Recruiting

Observational Study

Sponsor:

Milap Sandhu

Code:

NCT06176833

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Body Weight Supported Treadmill Training

Study Details

Brief summary:

The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.

The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.

Conditions

Spinal Cord Injuries

Study ID

NCT06176833

Start date

Mar 21, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
  • Between the ages of 16-74
  • Weight bearing as tolerated in bilateral lower extremities
  • Able to tolerate a harness
  • Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
  • Able to provide informed consent within 60 days of injury onset
  • Able to participate in all study related activities, including 1-year follow up

Exclusion Criteria:

  • Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
  • A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
  • Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
  • Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
  • Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
  • Pregnancy, as confirmed by blood draw

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early Intervention

Additional training will begin no more than 60 days following spinal cord injury

active comparator: Sub-acute Intervention

Additional training will occur 3 months following spinal cord injury

active comparator: Chronic Intervention

Additional training will occur 6-12 months following SCI

no intervention: Standard of Care

This group only receives standard of care treatment but is assessed at the same time points as the other groups

Interventions

Body Weight Supported Treadmill Training

For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.

Primary outcome measure

  • 10 Meter walk test [ Time Frame: 1-5 days Following Intervention ]

Central Contacts and Locations

Central contacts

Alexander Barry, MS, CCRC

3122381435abarry@sralab.org

Locations

The Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Alexander Barry, MS, CCRC

312-238-1435abarry@sralab.org

Principal Investigator:

Milap Sandhu, PhD

More Information

Sponsor

Milap Sandhu

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milap Sandhu on 2026-07-06.