Exoskeleton-Assisted Walking ExoAtlet II

• ClinicalTrials.gov Identifier: NCT04532723
• Recruitment Status: Withdrawn
• First Posted: August 31, 2020
• Last Update Posted: August 26, 2021
• Sponsor: Craig Hospital
• Collaborator: ExoAtlet
• Information provided by (Responsible Party): Candace Tefertiller, Craig Hospital

Study Description

Brief Summary:

Based on prior exoskeleton research, it was determined that 40 participants of variable height, weight and injury level would provide a significant measure of the safety and feasibility of using the ExoAtlet II in individuals with SCI for standing and walking rehabilitation therapy. Craig Hospital will be responsible for enrolling up to 30 individuals during the study duration.The inclusion criteria will be utilized to identify appropriate subjects for this study.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Device: ExoAtlet II	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exoskeleton-Assisted Walking ExoAtlet II
• Estimated Study Start Date: June 2021
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: October 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: ExoAtlet II; Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI	Device: ExoAtlet II; ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured

Outcome Measures

Primary Outcome Measures :

1. Change in Skin Integrity [ Time Frame: change from baseline skin integrity at 2 weeks ]
   Skin breakdown
2. Change in Falls [ Time Frame: change from baseline number of falls at 2 weeks ]
   Number of falls
3. Change in Fractures [ Time Frame: change from baseline number of fractures at 2 weeks ]
   Number of fractures and cause

Secondary Outcome Measures :

1. Heart Rate [ Time Frame: Baseline, Week 1 ]
   Heart rate beats per minute
2. Blood pressure [ Time Frame: Baseline, Week 1 ]
   Blood pressures mm/Hg
3. Spasticity [ Time Frame: Baseline, Week 1, Week 2 ]
   Modified Ashworth
4. Standing Time [ Time Frame: Baseline, Week 1 ]
   Upright and weight bearing total time
5. Ambulation Time [ Time Frame: Week 1 ]
   Total walking time
6. Standing Assistance [ Time Frame: Baseline, Week 1 ]
   level of assistance in standing
7. Ambulation Assistance [ Time Frame: Week 1 ]
   Level of assistance for walking
8. 6 Minute Walk Test [ Time Frame: Week 1 ]
   Total distance walked in 6 minutes
9. 10 Meter Walk Test [ Time Frame: Week 1 ]
   total time to walk 10 meters
10. Physical Activity Enjoyment Scale [ Time Frame: Baseline, Week 1, Week 2 ]
    Scale of participant enjoyment in the moment. 7-point bipolar rating scale, eleven items are reverse scored. Higher total score reflect greater levels of enjoyment
11. BORG Rate of Perceived Exertion [ Time Frame: Baseline, Week 1 ]
    Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D)
• 18 Years of age or older in general good health
• Weight, no more than 220lbs (100kg)
• Intact Skin
• Able to stand without exhibiting symptomatic hypotension
• Use a wheelchair for mobility at least 50% of the day
• Enough strength in hands and shoulders to support standing and walking using crutches or a walker

• Medical clearance for full weight-bearing

  ---Per our clinical guidelines, we will require all individuals with SCI who are going to use an exoskeleton to receive full weight-bearing medical clearance from their physician prior to participation. If they are unable to obtain full weight-bearing medical clearance they will not be able to participate in this study.

• Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
• Hip width no greater than 18" (46 cm) measured when sitting
• Femur length between 37 cm and 49 cm measured between mid-patellar tendon and the floor

Exclusion Criteria:

• Spinal cord injury level higher than T4 (AIS A-C) or C7 ASIA D
• Severe muscle stiffness/tightness
• Significant spasticity (Modified Ashworth Scale score of 3 or above)
• Trunk or lower extremity pressure wound
• Unstable spine, un-healed limbs, or fractures

• Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints

  ---Each individual who is interested in participating in this study will be screened for heterotropic ossification (HO) using a verbal checklist first and then they participate in a thorough range of motion (ROM) evaluation before being fit in the exoskeleton. If they verbalize a history of HO or demonstrate a bony block/resistance to passive ROM, they will be sent back to their physician to rule out HO and will not participate in the study until they receive additional clearance.

• Joint instability, dislocation, moderate to severe hip dysplasia
• Uncontrolled seizures
• Fracture or lower-limb surgery in past year
• Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton
• Pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Candace Tefertiller, Executive Director of Research and Evaluation; PT,DPT,PhD,NCS, Craig Hospital
• ClinicalTrials.gov Identifier: NCT04532723
• Other Study ID Numbers: IRBNet ID 1559813
• First Posted: August 31, 2020
• Last Update Posted: August 26, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries