Spinal Cord InjuryNCT06873776
Arm and Leg Cycling for Accelerated SCI Recovery
A study testing A&L cycling and Body weight supported treadmill training (BWSTT) in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to examine interventions with paradigms involving upper and lower extremity cycling (A\&L cycling) with A\&L cycling with functional electrical stimulation (FES) (A\&L_FES group), A\&L cycling with FES and transcutaneous Spinal Cord Stimulation (A\&L_tSCS group), and control Body Weight… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- A&L cycling and Body weight supported treadmill training (BWSTT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non-traumatic SCI T11 and above (upper motorneuron lesion)
- Incomplete paraplegia or tetraplegia (Classified as AIS C or D)
- Age range 18-75 years old, inclusive
- At least 1 year post- injury
- Independent ambulator (with normal assistive devices or bracing) for at least 10 meters (30 feet)
- Walking speed <0.8 m/s (2.62 ft/s) (or per researcher discretion)
Show all 9Show fewer
- Bilateral arm strength to arm cycle at least 15 minutes without assistance (or per researcher discretion)
- No concurrent or planned surgeries, significant medical treatments, or therapy during the study period
- Able to understand and speak English
Who cannot join
- SCI T12 and below (or lacking upper motorneuron injury)
- Complete paraplegia or tetraplegia (classified as AIS A)
- AIS B incomplete paraplegia or tetraplegia
- Presence of progressive neurologic disease
- Unable to give informed consent to participate in the study
- Significant other disease (ex: cardiological or heart disease, renal, hepatic, malignant tumors, mental or psychiatric disorders) that would prevent participants from fullym engaging in study procedures
Show all 25Show fewer
- Weight over 160 kg (352 lbs)
- TMS contraindications
- Epilepsy, seizure disorder, or any other type of seizure history
- Medications that increase the risk of seizures
- Metal or metal fragments in the head (plates, screws, etc.)
- Surgical clips in the head or previous neurosurgery
- Implants in the head (ex: cochlear implants)
- Non-prescribed drug or marijuana use
- Depression, antidepressant medications, or antipsychotic medications
- FES and tSCS contraindications
- Active Deep Vein Thrombosis (blood clot)
- Active infection in the legs
- Open wounds, rashes, or infection at the electrode sites
- Cancer or recently radiated tissue
- Cardiac pacemakers or neurostimulators
- Hypersensitivity to or inability to tolerate electrical stimulation
- Lower motor neuron injury or peripheral nerve injury in the legs that would prevent the muscles from responding to electrical stimulation
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stimulation-assisted Arm and Leg Cycling for Accelerated Recovery From Spinal Cord Injury
The purpose of this study is to examine interventions with paradigms involving upper and lower extremity cycling (A\&L cycling) with A\&L cycling with functional electrical stimulation (FES) (A\&L_FES group), A\&L cycling with FES and transcutaneous Spinal Cord Stimulation (A\&L_tSCS group), and control Body Weight Supported Treadmill Training (BWSTT) to potentially restore functional abilities (i.e., walking) in individuals with an incomplete spinal cord injury. The researchers hypothesize there will be improved walking function following these interventional groups.
Read the detailed description
Spinal cord injury (SCI) occurs at an annual rate of 50-60 per million in North America. Paralysis is also accompanied by drastic changes in independence and quality of life. SCI occurs mostly among younger individuals, half in people 16-30 years of age. Two-thirds of all SCIs are incomplete (iSCI), with some preserved neural connections relaying information to and from the brain. People with iSCI benefit most from improvements in walking. In addition to increasing independence, walking helps persons with iSCI remain active, with a variety of beneficial health-related outcomes. Therapy that can significantly increase sensorimotor function to these individuals living with iSCI for multiple decades would be hugely significant.
Currently, the most common strategies for restoring walking after an iSCI are manually intensive, including over ground walking with weight and balance support provided by multiple therapists, or with the use of expensive robotic support with controversial outcomes. Thus, the overarching goal of this proposal is to investigate if a non-specific gait rehabilitation paradigm based on motor-assisted arms and legs cycling, motor-assisted arms and legs cycling with functional electrical stimulation (FES) to the main muscles of the legs (A\&L_FES group), or motor-assisted arms and legs cycling with FES to the main muscles of the legs and transcutaneous spinal cord stimulation (tSCS) at the cervical level (A\&L_tSCS group) in AIS C and D iSCI individuals generalizes to improvements in walking that outperform conventional gait specific training, e.g., body-weight supported treadmill training (BWSTT; control group) (clinical assessments). The researchers will also investigate biomechanical and motor coordination changes and adaptations tied to these functional improvements (biomechanical assessments), and the neural mechanisms that explain functional improvements and their retention over time (neurophysiological assessments).
In the clinical assessments the researchers will investigate the clinically-relevant gait improvements afforded by the cycling intervention by measuring the walking gains with a battery of standard clinical tests focused on motor function, sensation, balance and spasticity. In the biomechanical assessments the researchers will focus on studying the detailed biomechanical basis for the gait improvements by using motion tracking, force plates, and EMG measurement to monitor the kinematics and kinetics of gait, and neuromuscular coordination. In the neurophysiological assessments the researchers will investigate the neuroplastic mechanisms underlying the gait improvements by conducting a battery of physiological tests to detect changes in the strength of descending and ascending spinal pathways.
- Conditions
- Spinal Cord Injury
- Being tested
- A&L cycling, Body weight supported treadmill training (BWSTT)
- Keywords
- Spinal cord injury, Rehabilitation, Cycling, Functional electrical stimulation, transcutaneous spinal cord stimulation, Neuroplasticity
- 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.
A&L cyclingDevice
Participants will complete simultaneous arms and legs cycling for 60min of active cycling. Targeted exercise intensity is 70-85% of the age-predicted maximum heart rate. Cycling resistance will be modified for continuous challenge. A target speed 10% above the highest speed at which each study participant is able to cycle voluntarily without motor, FES, or tSCS assistance will be selected during the first session and maintained throughout all training sessions. Once a participant can complete 60 minutes of continuous cycling at a specific resistance for two consecutive training sessions, the resistance will be increased to the next setting level at the mid-point of the subsequent session. Upon completion of each session, the physical therapists/researcher will complete skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks.
Body weight supported treadmill training (BWSTT)Device
The physical therapists/researchers will assist the patient with donning any necessary lower extremity braces and a padded walking harness. The patient will be assisted onto the treadmill via a ramp while seated in a wheelchair or by ambulation with physical assistance, clipped into the body weight support system, assisted to stand, and provided the appropriate amount of body weight support to allow for successful stepping for 60 minutes of active walking. During BWSTT, physical therapists/trainers will adjust treadmill speed or incline and the degree of body weight support to challenge participants. Participants will be instructed to exercise with a targeted intensity of 70-85% of the age-predicted maximum heart rate. Upon completion of each session, the harness will be doffed with skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A&L_tSCS group | Experimental | This paradigm combines A\&L_FES with transcutaneous spinal cord stimulation (tSCS)applied with cathodic electrodes at the C3-C4 and C6-C7 spinous processes and anodic electrodes at the iliac crests. The stimulation intensity is set to trigger a spinal evoked potential, ensuring a strong but tolerable sensation at the cathode sites without evoking direct motor responses in the arm or leg EMG. Receives: Device: A&L cycling |
| A&L_FES group | Sham comparator | This paradigm uses a commercially available motorized ergometer that link the arms \& legs mechanically to support voluntary arm and leg cycling and provide reciprocal movements that resemble those during walking. FES is used to assist the the voluntary leg movements, which also enhances proprioceptive feedback. Specifically, functional electrical stimulation (FES) is applied to the major muscles of both legs-including the quadriceps, hamstrings, and gluteus maximus-using pairs of surface electrodes. For sham transcutaneous spinal cord stimulation (tSCS), electrodes will be placed but no tSCS current will be delivered. Receives: Device: A&L cycling |
| BWSTT group | Active comparator | This is the control intervention. Participants will first be assisted by physical therapists/trainers to wear any necessary lower extremity braces along with a padded walking harness. They will then be helped onto the treadmill, either from a wheelchair via a ramp or by walking with physical assistance. Once on the treadmill, they will be clipped into the body weight support system, assisted to a standing position, and provided with the appropriate level of body weight support to facilitate successful stepping. Receives: Device: Body weight supported treadmill training (BWSTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-meter walking test (10MWT)
The 10-meter walking test (10MWT) is a physical function test measuring the total time to ambulate 10 meters in order to calculate walking speed in meters per second. A shorter time indicates a better walking speed.
Measured: Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Secondary outcomes (13)
Change in 6-minute walking test (6MWT)
The 6-minute walking test (6MWT) is a physical function test measuring the total distance walked in a span of six minutes will be assessed. A longer distance indicates a better walking distance.
Measured: Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in balance with the Berg balance scale (BBS)
Change in static and dynamic sitting and standing balance will be assessed using the Berg balance scale (BBS). Items are scored from zero to four. A higher score indicates better balance and decreased fall risk.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in walking ability with the WISCI
The Walking Index for Spinal Cord Injury (WISCI) assesses the ability of a person to walk after spinal cord injury. It consists of a rank ordering at the impairment level from most severe (0) to least severe (20) based on the amount of physical assistance required and use of assistive devices and/or braces while walking a 10-meter distance. A higher score indicates better walking ability.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a physical function test measuring spasticity on a 6-point ordinal scale. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. A lower score is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in step length
Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot. Typically a longer step length is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in step time
Step time is the amount of time that passes between the point of initial contact of one foot and the initial contact of the opposite foot. Typically a shorter step time is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in double support time
Double support time is the amount of time that passes during which both feet are simultaneously in contact with the ground in a gait cycle. Typically a shorter double support time is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in range of motion (ROM)
Joint angle and angular velocity will be computed with the anatomical neutral position as frame of reference in the sagittal plane and flexion and extension resulting in positive and negative joint angles, respectively. Range of motion will be calculated as the difference between the maximum and minimum hip, knee, and ankle joint angles. A larger range of motion is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in joint-joint cyclogram area
The area inside joint-joint cyclograms (e.g., hip-knee) will be calculated. A larger cyclogram area is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in the number of muscle synergies
Activation patterns and bipolar EMG signals of the leg muscles (gluteus medius, gluteus maximus, rectus femoris, adductor longus, medial hamstrings, tibialis anterior, and gastrocnemius medialis) and arm muscles (delta anterior, delta posterior, biceps brachii, triceps brachii) will be assessed bilaterally during walking. Muscle synergies will be identified from the EMG signals. A higher number of synergies is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in interlimb (upper-lower limb) modulation
This will be assessed by measuring changes in the magnitude and pattern of H-reflex suppression in the soleus (ankle extensor) of the leg during arm cycling. Features closer to that of a healthy individual is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in the strength of cortico-spinal connectivity
This will be measured using TMS of the motor cortex known to produce a motor evoked potential (MEP) in the main muscles of the leg, and peak-to-peak amplitude of the MEP and recruitment curves of MEP amplitude as a function of TMS strength will be calculated and constructed. Recruitment curves closer to that of a healthy individual is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in strength of periphery and somatosensory cortex
This will be measured using cutaneous electrodes on the arm and leg skin surface and recording the somatosensory evoked potentials (SSEPs) over the primary somatosensory cortex using electroencephalography (EEG) electrodes; peak-to-peak amplitude of the SEP and recruitment curves of SEP amplitude as a function of stimulus strength will be calculated and constructed. Recruitment curves closer to that of a healthy individual is a better outcome.
Measured: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study startDec 2025 (estimated)
- Primary completionMar 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose L Pons, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873776
- Sponsor's protocol ID
- STU00223113
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation-assisted Arm and Leg Cycling for Accelerated Recovery From Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06873776
- Acronym / sponsor ID
- STU00223113
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, Rehabilitation, Cycling, Functional electrical stimulation, transcutaneous spinal cord stimulation, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- Dec 2025 (estimated)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 13 Mar 2025 (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 purpose of this study is to examine interventions with paradigms involving upper and lower extremity cycling (A\&L cycling) with A\&L cycling with functional electrical stimulation (FES) (A\&L_FES group), A\&L cycling with FES and transcutaneous Spinal Cord Stimulation (A\&L_tSCS group), and control Body Weight Supported Treadmill Training (BWSTT) to potentially restore functional abilities (i.e., walking) in individuals with an incomplete spinal cord injury. The researchers hypothesize there will be improved walking function following these interventional groups.
Detailed description
Spinal cord injury (SCI) occurs at an annual rate of 50-60 per million in North America. Paralysis is also accompanied by drastic changes in independence and quality of life. SCI occurs mostly among younger individuals, half in people 16-30 years of age. Two-thirds of all SCIs are incomplete (iSCI), with some preserved neural connections relaying information to and from the brain. People with iSCI benefit most from improvements in walking. In addition to increasing independence, walking helps persons with iSCI remain active, with a variety of beneficial health-related outcomes. Therapy that can significantly increase sensorimotor function to these individuals living with iSCI for multiple decades would be hugely significant.
Currently, the most common strategies for restoring walking after an iSCI are manually intensive, including over ground walking with weight and balance support provided by multiple therapists, or with the use of expensive robotic support with controversial outcomes. Thus, the overarching goal of this proposal is to investigate if a non-specific gait rehabilitation paradigm based on motor-assisted arms and legs cycling, motor-assisted arms and legs cycling with functional electrical stimulation (FES) to the main muscles of the legs (A\&L_FES group), or motor-assisted arms and legs cycling with FES to the main muscles of the legs and transcutaneous spinal cord stimulation (tSCS) at the cervical level (A\&L_tSCS group) in AIS C and D iSCI individuals generalizes to improvements in walking that outperform conventional gait specific training, e.g., body-weight supported treadmill training (BWSTT; control group) (clinical assessments). The researchers will also investigate biomechanical and motor coordination changes and adaptations tied to these functional improvements (biomechanical assessments), and the neural mechanisms that explain functional improvements and their retention over time (neurophysiological assessments).
In the clinical assessments the researchers will investigate the clinically-relevant gait improvements afforded by the cycling intervention by measuring the walking gains with a battery of standard clinical tests focused on motor function, sensation, balance and spasticity. In the biomechanical assessments the researchers will focus on studying the detailed biomechanical basis for the gait improvements by using motion tracking, force plates, and EMG measurement to monitor the kinematics and kinetics of gait, and neuromuscular coordination. In the neurophysiological assessments the researchers will investigate the neuroplastic mechanisms underlying the gait improvements by conducting a battery of physiological tests to detect changes in the strength of descending and ascending spinal pathways.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A&L_tSCS group | Experimental | Device: A&L cyclingThis paradigm combines A\&L_FES with transcutaneous spinal cord stimulation (tSCS)applied with cathodic electrodes at the C3-C4 and C6-C7 spinous processes and anodic electrodes at the iliac crests. The stimulation intensity is set to trigger a spinal evoked potential, ensuring a strong but tolerable sensation at the cathode sites without evoking direct motor responses in the arm or leg EMG. |
| A&L_FES group | Sham comparator | Device: A&L cyclingThis paradigm uses a commercially available motorized ergometer that link the arms \& legs mechanically to support voluntary arm and leg cycling and provide reciprocal movements that resemble those during walking. FES is used to assist the the voluntary leg movements, which also enhances proprioceptive feedback. Specifically, functional electrical stimulation (FES) is applied to the major muscles of both legs-including the quadriceps, hamstrings, and gluteus maximus-using pairs of surface electrodes. For sham transcutaneous spinal cord stimulation (tSCS), electrodes will be placed but no tSCS current will be delivered. |
| BWSTT group | Active comparator | Device: Body weight supported treadmill training (BWSTT)This is the control intervention. Participants will first be assisted by physical therapists/trainers to wear any necessary lower extremity braces along with a padded walking harness. They will then be helped onto the treadmill, either from a wheelchair via a ramp or by walking with physical assistance. Once on the treadmill, they will be clipped into the body weight support system, assisted to a standing position, and provided with the appropriate level of body weight support to facilitate successful stepping. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Traumatic or non-traumatic SCI T11 and above (upper motorneuron lesion)
- Incomplete paraplegia or tetraplegia (Classified as AIS C or D)
- Age range 18-75 years old, inclusive
- At least 1 year post- injury
- Independent ambulator (with normal assistive devices or bracing) for at least 10 meters (30 feet)
Key exclusion criteria (25 listed)
- SCI T12 and below (or lacking upper motorneuron injury)
- Complete paraplegia or tetraplegia (classified as AIS A)
- AIS B incomplete paraplegia or tetraplegia
- Presence of progressive neurologic disease
- Unable to give informed consent to participate in the study
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 |
|---|---|---|
| A&L cyclingParticipants will complete simultaneous arms and legs cycling for 60min of active cycling. Targeted exercise intensity is 70-85% of the age-predicted maximum heart rate. Cycling resistance will be modified for continuous challenge. A target speed 10% above the highest speed at which each study participant is able to cycle voluntarily without motor, FES, or tSCS assistance will be selected during the first session and maintained throughout all training sessions. Once a participant can complete 60 minutes of continuous cycling at a specific resistance for two consecutive training sessions, the resistance will be increased to the next setting level at the mid-point of the subsequent session. Upon completion of each session, the physical therapists/researcher will complete skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks. | Device | A&L_FES group, A&L_tSCS group |
| Body weight supported treadmill training (BWSTT)The physical therapists/researchers will assist the patient with donning any necessary lower extremity braces and a padded walking harness. The patient will be assisted onto the treadmill via a ramp while seated in a wheelchair or by ambulation with physical assistance, clipped into the body weight support system, assisted to stand, and provided the appropriate amount of body weight support to allow for successful stepping for 60 minutes of active walking. During BWSTT, physical therapists/trainers will adjust treadmill speed or incline and the degree of body weight support to challenge participants. Participants will be instructed to exercise with a targeted intensity of 70-85% of the age-predicted maximum heart rate. Upon completion of each session, the harness will be doffed with skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks. | Device | BWSTT group |
Primary outcome
Change in 10-meter walking test (10MWT)
Time frame: Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
The 10-meter walking test (10MWT) is a physical function test measuring the total time to ambulate 10 meters in order to calculate walking speed in meters per second. A shorter time indicates a better walking speed.
13 secondary outcomes
Change in 6-minute walking test (6MWT)
Time frame: Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in balance with the Berg balance scale (BBS)
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in walking ability with the WISCI
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in Modified Ashworth Scale (MAS)
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in step length
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in step time
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in double support time
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in range of motion (ROM)
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in joint-joint cyclogram area
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Change in the number of muscle synergies
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in interlimb (upper-lower limb) modulation
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in the strength of cortico-spinal connectivity
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Changes in strength of periphery and somatosensory cortex
Time frame: Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- 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.
Jose L Pons, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A&L cycling and Body weight supported treadmill training (BWSTT) in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
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 9 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 23 May 2025. 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 States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in 10-meter walking test (10MWT) (time frame: Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.). 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 23 May 2025.