Arm and Leg Cycling for Accelerated SCI Recovery

Not Applicable

• Conditions: Spinal Cord Injury

• Registration Number: NCT06873776
• Lead Sponsor: Shirley Ryan AbilityLab

Brief 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 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 Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Study Start: 2025-12
• Primary Completion: 2032-03
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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)
• 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

Exclusion Criteria

• 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in 10-meter walking test (10MWT)	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.

Secondary Outcome Measures

Name	Time	Method
Change in balance with the Berg balance scale (BBS)	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in step length	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in 6-minute walking test (6MWT)	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 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.
Change in walking ability with the WISCI	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in Modified Ashworth Scale (MAS)	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in step time	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in double support time	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in the number of muscle synergies	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Changes in interlimb (upper-lower limb) modulation	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Changes in the strength of cortico-spinal connectivity	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Changes in strength of periphery and somatosensory cortex	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in range of motion (ROM)	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	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.
Change in joint-joint cyclogram area	Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.	The area inside joint-joint cyclograms (e.g., hip-knee) will be calculated. A larger cyclogram area is a better outcome.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States