Arm and Leg Cycling for Accelerated SCI Recovery

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

Interventions

DEVICE

A&L cycling

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.

DEVICE

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.

Sponsors & Collaborators

• University of Alberta

  collaborator OTHER

• Shirley Ryan AbilityLab

  lead OTHER

Principal Investigators

• Jose L Pons, PhD · Shirley Ryan AbilityLab

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2032-03-31

Completion

2032-09-30

Countries

• United States

Study Locations