SCI subject for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryMotor-assisted arms and legs cycling - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: 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.

Month 6
Change in 10-meter walking test (10MWT)
Change in 6-minute walking test (6MWT)
Change in Modified Ashworth Scale (MAS)
Change in balance with the Berg balance scale (BBS)
Change in cadence.
Change in motor and sensory scores (ASIA)
Change in muscle testing or strength
Change in stance time.
Change in step length.
Change in stride length.
Change in stride variability.
Change in walking ability with the WISCI
Changes in EMG activation patterns
Changes in interlimb (upper-lower limb) modulation
Changes in strength of periphery and somatosensory cortex
Changes in the strength of cortico-spinal connectivity

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

SCI subject
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: SCI subject · No Placebo Group · N/A

SCI subject
Device
Experimental Group · 1 Intervention: Motor-assisted arms and legs cycling · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,697 Total Patients Enrolled
Jose L Pons, PhDPrincipal InvestigatorShirley Ryan AbilityL
3 Previous Clinical Trials
160 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a traumatic SCI at T10 or above (upper motor neuron lesion).
You have a complete or incomplete spinal cord injury (SCI).