Combining exoskeleton-assisted walking with spinal stimulation for spinal cord injury recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of combining transcutaneous lumbosacral stimulation (TLS) with exoskeleton-assisted walking (EAW) in improving walking recovery for individuals with incomplete spinal cord injuries. A total of 24 participants will be randomly assigned to either an EAW+TLS group or an EAW alone group, with each group undergoing 80 sessions of robotic training over 28 weeks. The EAW+TLS group will receive stimulation during their walking sessions, while the control group will not. The study will assess the impact of this combined approach on ambulation difficulties and muscle spasticity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to be eligible to participate in this study a participant must:

* be a non-walker with an SCI greater than 6 years post injury;
* have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;
* be between the ages of 18-65 years old;
* have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10;
* be wheelchair reliant 100% of the time;
* have knee bone mineral density great than .5755gm/cm2 as determined by study staff;

Exclusion Criteria:

* have a history of broken or fractured bones.
* have a history of bone trauma or bone disease.

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Gail F. Forrest, PhD — Kessler Foundation
• Study coordinator: Gail F Forrest, PhD
• Email: gforrest@kesslerfoundation.org
• Phone: 973-324-3518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.