Spinal Cord Injury, AcuteNCT04064385
Functional Electrical Stimulation Cycling in SCI
A study testing FES Cycling in people with Spinal Cord Injury, Acute and Paraplegia, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to exercise and address the long-term consequences of SCI by targeting the lower extremity muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Acute, Paraplegia, Tetraplegia
- What is being tested?
- FES Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2019to Jul 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
- identified as being medically stable by the treating consultant,
- within the first 6 weeks post-injury,
- able to sit for 2 hours in a wheelchair,
- over 18 years old,
- acquired non progressive SCI - traumatic, spinal cord stroke, surgical injury,
- an incomplete SCI, graded as American Spinal Injury Association (ASIA) B (motor complete, sensation present below the lesion); C (some but not useful motor function) or D (useful motor function present),
Who cannot join
- acute condition impairing participant's ability to cycle (eg, leg fracture),
- proven or suspected neuromuscular weakness affecting the legs due to another condition (eg, stroke or Guillain-Barré syndrome),
- unable to follow instruction in English
- symptomatic cardiac disease,
- ventilator dependency,
- severe spasticity,
Show all 10Show fewer
- uncontrolled autonomic dysreflexia,
- possible, suspected or confirmed pregnancy,
- likely to be discharged before the end of the exercise intervention.
- unable to tolerate the sensation of FES
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Queen Elizabeth National Spinal Injuries Unit
Glasgow, G51 4TF
Mariel Purcell, MB, 0141 201 2536, Margaret.Purcell@ggc.scot.nhs.uk
Claire Lincoln, MSc
About this study
Official title: Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study
Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to exercise and address the long-term consequences of SCI by targeting the lower extremity muscles. Cycling with the addition of functional electrical stimulation (FES) allows persons with paralysis to exercise their paretic or paralysed leg muscles. The Queen Elizabeth National Spinal Injury Unit (QENSIU) in Glasgow offers FES cycling for people with spinal cord injuries, which combines functional electrical stimulation (FES) with a motorised ergometer that allows repetitive cycling activity. It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. So far no previous randomised control trials on FES cycling in the acute SCI population have reported changes in ability to undertake activities of daily living or the trunk balance.
Read the detailed description
Up to 12 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention (n=8) or control group (n=4). The intervention group will receive 6 weeks FES cycling training in addition to usual care; the control group will receive usual care only. Outcome measures: Spinal Cord Injury Functional Ambulation Inventory, The Spinal Cord Independence Measure, ASIA Impairment Scale, Handheld dynamometry, 10-Metre Walking Test, Timed Up and Go Test, Trunk Impairment Scale, Modified Ashworth scale, Modified Tardieu Scale, the Patients Global Impression of Change.
- Conditions
- Spinal Cord Injury, Acute, Paraplegia, Tetraplegia
- Being tested
- FES Cycling
- Keywords
- Functional Electrical Stimulation Cycling, Physical Therapy
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES CyclingDevice
Stimulation parameters will be 450μs, 40Hz, and up to 140mA, these values will be changed if needed based on individual response. For example, stimulation to the gluteal muscles often may to be decreased to prevent autonomic dysreflexia. To receive correct stimulation parameters, stimulation intensity will be chosen to ensure a palpable muscle contraction and sensor tolerance. Each session will include a 2-minute warm-up and 2-minute cool-down of passive cycling. The unit automatically delivers enough stimulation to maintain a speed of 30 rotations per minute (rpm). Where this is not achieved, the leg cycle will assist the stimulated movement to maintain a speed of 30 rpm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | FES cycle training will be performed on the RT300 FES cycle ideally 3 times per week for 6 weeks, each session lasting up to 90 minutes. Electrical stimulation will be delivered through up to 12 independent channels each delivering up to 140 mA current on the following muscles (both on the right and left leg): quadriceps, femoral biceps and gluteus, gastrocnemius and tibialis anterior. Abdominal and back extensor muscles may also be stimulated if the participant presents with neurological trunk weakness (SCI above T6). The FES unit will stimulate the muscles that extend the hip (gluteals), flex the knee (hamstrings) and extend the knee (quadriceps) in the correct order to bring about a cycling motion. The feet and lower legs of the participants will be strapped into the pedals and the wheelchair will be coupled in a rigid manner with the training device. Receives: Device: FES Cycling |
| Control | No intervention | Participants in the control group will receive usual care, consistent with standard NHS care in this population. Usual physiotherapy care is provided, up to 2 times per day, 4 to 5 days per week, each lasting approximately 90 minutes. Physiotherapists provide one to one function-oriented physiotherapy session to improve balance, muscle strength and transfer skills. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)
It consists of three components: gait parameter, assistive device use and walking ability. The gait parameter component is scored out of 20, 10 points for each of the right and left sides. The assistive device component is scored out of 14 (7 points for each side), and assesses upper and lower extremities in addition to the left and right limbs. Scores within each component are summed. Component scores range from 0 to 20 in the gait parameter component, 0 to 14 in the assistive device component, and 0 to 5 in the walking mobility component. The SCI-FAI is a reliable, valid and sensitive measure of walking ability in individuals with spinal cord injury.
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (9)
The Spinal Cord Independence Measure (SCIM III)
composed of 19 items that assesses 3 domains: self-care, respiration and sphincter management and mobility. The total SCIM scores range from 0 to 100.
Measured: baseline, 6 weeks, 12 weeks
ASIA Impairment Scale
The ASIA impairment scale classifies motor and sensory impairment that results from a spinal cord injury. It divides spinal cord injuries into 5 categories: A-E. A- Complete - No motor or sensory function in the lowest sacral segment (S4-S5). B- Incomplete - Sensory function below neurologic level and in S4-S5, no motor function below neurologic level. C- Incomplete - Motor function is preserved below neurologic level and more than half of the key muscle groups below neurologic level have a muscle grade less than 3. D- Incomplete - Motor function is preserved below neurologic level and at least half of the key muscle groups below the neurologic level have a muscle grade >3. E- Normal - Sensory and motor function is normal
Measured: baseline, 6 weeks, 12 weeks
Handheld dynamometry (HDD)
will be used to quantify the strength of the knee extensors, knee flexors, hip flexors, hip abductors, and ankle plantar flexors of both legs. The order of testing will be constant across testing sessions and position of patient and assessor standardised. Three trials will be performed on each muscle group. Prevention of muscle fatigue will be achieved by a 30-second recovery period after each trial and 2 minutes of rest between evaluations of the muscle groups. One or 2 trials will be used to familiarize the participants with the testing procedures before the actual strength measurements of each muscle group.
Measured: baseline, 6 weeks, 12 weeks
10-Metre Walking Test (10MWT)
The total marked distance will be 14 meters and, to allow for acceleration and deceleration, participants will be timed over the middle 10 meters. Participants will walk the distance twice and the average of 2 trials will be measured. They will be asked to walk the distance as fast and safely as possible. The participant should perform this test with their assistive devices as appropriate.
Measured: baseline, 6 weeks, 12 weeks
Timed Up and Go (TUG) Test
assesses mobility, balance, walking ability and falls risk. It measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Measured: baseline, 6 weeks, 12 weeks
Trunk Impairment Scale (TIS)
is a 17-item measure for assessing the level of motor impairment of the trunk e.g. coordination and sitting balance (static and dynamic). The scores range from 0 to 23 with lower scores indicating high levels of motor deficit in the trunk
Measured: baseline, 6 weeks, 12 weeks
Modified Ashworth scale (MAS)
is a scale used to measure the level of spasticity in people with neurological conditions (ASHWORTH 1964). The MAS scores range from 0 to 4, with higher scores indicating an increase in muscle tone.
0 No increase in muscle tone.
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM.
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3 Considerable increase in muscle tone, passive movement difficult. 4 Affected part(s) rigid in flexion or extension
Measured: baseline, 6 weeks, 12 weeks
Modified Tardieu Scale (MTS)
the MTS is a valid, reliable scale for measure the level of spasticity in patient with neurological conditions (Li, Wu, and Xiong 2014). Akpinar et al. (Akpinar et al. 2017) suggests its utility as a complementary tool when assessing spasticity in SCI patients. The MTS assesses the response of the muscle to different velocities of stretch in terms of quality and angle of the muscle tested. In terms of quality of muscle reaction, the score ranges from 0 to 5, where a score of 0 means that the muscle is not spastic while a score of 5 means that the muscle is spastic and immobile. In terms of angle of muscle reaction, the score is R1 or R2, where R1 means the joint demonstrates limited passive range of motion while R2 means the joint demonstrate full passive range of motion.
Measured: baseline, 6 weeks, 12 weeks
the Patients Global Impression of Change
PGIC is a 7-point, patient reported scale which evaluates all aspects of the patients' health and assesses if there has been an improvement or decline in clinical status. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse"
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jun 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Aleksandra Dybus, Glasgow Caledonian University
- Investigators
- Aleksandra Dybus, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064385
- Sponsor's protocol ID
- GN19NE123
- Status last verified
- Aug 2019
- First submitted
- 4 Jul 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study
- ClinicalTrials.gov ID
- NCT04064385
- Acronym / sponsor ID
- GN19NE123
- Conditions
- Spinal Cord Injury, Acute, Paraplegia, Tetraplegia
- Keywords
- Functional Electrical Stimulation Cycling, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Aug 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.
Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to exercise and address the long-term consequences of SCI by targeting the lower extremity muscles. Cycling with the addition of functional electrical stimulation (FES) allows persons with paralysis to exercise their paretic or paralysed leg muscles. The Queen Elizabeth National Spinal Injury Unit (QENSIU) in Glasgow offers FES cycling for people with spinal cord injuries, which combines functional electrical stimulation (FES) with a motorised ergometer that allows repetitive cycling activity. It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. So far no previous randomised control trials on FES cycling in the acute SCI population have reported changes in ability to undertake activities of daily living or the trunk balance.
Detailed description
Up to 12 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention (n=8) or control group (n=4). The intervention group will receive 6 weeks FES cycling training in addition to usual care; the control group will receive usual care only. Outcome measures: Spinal Cord Injury Functional Ambulation Inventory, The Spinal Cord Independence Measure, ASIA Impairment Scale, Handheld dynamometry, 10-Metre Walking Test, Timed Up and Go Test, Trunk Impairment Scale, Modified Ashworth scale, Modified Tardieu Scale, the Patients Global Impression of Change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FES CyclingFES cycle training will be performed on the RT300 FES cycle ideally 3 times per week for 6 weeks, each session lasting up to 90 minutes. Electrical stimulation will be delivered through up to 12 independent channels each delivering up to 140 mA current on the following muscles (both on the right and left leg): quadriceps, femoral biceps and gluteus, gastrocnemius and tibialis anterior. Abdominal and back extensor muscles may also be stimulated if the participant presents with neurological trunk weakness (SCI above T6). The FES unit will stimulate the muscles that extend the hip (gluteals), flex the knee (hamstrings) and extend the knee (quadriceps) in the correct order to bring about a cycling motion. The feet and lower legs of the participants will be strapped into the pedals and the wheelchair will be coupled in a rigid manner with the training device. |
| Control | No intervention | –Participants in the control group will receive usual care, consistent with standard NHS care in this population. Usual physiotherapy care is provided, up to 2 times per day, 4 to 5 days per week, each lasting approximately 90 minutes. Physiotherapists provide one to one function-oriented physiotherapy session to improve balance, muscle strength and transfer skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identified as being medically stable by the treating consultant,
- within the first 6 weeks post-injury,
- able to sit for 2 hours in a wheelchair,
- over 18 years old,
- acquired non progressive SCI - traumatic, spinal cord stroke, surgical injury,
Key exclusion criteria (10 listed)
- acute condition impairing participant's ability to cycle (eg, leg fracture),
- proven or suspected neuromuscular weakness affecting the legs due to another condition (eg, stroke or Guillain-Barré syndrome),
- unable to follow instruction in English
- symptomatic cardiac disease,
- ventilator dependency,
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 |
|---|---|---|
| FES CyclingStimulation parameters will be 450μs, 40Hz, and up to 140mA, these values will be changed if needed based on individual response. For example, stimulation to the gluteal muscles often may to be decreased to prevent autonomic dysreflexia. To receive correct stimulation parameters, stimulation intensity will be chosen to ensure a palpable muscle contraction and sensor tolerance. Each session will include a 2-minute warm-up and 2-minute cool-down of passive cycling. The unit automatically delivers enough stimulation to maintain a speed of 30 rotations per minute (rpm). Where this is not achieved, the leg cycle will assist the stimulated movement to maintain a speed of 30 rpm. | Device | Intervention |
Primary outcome
Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)
Time frame: baseline, 6 weeks, 12 weeks
It consists of three components: gait parameter, assistive device use and walking ability. The gait parameter component is scored out of 20, 10 points for each of the right and left sides. The assistive device component is scored out of 14 (7 points for each side), and assesses upper and lower extremities in addition to the left and right limbs. Scores within each component are summed. Component scores range from 0 to 20 in the gait parameter component, 0 to 14 in the assistive device component, and 0 to 5 in the walking mobility component. The SCI-FAI is a reliable, valid and sensitive measure of walking ability in individuals with spinal cord injury.
9 secondary outcomes
The Spinal Cord Independence Measure (SCIM III)
Time frame: baseline, 6 weeks, 12 weeks
ASIA Impairment Scale
Time frame: baseline, 6 weeks, 12 weeks
Handheld dynamometry (HDD)
Time frame: baseline, 6 weeks, 12 weeks
10-Metre Walking Test (10MWT)
Time frame: baseline, 6 weeks, 12 weeks
Timed Up and Go (TUG) Test
Time frame: baseline, 6 weeks, 12 weeks
Trunk Impairment Scale (TIS)
Time frame: baseline, 6 weeks, 12 weeks
Modified Ashworth scale (MAS)
Time frame: baseline, 6 weeks, 12 weeks
Modified Tardieu Scale (MTS)
Time frame: baseline, 6 weeks, 12 weeks
the Patients Global Impression of Change
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Aleksandra Dybus, PhD principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Cycling in people with Spinal Cord Injury, Acute and Paraplegia, run by Glasgow Caledonian University 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 10 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 21 Aug 2019. 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?
Contact Aleksandra Dybus, PhD (01412327888, aleksandra.dybus@gcu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI) (time frame: baseline, 6 weeks, 12 weeks). 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 21 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.