Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury (PROPEL-SCI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Procedure: Body Weight Supported Treadmill Training

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Barry, MS, CCRC; Phone Number: 3122381435; Email: abarry@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • The Shirley Ryan AbilityLab
      • Contact: Alexander Barry, MS, CCRC; Phone Number: 312-238-1435; Email: abarry@sralab.org
      • Contact: Milap Sandhu, Phd; Phone Number: 312-238-6529; Email: msandhu@sralab.org
      • Principal Investigator: Milap Sandhu, PhD
      • Sub-Investigator: William Z Rymer, MD, PhD
  • Texas
    • Fort Worth, Texas, United States, 76132
      • Not yet recruiting
      • Baylor Scott and White Institute for Rehabilitation
      • Contact: Faith Meza, MPH; Phone Number: 214-820-9409; Email: faith.meza@bswhealth.org
      • Principal Investigator: Chad Swank, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early Intervention; Additional training will begin no more than 60 days following spinal cord injury	Procedure: 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.; Other Names: BWSTT
Active Comparator: Sub-acute Intervention; Additional training will occur 3 months following spinal cord injury	Procedure: 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.; Other Names: BWSTT
Active Comparator: Chronic Intervention; Additional training will occur 6-12 months following SCI	Procedure: 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.; Other Names: BWSTT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 Meter walk test	Used to assess walking speed, time taken to walk 10 meters at fastest pace	1-5 days Following Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk test	Used to assess distance traveled during a 6 minute walking test at a self selected pace	1-5 days Following Intervention
Walking Index for spinal cord injury	Assessment to determine the physical assistance and assistive devices needed to walk 10 meters	1-5 days following intervention
Daily step counts	Step counts from a waist worn activity tracker	2 weeks following 3-, 6-, 9-, and 12- month assessments
Gait Deviation idex	A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system	Baseline, 3-, 6-, 9-, and 12- month assessments

Collaborators and Investigators

• Sponsor: Milap Sandhu
• Collaborators: University of Florida; Baylor Scott and White Health
• Investigators: Principal Investigator: Milap Sandhu, PhD, Shirley Ryan Abilitylab

Publications and helpful links

General Publications

• Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: STU00219541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not currently planning to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No