Arm and Leg Cycling for Accelerated SCI Recovery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06873776
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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 Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
May 2025
Primary completion
Mar 31, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: A&L_tSCS group
    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.
  • Sham Comparator: A&L_FES group
    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.
  • Active Comparator: BWSTT group
    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.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611-

Find similar trials in Chicago, IL

By research site
Shirley Ryan AbilityLab· Chicago, IL

Related Studies