Exoskeleton-Assisted Walking ExoAtlet II

NCT04532723 | Withdrawn

• 1 other identifier: IRBNet ID 1559813
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• Change in Skin Integrity

  Skin breakdown

  change from baseline skin integrity at 2 weeks

• Change in Falls

  Number of falls

  change from baseline number of falls at 2 weeks

• Change in Fractures

  Number of fractures and cause

  change from baseline number of fractures at 2 weeks

Secondary Outcomes (11)

• Heart Rate

  Baseline, Week 1

• Blood pressure

  Baseline, Week 1

• Spasticity

  Baseline, Week 1, Week 2

• Standing Time

  Baseline, Week 1

• Ambulation Time

  Week 1

Study Arms (1)

ExoAtlet II

EXPERIMENTAL

Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI

Device: ExoAtlet II

Interventions

ExoAtlet II DEVICE

ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured

ExoAtlet II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D)
• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Craig Hospital: lead
• COSMO ROBOTICS CO., Ltd: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation; PT,DPT,PhD,NCS

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: August 31, 2020
• Study Start: June 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 26, 2021

Record last verified: 2021-08