation-based balance training with FES
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean-and-release test
Time Frame: Up to 7 weeks
|
Test of reactive stepping and balance in the forward direction
|
Up to 7 weeks
|
Biomechanical measures of postural control
Time Frame: Up to 7 weeks
|
Measurement of centre of pressure during quiet standing
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Up to 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Balance Evaluation Systems Test
Time Frame: Up to 7 weeks
|
Assesses four balance control systems
|
Up to 7 weeks
|
Activities-specific Balance Confidence Scale
Time Frame: Up to 7 weeks
|
Assesses balance efficacy
|
Up to 7 weeks
|
Gait parameters
Time Frame: Up to 7 weeks
|
Step length (cm), gait speed (m/s), double support time (%)
|
Up to 7 weeks
|
Falls Efficacy Scale International
Time Frame: Up to 7 weeks
|
Assesses the degree of concern about fear of falling
|
Up to 7 weeks
|
Semi-structured interview
Time Frame: 3 months post
|
Queries the participants' perceived challenges and benefits of the PBT+FES program
|
3 months post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ACTUAL)
March 17, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
March 12, 2020
First Posted (ACTUAL)
March 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-5462
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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