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

NCT06176833 | Recruiting DMC

• 1 other identifier: STU00219541
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 10 Meter walk test

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

  1-5 days Following Intervention

Secondary Outcomes (4)

• 6 Minute Walk test

  1-5 days Following Intervention

• Walking Index for spinal cord injury

  1-5 days following intervention

• Daily step counts

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

• Gait Deviation idex

  Baseline, 3-, 6-, 9-, and 12- month assessments

Study Arms (4)

Early Intervention

ACTIVE COMPARATOR

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

Procedure: Body Weight Supported Treadmill Training

Sub-acute Intervention

ACTIVE COMPARATOR

Additional training will occur 3 months following spinal cord injury

Procedure: Body Weight Supported Treadmill Training

Chronic Intervention

ACTIVE COMPARATOR

Additional training will occur 6-12 months following SCI

Procedure: Body Weight Supported Treadmill Training

Standard of Care

NO INTERVENTION

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 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.

Also known as: BWSTT

Chronic Intervention; Early Intervention; Sub-acute Intervention

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milap Sandhu: lead
• Baylor Scott and White Health: collaborator
• University of Florida: collaborator

Study Sites (2)

The Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Baylor Scott and White Institute for Rehabilitation

Fort Worth, Texas, 76132, United States

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39702102 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Milap Sandhu, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Barry, MS, CCRC

CONTACT

3122381435; abarry@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessor will have no knowledge of groups, cannot blind participants as they know when they will be receiving the additional training
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)