Spinal Cord InjuriesNCT04309448
Augmenting Reactive Stepping With FES After SCI
A study testing Perturbation-based balance training with functional electrical stimulation in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Perturbation-based balance training with functional electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
Toronto, Ontario, M4G 3V9
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Perturbation-based balance training with functional electrical stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation-based balance training with functional electrical stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-based balance training with FES | Experimental | Not described Receives: Behavioral: Perturbation-based balance training with functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean-and-release test
Test of reactive stepping and balance in the forward direction
Measured: Up to 7 weeks
Biomechanical measures of postural control
Measurement of centre of pressure during quiet standing
Measured: Up to 7 weeks
Secondary outcomes (5)
Mini-Balance Evaluation Systems Test
Assesses four balance control systems
Measured: Up to 7 weeks
Activities-specific Balance Confidence Scale
Assesses balance efficacy
Measured: Up to 7 weeks
Gait parameters
Step length (cm), gait speed (m/s), double support time (%)
Measured: Up to 7 weeks
Falls Efficacy Scale International
Assesses the degree of concern about fear of falling
Measured: Up to 7 weeks
Semi-structured interview
Queries the participants' perceived challenges and benefits of the PBT+FES program
Measured: 3 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Sep 2019
- Primary completion17 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309448
- Sponsor's protocol ID
- 19-5462
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04309448
- Acronym / sponsor ID
- 19-5462
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perturbation-based balance training with FES | Experimental | Behavioral: Perturbation-based balance training with functional electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- Contraindications for EMS. Electrical stimulation will not be used if:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perturbation-based balance training with functional electrical stimulationThe 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. | Behavioural | Perturbation-based balance training with FES |
Primary outcome
Lean-and-release test
Time frame: Up to 7 weeks
Test of reactive stepping and balance in the forward direction
Biomechanical measures of postural control
Time frame: Up to 7 weeks
Measurement of centre of pressure during quiet standing
5 secondary outcomes
Mini-Balance Evaluation Systems Test
Time frame: Up to 7 weeks
Activities-specific Balance Confidence Scale
Time frame: Up to 7 weeks
Gait parameters
Time frame: Up to 7 weeks
Falls Efficacy Scale International
Time frame: Up to 7 weeks
Semi-structured interview
Time frame: 3 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perturbation-based balance training with functional electrical stimulation in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean-and-release test (time frame: Up to 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.