Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT02991248

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

robotic training

spinal cord electrical stimulation

treadmill

Study Details

Brief summary:

This study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. One group will receive pelvis perturbation training paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and one group will receive treadmill training only.

Conditions

Spinal Cord Injury

Study ID

NCT02991248

Start date

Nov 1, 2018

Status verified date

May, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Jul 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age between 18 and 65 years;
2. medically stable with medical clearance to participate;
3. level of the SCI lesion between C4-T10;
4. passive range of motion of the legs within functional limits of ambulation;
5. ability to walk on a treadmill for more than 20 minutes with partial body weight support as needed and short sitting/standing breaks;
6. ability to ambulate without orthotics or with orthotics that do not cross the knee for more than 10 meters

Exclusion Criteria:

1. the presence of unhealed decubiti, existing infection, severe cardiovascular and pulmonary disease, concomitant central or peripheral neurological injury (e.g. traumatic head injury or peripheral nerve damage in lower limbs);
2. history of recurrent fractures and/or known orthopedic injury to the lower extremities;
3. Botox injection within 6 months of starting the study, and current receiving physical therapy treatment;
4. have metallic implantation in the spinal region underneath where electrodes may be placed.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: robotic training & stimulation

Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.

active comparator: robotic training & sham

Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.

placebo comparator: treadmill only

Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.

Interventions

robotic training

robotic training by applying pelvis force perturbation

spinal cord electrical stimulation

Applying direct current electrical stimulation on spinal cord

treadmill

conventional treadmill training only

Primary outcome measure

  • Changes in overground gait speed from baseline [ Time Frame: post 6 weeks of training and 8 weeks after the end of training ]

Central Contacts and Locations

Central contacts

Locations

Abilitylab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jun 3, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-06-03.