NCT03082898

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

Completed NA Results posted Last updated 16 February 2022

What this trial tests

NA trial testing Indego Exoskeleton in Spinal Cord Injury in 41 participants. Completed in 1 June 2020.

Timeline

15 November 2016

Primary endpoint
1 June 2020

1 June 2020

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	41
Start date	15 November 2016
Primary completion	1 June 2020
Estimated completion	1 June 2020
Sites	3 locations across United States

Drugs / interventions tested

• Indego Exoskeleton

Conditions studied

• Spinal Cord Injury — all drugs for Spinal Cord Injury →

Sponsor

Vanderbilt University

Who can join

18 and older, any sex, with Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT) Primary · Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)

Measure of mobility (specifically gait speed) while wearing exoskeleton

10MWT at Session 11 (Week 5)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	38.3	33.7 – 49.1
AIS C or D Using Indego Exoskeleton	28.0	24.7 – 35.8

10MWT at Session 16 (Week 6)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	37.2	31.4 – 43.0
AIS C or D Using Indego Exoskeleton	27.9	25.0 – 33.4

10MWT at Session 24 (Week 9)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	34.3	30.3 – 44.3
AIS C or D Using Indego Exoskeleton	28.6	26.9 – 32.3

10MWT at Session 29 (Week 11)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	32.6	28.5 – 36.0
AIS C or D Using Indego Exoskeleton	28.9	27.5 – 31.7

The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT) Primary · Session 16 (Week 6) and Session 29 (Week 11)

Measure of gait speed over six minutes while wearing exoskeleton

6MWT at Session 16 (Week 6)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	288.9	223 – 332
AIS C or D Using Indego Exoskeleton	379	329 – 470

6MWT at Session 29 (Week 11)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	297	250 – 368
AIS C or D Using Indego Exoskeleton	390	341 – 400

Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test Secondary · Session 15 (Week 6), and Session 28 (Week 10)

Measure of ability to stand, walk, turn, and sit while wearing exoskeleton

TUG test at Session 15 (Week 6)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	87.2	67 – 108
AIS C or D Using Indego Exoskeleton	66	61.6 – 93.1

TUG test at Session 28 (Week 10)

Group	Value	95% CI
AIS A or B Using Indego Exoskeleton	84.3	61.9 – 98.5
AIS C or D Using Indego Exoskeleton	61.5	55.8 – 76.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Trials in Traumatic Spinal Cord Injury.
   Donovan J, Kirshblum S. · · 2018 · cited 68× · PMID 29736858 · DOI 10.1007/s13311-018-0632-5