Clinical trial NCT05619146: Arm and Leg Cycling for Accelerated Recovery From SCI
Official title: Upper and Lower Extremity Cycling in Incomplete Spinal Cord Injury Individuals to Promote Limb Recovery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Rehabilitation
Cycling
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will complete 60min of active cycling training paradigm, 5 times a week, for 12 weeks. The cycling ergometer will be used to provide motorized assistance during simultaneous arms and legs cycling to the participant while they are seated.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the ability of simultaneous motorized upper and lower extremity cycling training to regulate spinal movement patterns in order 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 motorized cycling.

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 in AIS C and D iSCI individuals generalizes to improvements in walking that outperform conventional gait specific training (Specific Aim 1). The researchers will also investigate biomechanical and motor coordination changes and adaptations tied to these functional improvements (Specific Aim 2), and the neural mechanisms that explain functional improvements and their retention over time (Specific Aim 3).

Specifically, in Specific Aim 1 the researchers will investigate the clinically-relevant gait improvements afforded by the cycling intervention. In Specific Aim 2 the researchers will focus on studying the detailed biomechanical basis for the gait improvements. In Specific Aim 3 the researchers will investigate the neuroplastic mechanisms underlying the gait improvements. For these Aims, the researchers will measure the walking gains with a battery of standard clinical tests focused on motor function, sensation, balance and spasticity (Specific Aim 1). The researchers will use motion tracking, force plates, and EMG measurement to monitor the kinematics and kinetics of gait, the neuromuscular coordination, and oxygen consumption as a measure of these energetics of walking (Specific Aim 2). In addition, the researchers will conduct a battery of physiological tests at 3-week intervals intended to detect changes in the strength of descending and ascending spinal pathways (Specific Aim 3).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Traumatic 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 fully engaging in study procedures
* MRI contraindications:
* Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
* Metal in the body (rods, plates, screws, shrapnel, dentures, metal IUD, etc)
* Surgical clips in the head or previous neurosurgery
* Cochlear implants
* Prosthetic heart valves
* Claustrophobia
* Tremor
* TMS contraindications
* Epilepsy or any other type of seizure history
* Medications that increase the risk of seizures
* Non-prescribed drug or marijuana use
* Depression, antidepressant medications, or antipsychotic medications
* Pregnancy
* Prisoners

Primary outcomes:
measure: Change in 10-meter walking test (10MWT)
timeFrame: 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.
measure: Change in 6-minute walking test (6MWT)
timeFrame: 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:
measure: Change in motor and sensory scores (ASIA)
timeFrame: 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.
measure: Change in balance with the Berg balance scale (BBS)
timeFrame: 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.
measure: Change in walking ability with the WISCI
timeFrame: 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.
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: 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.
measure: Change in muscle testing or strength
timeFrame: 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.
measure: Changes in EMG activation patterns
timeFrame: 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.
measure: Changes in interlimb (upper-lower limb) modulation
timeFrame: 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.
measure: Changes in the strength of cortico-spinal connectivity
timeFrame: 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.
measure: Changes in strength of periphery and somatosensory cortex
timeFrame: 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.
measure: Change in stride variability.
timeFrame: 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.
measure: Change in cadence.
timeFrame: 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.
measure: Change in step length.
timeFrame: 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.
measure: Change in stride length.
timeFrame: 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.
measure: Change in stance time.
timeFrame: 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.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityL
name: Jose L Pons, PhD
role: PRINCIPAL_INVESTIGATOR
References: