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NCT Number: NCT06176833

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Shirley Ryan AbilityLab, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Weight Supported Treadmill Training

Procedure

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.

Other names: BWSTT

Primary outcomes

  1. 10 Meter walk test

    Time frame: 1-5 days Following Intervention

    Used to assess walking speed, time taken to walk 10 meters at fastest pace

Secondary outcomes

  1. 6 Minute Walk test

    Time frame: 1-5 days Following Intervention

    Used to assess distance traveled during a 6 minute walking test at a self selected pace

  2. Walking Index for spinal cord injury

    Time frame: 1-5 days following intervention

    Assessment to determine the physical assistance and assistive devices needed to walk 10 meters

  3. Daily step counts

    Time frame: 2 weeks following 3-, 6-, 9-, and 12- month assessments

    Step counts from a waist worn activity tracker

  4. Gait Deviation idex

    Time frame: Baseline, 3-, 6-, 9-, and 12- month assessments

    A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Barry, MS, CCRC

CONTACT

[email protected]

3122381435

Sponsors and collaborators

Lead sponsor

Milap Sandhu

Other

Collaborators

  • Baylor Scott and White Health
  • Congressionally Directed Medical Research Programs
  • University of Florida

Registry information

Official study title

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

Acronym: PROPEL-SCI

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Dec 20, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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