Arm and Leg Cycling for Accelerated SCI Recovery

NCT06873776 | Enrolling By Invitation

• 1 other identifier: STU00223113
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; Rehabilitation; Cycling; Functional electrical stimulation; transcutaneous spinal cord stimulation; Neuroplasticity

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  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)

  Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.

• Change in step length

  Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.

Other Outcomes (2)

• Change in motor and sensory scores (ASIA)

  Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.

• Change in functional gait assessment (FGA)

  Changes across baseline, after 6 weeks of training, after 12 weeks of training, and 6 months after completing training.

Study Arms (3)

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.

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.

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.

Device: Body weight supported treadmill training (BWSTT)

Interventions

A&L cycling DEVICE

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.

A&L_FES group; A&L_tSCS group

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.

BWSTT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Cisgender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of Alberta: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)