ClinicalTrials.gov
ClinicalTrials.gov Menu

Exoskeleton and Spinal Cord Stimulation for SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03096197
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Gail Forrest, Kessler Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Ambulation Difficulty Muscle Spasticity Device: Exoskeleton-Assisted Walking Device: Transcutaneous Lumbosacral Stimulation (TLS) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exoskeleton and Spinal Cord Stimulation for SCI
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: EAW + TLS
The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).
Device: Exoskeleton-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.

Device: Transcutaneous 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.
Other Name: RT 50 Sage Stimulator

Experimental: EAW without TLS
EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .
Device: Exoskeleton-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.




Primary Outcome Measures :
  1. Percentage change 6-minute walk test (6MWT) [ Time Frame: Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. ]
    Participants undergoing EAW+TLS intervention will walk significantly further than those receiving EAW alone.

  2. Percentage change 10 meter walk test (10MWT) [ Time Frame: Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. ]
    Participants undergoing EAW+TLS intervention will walk significantly faster than those receiving EAW alone training.


Secondary Outcome Measures :
  1. Percentage change in scores on Berg Balance scale (BERG) [ Time Frame: Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. ]
    Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in standing balance than those receiving EAW alone training.

  2. Absolute change in the International Standards Examination [ Time Frame: Baseline and post intervention ]
    Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in lower extremity motor scores (LEMS) than those receiving EAW alone training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096197


Contacts
Contact: Gail F Forrest, PhD 973-324-3518 ext 3518 gforrest@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Gail F Forrest, Ph.D    973-324-3518    gforrest@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: Gail F. Forrest, PhD Kessler Foundation

Responsible Party: Gail Forrest, Assistant Director of HPER, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03096197     History of Changes
Other Study ID Numbers: 90RE5021-01-00
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Gail Forrest, Kessler Foundation:
Spinal Cord injury (SCI)
Transcutaneous lumbosacral stimulation (TLS)
Exoskeleton-Assisted Walking (EAW)

Additional relevant MeSH terms:
Spinal Cord Injuries
Muscle Spasticity
Mobility Limitation
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms