Spinal Cord InjuriesiCycleNCT04902482
iCycle II: Recovery of Function Through FES Cycling With VR Biofeedback in People With SCI.
A study testing iCycle Mark 3 in people with Spinal Cord Injuries, run by University College, London at 1 site in United Kingdom.
Trial summary
The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete injuries, with significant potential for neurological improvement. 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?
- iCycle Mark 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2022to 30 Nov 2024
- 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
- >18 years
- Incomplete SCI above T12
- >12 months post injury
- Respond to FES
- No deteriorating condition or other co-morbidity that would make participation impractical or unsafe.
- Marginal walker defined as able to rise from a chair, stand for 10 seconds and walk >10 steps without human help (but may use an aid including parallel bars).
Who cannot join
- Cardiac pacemaker
- Pressure sores/skin problems
- Unhealed lower limb fractures
- Pregnancy
- Active heterotrophic ossification - lower limbs
- Severe osteoporosis
Show all 16Show fewer
- Complex regional pain syndrome
- Implanted metal work at electrode site (< 3/12)
- Lower Limb Malignancy
- T6 and below spinal malignancy
- Uncontrolled autonomic dysreflexia
- History of knee dislocation/subluxation
- Allergy to electrodes
- Cognitive difficulties - must be able to demonstrate an understanding of the iCycle and the virtual reality cycling game
- Severe spasticity - Ashworth scale 4 or 5 in any lower limb muscle groups
- Neurological degenerative diseases
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
Stanmore, Middlesex, HA74LP
Lynsey Duffell, PhD, +44 20 3108 9847, l.duffell@ucl.ac.uk
About this study
Official title: Recovery of Function Through Cycling Therapy With Virtual Reality Biofeedback in Chronically Spinal Cord-injured People
The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective SCI rehabilitation is therefore increasingly important.
The iCycle combines functional electrical stimulation (FES) cycling with VR cycle-racing feedback, where winning correlates with voluntary effort, to promote recovery. The aim is to improve walking in people with incomplete injuries, fundamental to independence and quality of life as well as long-term health. More intensive rehabilitative training is associated with better outcomes: the iCycle has the potential to increase intensity of exercise without additional demands on therapists' time and therefore cost.
Following the encouraging results in an initial study; it is now important to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. Six volunteers with SCI will be recruited to participate in this 20 week, single-site open feasibility trial. The trial consists of an intervention phase lasting up to 12 weeks (3 iCycle sessions per week), and an 8-week follow-up phase. Outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test, Goal Attainment Scale and TMS) will be taken every 4 weeks. The 12-week intervention phase will be separated into three 4-week blocks; at the end of each block participants may decide whether or not they wish to continue training.
Read the detailed description
Recruitment:
Participants will be recruited from London Spinal Cord injuries Centre (LSCIC) at the Royal National Orthopaedic Hospital (RNOH) where the training intervention will be carried out. The study will also be advertised via relevant newsletters, bulletin boards, websites and mailing lists.
For each recruited participant, the study will be conducted for up to 20 weeks in total*. This includes: an intervention phase lasting up to 12 weeks and an 8-week follow-up phase. Outcome measure (OM) assessments will be carried out every 4 weeks (OM1-6) to collect study variables. OM assessments will be conducted by either the researcher or physiotherapist. Each OM assessment session will be broken into two parts, each lasting 2 hours.
- At the end of each 4-week block in the intervention phase, participants will be given the option to continue training for the next 4-week block, or to stop training.
Intervention Phase:
Visit 1: During first outcome measure visit (OM1), participants will attend the Aspire Create labs at the RNOH in Stanmore, where they will be given the opportunity to ask questions about the study, informed consent to participate in the study will be taken and demographic information recorded in the Case Report Form (CRF).
Visits 2-38; 36 training sessions (3days/week) \& 3 sessions Outcome measure assessments (OM 2-4) During the intervention phase, participants will attend 3 training sessions per week for up to 12 weeks (participants may opt to withdraw from training after 4 or 8 weeks and, if they choose to withdraw, will be advanced to the follow-up phase); each session will last from 20 mins-1 hour depending on the maximum achievable endurance (plus an additional <30 mins for set-up in iCycle). Stimulation parameters will be recorded for each participant before training starts and a training diary will be completed during each training session.
During each training session
- Electrodes will be placed on the quadriceps, hamstring and gluteal muscles.
- Participants will be able to tether their wheelchair (from under the seat) to the front of the iCycle for security and hold the handlebars provided on the dashboard while cycling for further stability. These can be adjusted for comfort.
- Muscle stimulation (FES) will be applied to the leg muscles on alternative revolutions of the pedals during a virtual reality cycle race(s). The more voluntary effort the greater the speed of the avatar.
- Training will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour.
Outcome measures (OM 2-4) will be performed every 4 weeks during the intervention phase (on a separate day to training sessions). The same outcome measures conducted in the baseline phase are repeated here with the addition of an audio recorded interview conducted in the OM4 appointment.
Follow-up Phase:
Visits 39-40 - 2 sessions Outcome measures (OM 5-6) Following termination of training, no further intervention will be given. Outcome measure assessments (OM 5-6) will be performed every 4 weeks during the 8-week follow-up phase.
- Conditions
- Spinal Cord Injuries
- Being tested
- iCycle Mark 3
- Keywords
- Rehabilitation, FES cycling, Virtual Reality, Biofeedback, Motor Function
- 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.
iCycle Mark 3Device
The iCycle Mark 3 is a cycle ergometer, designed to be used by people with SCI while they are seated in their own wheelchairs. The purpose of iCycle is to stimulate the leg muscles in the correct phase for cycling while motivating the person with a Virtual Reality cycling event, perhaps a race, to try to use their muscles.
| Study group | Role | What they receive |
|---|---|---|
| iCycle training | Experimental | Participants will attend 3 training sessions per week at the RNOH. During these sessions, participants will tether their wheelchair (from under the seat) to the front of the iCycle, and their feet will be attached to the iCycle pedals. For training, participants will complete virtual reality cycle races displayed on a large screen in front of the iCycle: the more voluntary effort the participant contributes the greater the speed of the avatar. During cycling, a motor will control cycling speed, and muscle stimulation (FES) will be applied to the leg muscles (right and left gluteus, quadriceps and hamstrings) on alternative revolutions of the pedals. A dashboard screen will display controls for the stimulation, speed, brake, game switch and an emergency stop. Sessions will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour. Receives: Device: iCycle Mark 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score.
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
Measured: 15 minutes
Secondary outcomes (5)
Change in Trunk Impairment Scale (TIS) score
The TIS scores, on a range from 0 to 23, static and dynamic sitting balance as well as trunk co-ordination. It aims to score the quality of trunk movement and to be a guide for treatment.
Measured: 15 minutes
Change in Walking Index for Spinal Cord Injury (WISCI II) score
Assessment index to assess ability of walking after SCI. This is quantified using rank ordering and dimension of impairment from most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance
Measured: 15 minutes
change in 6-minute walk test (6MWT) distance
A submaximal exercise test that measures the distance walked over a span of 6 minutes
Measured: 15 minutes
Threshold of evoked responses to Transcranial Magnetic Stimulation (TMS)
TMS is used to activate the motor cortex, and motor evoked potentials (MEPs) are measured in lower limb muscles using electromyography, Threshold to elicit MEPs is measured in each muscle.
Measured: 60 minutes
Audio/transcribed feedback from participants from semi-structured interview
A semi-structured interview will be conducted to assess the participants experience in the trial, the training intervention and using the iCycle.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start6 Jan 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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 College, LondonThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902482
- Sponsor's protocol ID
- 140131
- Acronym
- iCycle
- Status last verified
- Apr 2024
- First submitted
- 7 May 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the study is only 6 participants IPD will be provided in study publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Function Through Cycling Therapy With Virtual Reality Biofeedback in Chronically Spinal Cord-injured People
- ClinicalTrials.gov ID
- NCT04902482
- Acronym / sponsor ID
- iCycle / 140131
- Conditions
- Spinal Cord Injuries
- Keywords
- Rehabilitation, FES cycling, Virtual Reality, Biofeedback, Motor Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 May 2021 (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.
The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective SCI rehabilitation is therefore increasingly important.
The iCycle combines functional electrical stimulation (FES) cycling with VR cycle-racing feedback, where winning correlates with voluntary effort, to promote recovery. The aim is to improve walking in people with incomplete injuries, fundamental to independence and quality of life as well as long-term health. More intensive rehabilitative training is associated with better outcomes: the iCycle has the potential to increase intensity of exercise without additional demands on therapists' time and therefore cost.
Following the encouraging results in an initial study; it is now important to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. Six volunteers with SCI will be recruited to participate in this 20 week, single-site open feasibility trial. The trial consists of an intervention phase lasting up to 12 weeks (3 iCycle sessions per week), and an 8-week follow-up phase. Outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test, Goal Attainment Scale and TMS) will be taken every 4 weeks. The 12-week intervention phase will be separated into three 4-week blocks; at the end of each block participants may decide whether or not they wish to continue training.
Detailed description
Recruitment:
Participants will be recruited from London Spinal Cord injuries Centre (LSCIC) at the Royal National Orthopaedic Hospital (RNOH) where the training intervention will be carried out. The study will also be advertised via relevant newsletters, bulletin boards, websites and mailing lists.
For each recruited participant, the study will be conducted for up to 20 weeks in total*. This includes: an intervention phase lasting up to 12 weeks and an 8-week follow-up phase. Outcome measure (OM) assessments will be carried out every 4 weeks (OM1-6) to collect study variables. OM assessments will be conducted by either the researcher or physiotherapist. Each OM assessment session will be broken into two parts, each lasting 2 hours.
- At the end of each 4-week block in the intervention phase, participants will be given the option to continue training for the next 4-week block, or to stop training.
Intervention Phase:
Visit 1: During first outcome measure visit (OM1), participants will attend the Aspire Create labs at the RNOH in Stanmore, where they will be given the opportunity to ask questions about the study, informed consent to participate in the study will be taken and demographic information recorded in the Case Report Form (CRF).
Visits 2-38; 36 training sessions (3days/week) \& 3 sessions Outcome measure assessments (OM 2-4) During the intervention phase, participants will attend 3 training sessions per week for up to 12 weeks (participants may opt to withdraw from training after 4 or 8 weeks and, if they choose to withdraw, will be advanced to the follow-up phase); each session will last from 20 mins-1 hour depending on the maximum achievable endurance (plus an additional <30 mins for set-up in iCycle). Stimulation parameters will be recorded for each participant before training starts and a training diary will be completed during each training session.
During each training session
- Electrodes will be placed on the quadriceps, hamstring and gluteal muscles.
- Participants will be able to tether their wheelchair (from under the seat) to the front of the iCycle for security and hold the handlebars provided on the dashboard while cycling for further stability. These can be adjusted for comfort.
- Muscle stimulation (FES) will be applied to the leg muscles on alternative revolutions of the pedals during a virtual reality cycle race(s). The more voluntary effort the greater the speed of the avatar.
- Training will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour.
Outcome measures (OM 2-4) will be performed every 4 weeks during the intervention phase (on a separate day to training sessions). The same outcome measures conducted in the baseline phase are repeated here with the addition of an audio recorded interview conducted in the OM4 appointment.
Follow-up Phase:
Visits 39-40 - 2 sessions Outcome measures (OM 5-6) Following termination of training, no further intervention will be given. Outcome measure assessments (OM 5-6) will be performed every 4 weeks during the 8-week follow-up phase.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCycle training | Experimental | Device: iCycle Mark 3Participants will attend 3 training sessions per week at the RNOH. During these sessions, participants will tether their wheelchair (from under the seat) to the front of the iCycle, and their feet will be attached to the iCycle pedals. For training, participants will complete virtual reality cycle races displayed on a large screen in front of the iCycle: the more voluntary effort the participant contributes the greater the speed of the avatar. During cycling, a motor will control cycling speed, and muscle stimulation (FES) will be applied to the leg muscles (right and left gluteus, quadriceps and hamstrings) on alternative revolutions of the pedals. A dashboard screen will display controls for the stimulation, speed, brake, game switch and an emergency stop. Sessions will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years
- Incomplete SCI above T12
- >12 months post injury
- Respond to FES
- No deteriorating condition or other co-morbidity that would make participation impractical or unsafe.
Key exclusion criteria (16 listed)
- Cardiac pacemaker
- Pressure sores/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 |
|---|---|---|
| iCycle Mark 3The iCycle Mark 3 is a cycle ergometer, designed to be used by people with SCI while they are seated in their own wheelchairs. The purpose of iCycle is to stimulate the leg muscles in the correct phase for cycling while motivating the person with a Virtual Reality cycling event, perhaps a race, to try to use their muscles. | Device | iCycle training |
Primary outcome
Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score.
Time frame: 15 minutes
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
5 secondary outcomes
Change in Trunk Impairment Scale (TIS) score
Time frame: 15 minutes
Change in Walking Index for Spinal Cord Injury (WISCI II) score
Time frame: 15 minutes
change in 6-minute walk test (6MWT) distance
Time frame: 15 minutes
Threshold of evoked responses to Transcranial Magnetic Stimulation (TMS)
Time frame: 60 minutes
Audio/transcribed feedback from participants from semi-structured interview
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No. As the study is only 6 participants IPD will be provided in study publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCycle Mark 3 in people with Spinal Cord Injuries, run by University College, London at 1 site in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score. (time frame: 15 minutes). 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 26 Apr 2024.