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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (4)

• 6 Minute Walk test [Time frame: 1-5 days Following Intervention]
• Walking Index for spinal cord injury [Time frame: 1-5 days following intervention]
• Daily step counts [Time frame: 2 weeks following 3-, 6-, 9-, and 12- month assessments]
• Gait Deviation idex [Time frame: Baseline, 3-, 6-, 9-, and 12- month assessments]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• The Shirley Ryan AbilityLab — Chicago
• Baylor Scott and White Institute for Rehabilitation — Fort Worth

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. PMID 39702102

Identifiers

NCT: NCT06176833 · STU00219541 · CDMRP- SC220241

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗