RECRUITING

Exoskeleton and Spinal Cord Stimulation for SCI

Conditions

Spinal Cord Injury Ambulation Difficulty Muscle Spasticity Spinal Cord injury (SCI)Transcutaneous lumbosacral stimulation (TLS)Exoskeleton-Assisted Walking (EAW)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exoskeleton and Spinal Cord Stimulation for SCI

Quick Facts

Study Start:2017-03-30

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03096197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 58 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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 21-58 years old; * have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10; * be wheelchair reliant 100% of the time; * have knee bone mineral density great than .5755gm/cm2 as determined by study staff; * have a height between 62 inches to 74 inches.	* have a history of broken or fractured bones. * have a history of bone trauma or bone disease.

Inclusion Criteria

Exclusion Criteria

* 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 21-58 years old;
* have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10;
* be wheelchair reliant 100% of the time;
* have knee bone mineral density great than .5755gm/cm2 as determined by study staff;
* have a height between 62 inches to 74 inches.

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

Contacts and Locations

Study Contact

Gail F Forrest, PhD

CONTACT

973-324-3518

gforrest@kesslerfoundation.org

Principal Investigator

Gail F. Forrest, PhD

PRINCIPAL_INVESTIGATOR

Kessler Foundation

Study Locations (Sites)

Kessler Foundation

West Orange, New Jersey, 07052

United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Gail F. Forrest, PhD, PRINCIPAL_INVESTIGATOR, Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-30

Study Completion Date2025-09

Study Record Updates

Study Start Date2017-03-30

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Spinal Cord injury (SCI)
Transcutaneous lumbosacral stimulation (TLS)
Exoskeleton-Assisted Walking (EAW)

Additional Relevant MeSH Terms

Spinal Cord Injury
Ambulation Difficulty
Muscle Spasticity