Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)

NCT04149769 | Withdrawn DMC FDA Device

• 1 other identifier: SC140121 Study 3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The proposed study is a pilot study intended to inform the hypothesis that regular walking in an exoskeleton within the home and community might offer health benefit, neurological recovery, and/or mobility benefit to the user. This exploratory pilot study is also intended to assess the level of compliance (i.e., exoskeleton use) among study participants by characterizing extent the device is used beyond the minimum required.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• Ten meter walk test (10MWT)

  Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

  18 weeks

• Six minute walk test (6MWT)

  Measure of gait speed over six minutes while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

  18 weeks

• Walking Index for Spinal Cord Injury II (WISCI-II)

  Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.

  18 weeks

• Functional Independence Measures (FIM) gait score

  Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 7 (0= activity does not occur and 7= complete independence

  18 weeks

Secondary Outcomes (9)

• Timed Up and Go Test (TUG)

  18 weeks

• Borg Rating Scale of Perceived Exertion (RPE)

  18 weeks

• Modified Ashworth Score (MAS)

  18 weeks

• Bone Mineral Density

  18 weeks

• Functional Reach

  18 weeks

Other Outcomes (3)

• Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)

  18 weeks

• Self-Report Survey

  18 weeks

• American Spinal Injury Association (ASIA) Impairment Scale

  18 weeks

Study Arms (1)

Interventional

OTHER

Walking in an exoskeleton within the home and community.

Device: Indego Exoskeleton

Interventions

Indego Exoskeleton DEVICE

Regular dosing of Indego Exoskeleton walking.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Size and limb proportions capable of fitting in the exoskeletal device :
• Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).
• Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).
• Body mass no greater than 114 kg (250 lb).
• "Poorly ambulatory" individual, defined as a person with FIM Gait 2- 6, who may be able to walk short distances with or without braces or stability aid, or may be able to walk with assistance of one person, but whose primary means of mobility is a manual or power-operated wheelchair.
• Sufficient upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
• Neurological injury level (NLI) T3 to L5 (between and inclusive).
• Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1 year.
• Sufficient bone health for walking with full weight-bearing without undue risk of fracture, as determined by each subject's personal medical doctor, and approved by each site's medical supervisor.
• 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.
• Skin intact where interfacing with robotic device.
• MAS for spasticity score 3 or less in lower extremities.
• Resting blood pressure and heart rate within established guidelines for locomotor training, specifically systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
• Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.

You may not qualify if:

• Heterotopic ossification that, in the opinion of the site medical supervisor, would place the subject at undue risk for fracture.
• Inability to follow instructions.
• Colostomy bag.
• Women who are pregnant or attempting to become pregnant during the course of the study. Note that a pregnancy test will be required and must be negative for all women prior to enrolling in the study, and will be additionally required and must be negative every four weeks during the course of the study protocol.
• Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
• Insufficient availability to complete study.
• Any other issue which, in the opinion of the investigators or medical supervisor, make the subject unsuitable for study participation.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (3)

Tampa VA

Tampa, Florida, 33637, United States

Location

Minnesota Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

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 Officials

• Michael Goldfarb, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Physical Medicine

Model Details: Poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: November 4, 2019
• Study Start: May 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

US (3)