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Early Intervention for Spinal Cord Injury (PROPEL-SCI Trial)

N/A

Recruiting

Led By Milap Sandhu, PhD

Research Sponsored by Milap Sandhu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight bearing as tolerated in bilateral lower extremities

History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PROPEL-SCI Trial Summary

This trial is investigating whether a specific type of walking therapy, called body weight supported treadmill training (BWSTT), can improve walking ability in individuals with spinal cord injuries. The study will examine if starting

Who is the study for?

This trial is for individuals who have experienced a traumatic spinal cord injury. It's designed to see if starting walking therapy at different times within the first 6 months post-injury affects recovery. Participants must be in the early stages of their rehabilitation and will be randomly assigned to one of four groups, with three receiving additional therapy.Check my eligibility

What is being tested?

The study tests body weight supported treadmill training (BWSTT), which helps people walk on a treadmill with the aid of a harness that supports some of their body weight. The goal is to determine if the timing of when this therapy starts after an injury influences its effectiveness.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include muscle soreness, fatigue, skin irritation from the harness, or discomfort during exercise. These are common reactions to physical therapy exercises.

PROPEL-SCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can put weight on both of my legs as much as I can tolerate.

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I have a spinal cord injury between my neck and mid-back that still allows for some movement or sensation.

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I can wear a harness comfortably.

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I am between 16 and 74 years old.

PROPEL-SCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks following 3-, 6-, 9-, and 12- month assessments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10 Meter walk test

Secondary outcome measures

6 Minute Walk test

Daily step counts

Gait Deviation idex

+1 more

PROPEL-SCI Trial Design

4Treatment groups

Active Control

Group I: Early InterventionActive Control1 Intervention

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

Group II: Sub-acute InterventionActive Control1 Intervention

Additional training will occur 3 months following spinal cord injury

Group III: Chronic InterventionActive Control1 Intervention

Additional training will occur 6-12 months following SCI

Group IV: Standard of CareActive Control1 Intervention

This group only receives standard of care treatment but is assessed at the same time points as the other groups

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milap SandhuLead Sponsor

Baylor Scott and White HealthOTHER

15 Previous Clinical Trials

156,148 Total Patients Enrolled

University of FloridaOTHER

1,341 Previous Clinical Trials

715,538 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participating in this medical study inclusive of individuals aged 60 years and above?

"Individuals aged 16 years or older but younger than 75 years are eligible for enrollment in this study."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"As per the information provided by clinicaltrials.gov, this particular clinical trial is not currently in the process of actively recruiting patients. The initial posting of the study occurred on January 1st, 2024, and it was most recently updated on December 11th, 2023. It's worth noting that there are presently numerous other clinical trials seeking participants—specifically, a total of 954 ongoing trials at present."

Answered by AI

Do I meet the necessary requirements to participate in this clinical study?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of spinal cord injury and fall within the age range of 16 to 75 years old. Approximately 108 participants are being sought for recruitment into this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Milap Sandhu 2024. "Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176833.