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

Spinal Cord Injuries Clinical Trial

— PROPEL-SCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176833
• Other study ID #: STU00219541
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Shirley Ryan AbilityLab
• Contact: Alexander Barry, MS, CCRC
• Phone: 3122381435
• Email: abarry[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The Shirley Ryan AbilityLab	Chicago	Illinois
United States	Baylor Scott and White Institute for Rehabilitation	Fort Worth	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Milap Sandhu	Baylor Scott and White Health, University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 Meter walk test	Used to assess walking speed, time taken to walk 10 meters at fastest pace	1-5 days Following Intervention
Secondary	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
Secondary	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
Secondary	Daily step counts	Step counts from a waist worn activity tracker	2 weeks following 3-, 6-, 9-, and 12- month assessments
Secondary	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