RECRUITING

Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training

Quick Facts

Study Start:2024-03-21
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06176833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
  2. * Between the ages of 16-74
  3. * Weight bearing as tolerated in bilateral lower extremities
  4. * Able to tolerate a harness
  5. * Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
  6. * Able to provide informed consent within 60 days of injury onset
  7. * Able to participate in all study related activities, including 1-year follow up
  1. * Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
  2. * A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
  3. * Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
  4. * Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
  5. * 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
  6. * Pregnancy, as confirmed by blood draw

Contacts and Locations

Study Contact

Alexander Barry, MS, CCRC
CONTACT
3122381435
abarry@sralab.org

Principal Investigator

Milap Sandhu, PhD
PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab

Study Locations (Sites)

The Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States
Baylor Scott and White Institute for Rehabilitation
Fort Worth, Texas, 76132
United States

Collaborators and Investigators

Sponsor: Milap Sandhu

  • Milap Sandhu, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries