Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2)

NCT03082898 | Completed Results DMC

• 1 other identifier: SC140121
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)

  Measure of mobility (specifically gait speed) while wearing exoskeleton

  Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)

• The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)

  Measure of gait speed over six minutes while wearing exoskeleton

  Session 16 (Week 6) and Session 29 (Week 11)

Secondary Outcomes (1)

• Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test

  Session 15 (Week 6), and Session 28 (Week 10)

Study Arms (2)

AIS A or B using Indego Exoskeleton

EXPERIMENTAL

Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.

Device: Indego Exoskeleton

AIS C or D using Indego Exoskeleton

EXPERIMENTAL

Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.

Device: Indego Exoskeleton

Interventions

Indego Exoskeleton DEVICE

Regular dosing of Indego Exoskeleton walking.

AIS A or B using Indego Exoskeleton; AIS C or D using Indego Exoskeleton

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).
• Non-ambulatory or poorly-ambulatory. In this study, "non-ambulatory" is defined as a person who cannot walk, or is classified with a Functional Independence Measure (FIM) Gait score 1; "poorly ambulatory" is 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 a appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
• For Study 1 Present with SCI and NLI C5 or lower, with AIS A, B, C or D (as per the International Standard for Neurological Classification of SCI, ISNCSCI), who are non-ambulatory or poorly ambulatory.
• For Study 2: Present with SCI AIS classification A or B at neurological injury level (NLI) T4 or below, or with AIS classification C or D at neurological injury level C5 or below.
• 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: At rest: systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less. During exercise: systolic 180 mmHg or less, diastolic 105 mmHg or less, heart rate 145 bpm or less for Study 1.

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, FL 33637-1022, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Vanderbilt

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

Results Point of Contact

• Title: Dr. Michael Goldfarb
• Organization: Vanderbilt University

michael.goldfarb@vanderbilt.edu

615 343 6924

Study Officials

• Michael Goldfarb, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 17, 2017
• Study Start: November 15, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 16, 2022
• Results First Posted: February 16, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)