Spinal Cord InjuriesNCT04262414
Restoring Upright Mobility After Spinal Cord Injury
A study testing Functional Electrical Stimulation in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2017to 5 Jun 2019
- 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
- A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
- ≥18 years old;
- Able to stand independently for 60s;
- Moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and
- Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).
Who cannot join
- Severe spasticity in the legs;
- Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
- A prior lower extremity fragility fracture;
- An injection of botulinum toxin to leg muscles in the past six months;
- Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
- A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; o
- Contraindications for FES52 (i.e. implanted electronic device, active cancer or radiation in past 6 months, epilepsy, skin rash/wound at a potential electrode site).
- Participants will be withdrawn from the study if FES irritates their skin.
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: Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation
Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- Functional Electrical Stimulation
- Keywords
- Balance, Functional Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
The device used was a prototype closed-loop FES system to improve standing balance by activating the ankle plantar flexors and dorsiflexors (i.e. A-FES system). As a closed-loop system, the body's position and velocity are continually monitored, and the level of stimulation adjusted accordingly on a moment-to-moment basis. This differs from currently available FES units, which do not monitor body movement and therefore, provide a constant level of stimulation unless manually adjusted by the user/PT. The control strategy used in the A-FES system mimics the physiological control system in able-bodied people, meaning it has the potential to "re-educate" normal movement patterns.
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome
Measured: Change from Baseline Berg Balance Scale at 8 weeks
Mini-Balance Evaluation Systems Test
Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait
Measured: Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks
Activities-specific Balance Confidence Scale
A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence)
Measured: Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks
Secondary outcomes (3)
Static standing balance
Postural sway during quiet standing
Measured: Through study completion, average of 8 weeks
Dynamic standing balance
Assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on a force plate (i.e. limits of stability test)
Measured: Through study completion, average of 8 weeks
Semi-structured interview
The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy
Measured: up to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start30 Apr 2017
- Primary completion14 Nov 2018
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin E Musselman, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262414
- Sponsor's protocol ID
- 17-5151
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houston DJ, Unger J, Lee JW, Masani K, Musselman KE. Perspectives of individuals with chronic spinal cord injury following novel balance training involving functional electrical stimulation with visual feedback: a qualitative exploratory study. J Neuroeng Rehabil. 2021 Apr 1;18(1):57. doi: 10.1186/s12984-021-00861-z.
PubMed 33794948
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT04262414
- Acronym / sponsor ID
- 17-5151
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Keywords
- Balance, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 10 Feb 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 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
- ≥18 years old;
- Able to stand independently for 60s;
- Moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and
- Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).
Key exclusion criteria (8 listed)
- Severe spasticity in the legs;
- Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
- A prior lower extremity fragility fracture;
- An injection of botulinum toxin to leg muscles in the past six months;
- Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
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 |
|---|---|---|
| Functional Electrical StimulationThe device used was a prototype closed-loop FES system to improve standing balance by activating the ankle plantar flexors and dorsiflexors (i.e. A-FES system). As a closed-loop system, the body's position and velocity are continually monitored, and the level of stimulation adjusted accordingly on a moment-to-moment basis. This differs from currently available FES units, which do not monitor body movement and therefore, provide a constant level of stimulation unless manually adjusted by the user/PT. The control strategy used in the A-FES system mimics the physiological control system in able-bodied people, meaning it has the potential to "re-educate" normal movement patterns. | Device | – |
Primary outcome
Berg Balance Scale
Time frame: Change from Baseline Berg Balance Scale at 8 weeks
Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome
Mini-Balance Evaluation Systems Test
Time frame: Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks
Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait
Activities-specific Balance Confidence Scale
Time frame: Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks
A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence)
3 secondary outcomes
Static standing balance
Time frame: Through study completion, average of 8 weeks
Dynamic standing balance
Time frame: Through study completion, average of 8 weeks
Semi-structured interview
Time frame: up to 8 weeks post-intervention
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 23 May 2023.
- Derived from this study: PubMed 33794948Houston DJ, Unger J, Lee JW, Masani K, Musselman KE. Perspectives of individuals with chronic spinal cord injury following novel balance training involving functional electrical stimulation with visual feedback: a qualitative exploratory study. J Neuroeng Rehabil. 2021 Apr 1;18(1):57. doi: 10.1186/s12984-021-00861-z.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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RecruitingPhase 4
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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.
Kristin E Musselman, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation in people with Spinal Cord Injuries and Spinal Cord Diseases, 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 5 inclusion and 8 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 23 May 2023. 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?
Berg Balance Scale (time frame: Change from Baseline Berg Balance Scale at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262414, which also lists 1 linked publication.
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 23 May 2023.