Spinal Cord InjuriesiCycleNCT03834324
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury
A study testing FES in people with Spinal Cord Injuries, run by University of Southampton.
Trial summary
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2013to 1 Mar 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. using a wheelchair for at least two hours per day
Who cannot join
- cardiac pacemaker
- pressure sores or unresolved skin problems
- unhealed lower limb fractures
- pregnancy
- active heterotrophic ossification (lower limbs)
- severe osteoporosis
Show all 16Show fewer
- complex regional pain syndrome
- metal implants near electrode sites
- lower limb malignancy
- T6 and below spinal malignancy
- uncontrolled autonomic dysreflexia
- history of knee dislocation/subluxation
- allergy to electrodes
- cognitive difficulties
- severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or
- neurological degenerative diseases.
About this study
Official title: The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.
Read the detailed description
Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.
Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES
- Keywords
- Functional Electrical Stimulation, Cycling, Virtual Reality
- 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.
FESDevice
Functional Electrical Stimulation during cycling with Virtual Reality Feedback
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | FES Receives: Device: FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Neurological Classification
Measured: Change between baseline and 4 weeks
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Neurological Classification
Measured: Change between baseline and 8 weeks
Secondary outcomes (8)
Oxford scale motor power grading
Muscle strength
Measured: Change between baseline and 4 weeks
Oxford scale motor power grading
Muscle strength
Measured: Change between baseline and 8 weeks
Modified Ashworth Score (MAS)
Spasticity / stiffness
Measured: Change between baseline and 4 weeks
Modified Ashworth Score (MAS)
Spasticity / stiffness
Measured: Change between baseline and 8 weeks
Spinal Cord Independence Measure (SCIM)
ADL
Measured: Change between baseline and 4 weeks
Spinal Cord Independence Measure (SCIM)
ADL
Measured: Change between baseline and 8 weeks
Walking Index for Spinal Cord Injury (WISCI II)
Walking ability
Measured: Change between baseline and 4 weeks
Walking Index for Spinal Cord Injury (WISCI II)
Walking ability
Measured: Change between baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start3 May 2013
- Primary completion29 Apr 2016
- Study completion1 Mar 2018
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.
- 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
- Model description
- Technology development and Observational study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Jane Burridge, PhD, University of Southampton
- Investigators
- Trudi Bartlett, BSc, Study chair, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834324
- Sponsor's protocol ID
- 6054
- Acronym
- iCycle
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we have no specific plan for this
Publications
Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.
PubMed 31771600
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03834324
- Acronym / sponsor ID
- iCycle / 6054
- Conditions
- Spinal Cord Injuries
- Keywords
- Functional Electrical Stimulation, Cycling, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 3 May 2013 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 7 Feb 2019 (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.
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.
Detailed description
Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.
Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Technology development and Observational study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: FESFES |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. using a wheelchair for at least two hours per day
Key exclusion criteria (16 listed)
- cardiac pacemaker
- pressure sores or unresolved skin problems
- unhealed lower limb fractures
- pregnancy
- active heterotrophic ossification (lower limbs)
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 |
|---|---|---|
| FESFunctional Electrical Stimulation during cycling with Virtual Reality Feedback | Device | intervention |
Primary outcome
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Time frame: Change between baseline and 4 weeks
Neurological Classification
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Time frame: Change between baseline and 8 weeks
Neurological Classification
8 secondary outcomes
Oxford scale motor power grading
Time frame: Change between baseline and 4 weeks
Oxford scale motor power grading
Time frame: Change between baseline and 8 weeks
Modified Ashworth Score (MAS)
Time frame: Change between baseline and 4 weeks
Modified Ashworth Score (MAS)
Time frame: Change between baseline and 8 weeks
Spinal Cord Independence Measure (SCIM)
Time frame: Change between baseline and 4 weeks
Spinal Cord Independence Measure (SCIM)
Time frame: Change between baseline and 8 weeks
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Change between baseline and 4 weeks
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Change between baseline and 8 weeks
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 8 Oct 2021.
- Results publication: PubMed 31771600Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.
- Individual participant dataSharing planned: No. we have no specific plan for this
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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.
Trudi Bartlett, BSc study chair
University of Southampton
Questions about this trial
What is this clinical trial studying?
A study testing FES in people with Spinal Cord Injuries, run by University of Southampton.
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 1 inclusion and 16 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). (time frame: Change between baseline and 4 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?
On the ClinicalTrials.gov record for NCT03834324, 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 8 Oct 2021.