Acute Spinal Cord InjuryNCT05255679
Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery
A study testing Early FES and Delayed FES in people with Acute Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
Trial summary
Spinal cord injury (SCI) is a devastating condition that often leads to paralysis and multiple health problems such as muscle wasting, bone loss and spasticity. Despite the paralysis, functional electrical stimulation (FES) on the skin surface muscles may produce muscle contractions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Early FES and Delayed FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2021to 31 Oct 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non-traumatic SCI
- Acute onset of SCI
- Able to start FES cycling 14-21 days post injury
- Injury level C1 - L5
- AIS A, B, C, D (ASIA Impairment Scale)
- Medically stable
Show all 33Show fewer
- Absolute Contraindications and Exclusion Criteria
- AIS D, able to walk without assistive device
- Unstable spine fractures
- Unstable fractures/dislocations in lower extremities or pelvis
- Pregnancy
- Unable to give consent to participate in the study
- Contraindications for TMS (Transcranial Magnetic Stimulation).
- Relative Contraindications and Exclusion Criteria (Exclusion or Caution)
- Lower motor neuron injury with insufficient muscle contraction with FES
- Peripheral nerve or root injury resulting in denervated lower limb muscles
- History of severe hip or knee instability or dislocation/subluxation
- Osteoporosis in lower extremities that could result in fracture from cycling
- Osteoarthritis in lower extremities
- Limited range of motion in hip and knee preventing cycling
- History of epilepsy not effectively managed by medication
- History of heart problems (coronary artery disease / myocardial infarction / congestive heart failure)
- Implanted cardiac demand pacemaker
- Implanted stimulators: diaphragmatic, epidural, vagus nerve, phrenic
- Malignant tumor in stimulated areas
- Thrombophlebitis or thrombosis in stimulated area
- Skin lesions or open wounds at any potential electrode site
- Pressure ulcers that could deteriorate from cycling
- Spasticity
- Autonomic dysreflexia
- Active heterotopic ossification in lower extremities
- Extreme edema or adipose tissue in legs
- Any other contraindications to participate in an active exercise program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Effect of Early FES Cycling After Acute Spinal Cord Injury on Neuromuscular Preservation and Neurorecovery
Spinal cord injury (SCI) is a devastating condition that often leads to paralysis and multiple health problems such as muscle wasting, bone loss and spasticity. Despite the paralysis, functional electrical stimulation (FES) on the skin surface muscles may produce muscle contractions. People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans. Therefore, the investigators propose to study if early FES cycling could prevent muscle wasting, pain or spasticity, and help with spinal cord recovery.
The study will recruit 36 participants with a new, acute SCI, between 14 and 21 days after their injury into 3 groups. An Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling.
This pilot study will allow us to study if early FES cycling, in addition to normal care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than delayed FES cycling or standard care only. The results of this pilot study may lead to the development of a larger study with early FES cycling after new SCI.
Read the detailed description
Spinal cord injury (SCI) usually results in weakness or paralysis in the legs and/or arms, depending on the level and severity of the damage to the spinal cord. In addition, people with SCI often develop several complications in the long term, such as muscle wasting (atrophy), loss of bone strength, pain, and spasticity.
Despite the weakness or paralysis, the muscles in a person with SCI can be activated using electrical stimulation applied on the skin surface of the muscles. This technique is called functional electrical stimulation (FES) and can be used in combination with a bike to perform a cycling movement (FES cycling). People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans, for example, if it could prevent muscle atrophy, pain or spasticity, and help with recovery of the spinal cord. Therefore, the investigators propose to study if early FES cycling may prevent these complications and help with spinal cord recovery.
The study will recruit 36 participants with a new SCI, in 3 groups. The Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling. People with an acute, complete or incomplete SCI that resulted in paralysis from the waist down (paraplegia) or neck down (quadriplegia) will be considered. The Early and Delayed FES group will be recruited from the University of Alberta Hospital (UAH) where the FES bikes are available. Participants will be assigned by chance into Early and Delayed FES group. The control group will be mainly recruited from the Royal Alexandra Hospital, where the FES bikes are currently not available. The FES groups will perform FES cycling sessions 3 times per week (up to 1 hour per session) and receive standard care (typically including physical and occupational therapy). The Control group will only receive standard care.
The FES cycling will be performed while the participants are lying in bed using a bed bike, or while sitting in a wheel chair using chair-based bike. Both systems use pedals that are strapped to the feet and an electrical stimulator to activate several muscles of both legs using electrodes attached to the skin.
The following will be measured: 1) the size of the leg muscles and amount of fat in the legs using a CT scanner. 2) strength of the muscles using manual tests and by the electrical signals in the muscle. 3) spasticity by measuring electrical responses in the muscle when stimulated, as well as with clinical scales. 4) strength of the electrical connections between brain and spinal cord. 5) clinical measures such as the spinal injury classification, pain and reflexes. 6) response of participants to the FES cycling program. 7) cost and health care resources for the administration of early and delayed FES cycling. All 3 groups will undergo the same assessments.
This pilot study will allow the investigators to study if early FES cycling, in addition to standard care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than standard care only. The results of this pilot study may lead to the development of a multi-center clinical trial with early FES cycling after new SCI, which may have important and innovative implications in the future rehabilitation practice, improving the health, function and quality of life of persons with SCI.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Early FES, Delayed FES
- Keywords
- spinal cord injury, functional electrical stimulation, muscle mass, spasticity, neurorecovery
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early FESDevice
FES cycling starting 14-21 days post SCI for 6 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD)
Delayed FESDevice
FES cycling starting 3 months (+ 14-21 days) post SCI, for 3 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD)
| Study group | Role | What they receive |
|---|---|---|
| Early FES | Experimental | Receives standard care plus FES cycling in Phase 1 (starting 14 to 21 days after injury and for 3 months) and Phase 2 (from month 3 to month 6 after enrollment). Receives: Device: Early FES |
| Delayed FES | Experimental | Receives standard care only in Phase 1 (considered Control group in Phase 1), and standard care plus FES cycling in Phase 2 (from month 3 to month 6 after enrollment). Receives: Device: Delayed FES |
| Control | No intervention | Receives standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle cross-sectional area thigh and calf: Change from 0 to 3 months
Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf
Measured: 3 months
Muscle cross-sectional area thigh and calf: Change from 3 months to 6 months
Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf
Measured: 3 months
Spasticity legs: Change from 0 to 3 months
Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).
Measured: 3 months
Spasticity legs: Change from 3 months to 6 months
Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).
Measured: 3 months
Corticospinal excitability: Change from 0 to 3 months
Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).
Measured: 3 months
Corticospinal excitability: Change from 3 months to 6 months
Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).
Measured: 3 months
Spinal cord excitability: Change from 0 to 3 months
Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)
Measured: 3 months
Spinal cord excitability: Change from 3 months to 6 months
Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)
Measured: 3 months
Muscle strength: Change from 0 to 3 months
Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.
Measured: 3 months
Muscle strength: Change from 3 months to 6 months
Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.
Measured: 3 months
Secondary outcomes (22)
SCI Classification at Baseline
Spinal cord injury classification based on the American Spinal Injury Association (ASIA) Injury Scale (AIS), according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range AIS A, B, C, D (most-least severe injury)
Measured: Baseline
SCI Classification at 3 months
Spinal cord injury classification based on the American Spinal Injury Association (ASIA) Injury Scale (AIS), according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range AIS A, B, C, D (most-least severe injury)
Measured: 3 months
SCI Classification at 6 months
Spinal cord injury classification based on the American Spinal Injury Association (ASIA) Injury Scale (AIS), according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range AIS A, B, C, D (most-least severe injury)
Measured: 6 months
Motor scores: Change from 0 to 3 months
Sum of motor scores based on manual muscle strength testing of 5 key upper limb and 5 key lower limb muscle groups bilaterally according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range worst-best score 0-100.
Measured: 3 months
Motor scores: Change from 3 months to 6 months
Sum of motor scores based on manual muscle strength testing of 5 key upper limb and 5 key lower limb muscle groups bilaterally according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range worst-best score 0-100.
Measured: 3 months
Sensory scores: Change from 0 to 3 months
Sum of sensory scores in response to light touch and pinprick at 28 key sensory points on each side of the whole body, according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range worst-best score 0-224.
Measured: 3 months
Sensory scores: Change from 3 months to 6 months
Sum of sensory scores in response to light touch and pinprick at 28 key sensory points on each side of the whole body, according to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Range worst-best score 0-224.
Measured: 3 months
Pain intensity: Change from 0 to 3 months
Pain intensity assessment using the International Spinal Cord Injury Pain Basic Data Set v2. The tool scores intensity using an 11-point numeric scale (Range best-worst score 0-10). In addition the tool describes pain over the previous 7 days, impact of pain, type of pain (nociceptive vs. neuropathic), intensity and duration of pain, and treatment for pain.
Measured: 3 months
Pain intensity: Change from 3 months to 6 months
Pain intensity assessment using the International Spinal Cord Injury Pain Basic Data Set v2. The tool scores intensity using an 11-point numeric scale (Range best-worst score 0-10). In addition the tool describes pain over the previous 7 days, impact of pain, type of pain (nociceptive vs. neuropathic), intensity and duration of pain, and treatment for pain.
Measured: 3 months
Leg cross-sectional area thigh and calf: Change from 0 to 3 months
Leg cross-sectional area calculated based on circumferences of thigh and calf measured with tape measure, and corrected for skinfold thickness (measure of subcutaneous fat) measured with skinfold caliper at same locations.
Measured: 3 months
Leg cross-sectional area thigh and calf: Change from 3 months to 6 months
Leg cross-sectional area calculated based on circumferences of thigh and calf measured with tape measure, and corrected for skinfold thickness (measure of subcutaneous fat) measured with skinfold caliper at same locations.
Measured: 3 months
Walking Speed: Change from 0 to 3 months
Depending in the participant's capabilities, walking speed will be assessed with the 10-meter walking test (measuring time taken to walk 10 meters), and/or the 6-minute walking test (measuring distance walked in 6 minutes)
Measured: 3 months
Walking Speed: Change from 3 months to 6 months
Depending in the participant's capabilities, walking speed will be assessed with the 10-meter walking test (measuring time taken to walk 10 meters), and/or the 6-minute walking test (measuring distance walked in 6 minutes)
Measured: 3 months
Walking Capability: Change from 0 to 3 months
Scored using the Walking Index for Spinal Cord Injury (WISCI II), giving a ranking from most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons.
Measured: 3 months
Walking Capability: Change from 3 months to 6 months
Scored using the Walking Index for Spinal Cord Injury (WISCI II), giving a ranking from most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons.
Measured: 3 months
Spasticity self-report: Change from 0 to 3 months
Frequency and severity of the spasticity, its interference with function, and association with pain, scored using 11-point numeric scales. Range 0-10, with best (0) to worst (10).
Measured: 3 months
Spasticity self-report: Change from 3 months to 6 months
Frequency and severity of the spasticity, its interference with function, and association with pain, scored using 11-point numeric scales. Range 0-10, with best (0) to worst score (10).
Measured: 3 months
Depression at 3 months
Total score derived from the Patient Health Questionnaire (PHQ-9 ) which includes 9 questions related to signs of depression. Range best-worst score 0-27.
Measured: 3 months
Depression at 6 months
Total score derived from the Patient Health Questionnaire (PHQ-9 ) which includes 9 questions related to signs of depression. Range best-worst score 0-27.
Measured: 6 months
Psychosocial status of participants as assessed by AQol-8D at 3 months
Total score derived from the Assessment of Quality of Life (AQol-8D), measuring 8 dimensions of quality of life. Range worst-best score 35-176.
Score derived from EQ-5D-5L Quality of Life Tool (EuroQol Research Foundation), measuring 5 dimensions. Range best-worst score 5-25.
Measured: 3 months
Psychosocial status of participants as assessed by AQol-8D at 6 months
Total score derived from the Assessment of Quality of Life (AQol-8D), measuring 8 dimensions of quality of life. Range worst-best score 35-176.
Score derived from EQ-5D-5L Quality of Life Tool (EuroQol Research Foundation), measuring 5 dimensions. Range best-worst score 5-25.
Measured: 6 months
Program Cost
Cost and health care resources for the administration of early and delayed FES
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start21 Apr 2021
- Primary completion30 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized control group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital, Glenrose Foundation
- Responsible party
- Sponsor
- Investigators
- Chester Ho, MD, Principal investigator, University of AlbertaMonica A Gorassini, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255679
- Sponsor's protocol ID
- Pro00100619
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of Early FES Cycling After Acute Spinal Cord Injury on Neuromuscular Preservation and Neurorecovery
- ClinicalTrials.gov ID
- NCT05255679
- Acronym / sponsor ID
- Pro00100619
- Conditions
- Acute Spinal Cord Injury
- Keywords
- spinal cord injury, functional electrical stimulation, muscle mass, spasticity, neurorecovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital, Glenrose Foundation
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Feb 2022 (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 condition that often leads to paralysis and multiple health problems such as muscle wasting, bone loss and spasticity. Despite the paralysis, functional electrical stimulation (FES) on the skin surface muscles may produce muscle contractions. People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans. Therefore, the investigators propose to study if early FES cycling could prevent muscle wasting, pain or spasticity, and help with spinal cord recovery.
The study will recruit 36 participants with a new, acute SCI, between 14 and 21 days after their injury into 3 groups. An Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling.
This pilot study will allow us to study if early FES cycling, in addition to normal care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than delayed FES cycling or standard care only. The results of this pilot study may lead to the development of a larger study with early FES cycling after new SCI.
Detailed description
Spinal cord injury (SCI) usually results in weakness or paralysis in the legs and/or arms, depending on the level and severity of the damage to the spinal cord. In addition, people with SCI often develop several complications in the long term, such as muscle wasting (atrophy), loss of bone strength, pain, and spasticity.
Despite the weakness or paralysis, the muscles in a person with SCI can be activated using electrical stimulation applied on the skin surface of the muscles. This technique is called functional electrical stimulation (FES) and can be used in combination with a bike to perform a cycling movement (FES cycling). People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans, for example, if it could prevent muscle atrophy, pain or spasticity, and help with recovery of the spinal cord. Therefore, the investigators propose to study if early FES cycling may prevent these complications and help with spinal cord recovery.
The study will recruit 36 participants with a new SCI, in 3 groups. The Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling. People with an acute, complete or incomplete SCI that resulted in paralysis from the waist down (paraplegia) or neck down (quadriplegia) will be considered. The Early and Delayed FES group will be recruited from the University of Alberta Hospital (UAH) where the FES bikes are available. Participants will be assigned by chance into Early and Delayed FES group. The control group will be mainly recruited from the Royal Alexandra Hospital, where the FES bikes are currently not available. The FES groups will perform FES cycling sessions 3 times per week (up to 1 hour per session) and receive standard care (typically including physical and occupational therapy). The Control group will only receive standard care.
The FES cycling will be performed while the participants are lying in bed using a bed bike, or while sitting in a wheel chair using chair-based bike. Both systems use pedals that are strapped to the feet and an electrical stimulator to activate several muscles of both legs using electrodes attached to the skin.
The following will be measured: 1) the size of the leg muscles and amount of fat in the legs using a CT scanner. 2) strength of the muscles using manual tests and by the electrical signals in the muscle. 3) spasticity by measuring electrical responses in the muscle when stimulated, as well as with clinical scales. 4) strength of the electrical connections between brain and spinal cord. 5) clinical measures such as the spinal injury classification, pain and reflexes. 6) response of participants to the FES cycling program. 7) cost and health care resources for the administration of early and delayed FES cycling. All 3 groups will undergo the same assessments.
This pilot study will allow the investigators to study if early FES cycling, in addition to standard care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than standard care only. The results of this pilot study may lead to the development of a multi-center clinical trial with early FES cycling after new SCI, which may have important and innovative implications in the future rehabilitation practice, improving the health, function and quality of life of persons with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Non-randomized control group design
| Arm | Type | Receives |
|---|---|---|
| Early FES | Experimental | Device: Early FESReceives standard care plus FES cycling in Phase 1 (starting 14 to 21 days after injury and for 3 months) and Phase 2 (from month 3 to month 6 after enrollment). |
| Delayed FES | Experimental | Device: Delayed FESReceives standard care only in Phase 1 (considered Control group in Phase 1), and standard care plus FES cycling in Phase 2 (from month 3 to month 6 after enrollment). |
| Control | No intervention | –Receives standard care only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Traumatic or non-traumatic SCI
- Acute onset of SCI
- Able to start FES cycling 14-21 days post injury
- Injury level C1 - L5
- AIS A, B, C, D (ASIA Impairment Scale)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Early FESFES cycling starting 14-21 days post SCI for 6 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD) | Device | Early FES |
| Delayed FESFES cycling starting 3 months (+ 14-21 days) post SCI, for 3 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD) | Device | Delayed FES |
Primary outcome
Muscle cross-sectional area thigh and calf: Change from 0 to 3 months
Time frame: 3 months
Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf
Muscle cross-sectional area thigh and calf: Change from 3 months to 6 months
Time frame: 3 months
Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf
Spasticity legs: Change from 0 to 3 months
Time frame: 3 months
Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).
Spasticity legs: Change from 3 months to 6 months
Time frame: 3 months
Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).
Corticospinal excitability: Change from 0 to 3 months
Time frame: 3 months
Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).
Corticospinal excitability: Change from 3 months to 6 months
Time frame: 3 months
Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).
Spinal cord excitability: Change from 0 to 3 months
Time frame: 3 months
Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)
Spinal cord excitability: Change from 3 months to 6 months
Time frame: 3 months
Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)
Muscle strength: Change from 0 to 3 months
Time frame: 3 months
Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.
Muscle strength: Change from 3 months to 6 months
Time frame: 3 months
Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.
22 secondary outcomes
SCI Classification at Baseline
Time frame: Baseline
SCI Classification at 3 months
Time frame: 3 months
SCI Classification at 6 months
Time frame: 6 months
Motor scores: Change from 0 to 3 months
Time frame: 3 months
Motor scores: Change from 3 months to 6 months
Time frame: 3 months
Sensory scores: Change from 0 to 3 months
Time frame: 3 months
Sensory scores: Change from 3 months to 6 months
Time frame: 3 months
Pain intensity: Change from 0 to 3 months
Time frame: 3 months
Pain intensity: Change from 3 months to 6 months
Time frame: 3 months
Leg cross-sectional area thigh and calf: Change from 0 to 3 months
Time frame: 3 months
Leg cross-sectional area thigh and calf: Change from 3 months to 6 months
Time frame: 3 months
Walking Speed: Change from 0 to 3 months
Time frame: 3 months
Walking Speed: Change from 3 months to 6 months
Time frame: 3 months
Walking Capability: Change from 0 to 3 months
Time frame: 3 months
Walking Capability: Change from 3 months to 6 months
Time frame: 3 months
Spasticity self-report: Change from 0 to 3 months
Time frame: 3 months
Spasticity self-report: Change from 3 months to 6 months
Time frame: 3 months
Depression at 3 months
Time frame: 3 months
Depression at 6 months
Time frame: 6 months
Psychosocial status of participants as assessed by AQol-8D at 3 months
Time frame: 3 months
Psychosocial status of participants as assessed by AQol-8D at 6 months
Time frame: 6 months
Program Cost
Time frame: 6 months
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 19 Sep 2024.
- 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.
Chester Ho, MD principal investigator
University of Alberta
Monica A Gorassini, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early FES and Delayed FES in people with Acute Spinal Cord Injury, run by University of Alberta 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 33 inclusion and 0 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 19 Sep 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 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?
Muscle cross-sectional area thigh and calf: Change from 0 to 3 months (time frame: 3 months). The study lists 10 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 19 Sep 2024.