RecruitingNot ApplicableNCT03096197

Exoskeleton and Spinal Cord Stimulation for SCI


Sponsor

Kessler Foundation

Enrollment

24 participants

Start Date

Mar 30, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria2

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

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Interventions

DEVICEExoskeleton-Assisted Walking

Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.

DEVICETranscutaneous Lumbosacral Stimulation (TLS)

EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.


Locations(1)

Kessler Foundation

West Orange, New Jersey, United States

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NCT03096197


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