Arm and Leg Cycling for Accelerated Recovery From SCI

NCT05619146 | Active Not Recruiting FDA Device

• 1 other identifier: STU00216731
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Rehabilitation; Cycling

Outcome Measures

Primary Outcomes (2)

• 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.

• Change in 6-minute walking test (6MWT)

  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.

  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 (14)

• Change in motor and sensory scores (ASIA)

  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 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 walking ability with the WISCI

  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 Modified Ashworth Scale (MAS)

  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 muscle testing or strength

  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.

Study Arms (1)

SCI subject

EXPERIMENTAL

Subject with SCI

Device: Motor-assisted arms and legs cycling

Interventions

Motor-assisted arms and legs cycling DEVICE

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.

SCI subject

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

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 AbilityL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 16, 2022
• Study Start: January 23, 2023
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)