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

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03082898
• Collaborator: (none)
• Enrollment: 41
• Locations: 3
• Arms: 2
• Actual Duration (Months): 42.5
• Patients Per Site: 13.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Device: Indego Exoskeleton	N/A

Detailed Description

Study Outline Study 1, as described herein, will assess the three hypotheses, i.e., health benefit, neurological recovery, and mobility benefits, in the context of regular dosing of exoskeleton walking in a clinical setting. These studies will be conducted at three study sites, Vanderbilt University Medical Center in Nashville TN, the James A. Haley Veterans Hospital in Tampa FL, and the Mayo Clinic in Rochester MN. All study sites will conduct an identical study protocol. The study will involve 24 non-ambulatory and poorly-ambulatory individuals with incomplete and complete SCI (i.e., 8 subjects at each site). In this study, "poorly ambulatory" is defined as persons with functional independence measure (FIM) gait score of 2 to 6 who may be able to walk short distances with or without braces and 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. Of the 24 individuals, half will be individuals with motor-complete injuries (i.e., American Spinal Injury Association Injury Scale, AIS, A or B), and half with motor-incomplete injuries (i.e., AIS C or D). As described subsequently in the Study Procedures section, the study will assess the therapeutic and functional effects of exoskeleton walking over an 8-week period of treatment, where the treatment consists of 3 walking sessions per week, each approximately 1.5 hours in duration for a total of 24 walking sessions. Therapeutic effects will be assessed via a number of measurements recorded primarily at study start, at the 4-week study midpoint, at the 8-week completion of treatment, and in a follow-up session, 8 weeks following the conclusion of treatment.

Study 2 will add 10 channels of functional electrical stimulation (FES )to the Indego exoskeleton , which include the quadriceps, hamstrings, gastrocnemius, and tibialis anterior muscle groups of each leg, in addition to a pair of trunk muscle channels. The nature of stimulation is fully consistent with standard-of-care FES units, although the timing and amplitude of the leg muscle stimulation is adjusted automatically by the exoskeleton, in a manner similar to the automated adjustment of stimulation in FES-aided cycling devices (also a standard intervention).

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2)
• Actual Study Start Date: Nov 15, 2016
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIS A or B using Indego Exoskeleton Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.	Device: Indego Exoskeleton; Regular dosing of Indego Exoskeleton walking.
Experimental: AIS C or D using Indego Exoskeleton Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.	Device: Indego Exoskeleton; Regular dosing of Indego Exoskeleton walking.

Outcome Measures

Primary Outcome Measures

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

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

   Measure of gait speed over six minutes while wearing exoskeleton

Secondary Outcome Measures

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)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.

• Sufficient responsiveness to FES in the quadriceps, hamstrings, tibialis anterior, and gastrocnemius, as defined by MMT in response to stimulation of 3 or greater on a 5-point MMT scale. Note that this is specifically for Study 2, but is included in Study 1 in order to economize study resources regarding enrollment, training, and assessment, as previously discussed.

• Access to a wireless internet connection. Note that is required only for Study 3, but is included in Study 1 in order to economize study resources regarding enrollment, training and assessment, as previously discussed.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa VA	Tampa	Florida	United States	FL 33637-1022
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Vanderbilt	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt University

Investigators

• Principal Investigator: Michael Goldfarb, MD, Vanderbilt University

Study Documents (Full-Text)

• Study Protocol - Feb 4, 2016
• Statistical Analysis Plan - Feb 4, 2016
• Informed Consent Form - Feb 4, 2016

More Information

Publications

None provided.

• Responsible Party: Michael Goldfarb, Professor Of Physical Medicine, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT03082898
• Other Study ID Numbers: SC140121
• First Posted: Mar 17, 2017
• Last Update Posted: Feb 16, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Pre-assignment Detail	Of the 41 participants enrolled, 2 were scheduled to start assessments in Tampa, but the study was cancelled due to COVID and not restarted at the Tampa site.

Arm/Group Title	AIS A or B Using Indego Exoskeleton	AIS C or D Using Indego Exoskeleton
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
Period Title: Overall Study
STARTED	27	12
COMPLETED	24	11
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	AIS A or B Using Indego Exoskeleton	AIS C or D Using Indego Exoskeleton	Total
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Total of all reporting groups
Overall Participants	24	11	35
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	11 100%	35 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 20.8%	3 27.3%	8 22.9%
Male	19 79.2%	8 72.7%	27 77.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
Description	Measure of mobility (specifically gait speed) while wearing exoskeleton
Time Frame	Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)

Outcome Measure Data

Analysis Population Description

One participant in the 'AIS A or B using Indego Exoskeleton' group missed the clinic visit for session 24 and we were unable to capture the 10MWT from this participant. One participant in the 'AIS C or D using Indego Exoskeleton' group missed the clinic visit for session 11 and we were unable to capture the 10MWT from this participant.

Arm/Group Title	AIS A or B Using Indego Exoskeleton	AIS C or D Using Indego Exoskeleton
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
Measure Participants	24	11
10MWT at Session 11 (Week 5)	38.3	28.0
10MWT at Session 16 (Week 6)	37.2	27.9
10MWT at Session 24 (Week 9)	34.3	28.6
10MWT at Session 29 (Week 11)	32.6	28.9

2. Primary Outcome

Title	The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)
Description	Measure of gait speed over six minutes while wearing exoskeleton
Time Frame	Session 16 (Week 6) and Session 29 (Week 11)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIS A or B Using Indego Exoskeleton	AIS C or D Using Indego Exoskeleton
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
Measure Participants	24	11
6MWT at Session 16 (Week 6)	288.9	379
6MWT at Session 29 (Week 11)	297	390

3. Secondary Outcome

Title	Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test
Description	Measure of ability to stand, walk, turn, and sit while wearing exoskeleton
Time Frame	Session 15 (Week 6), and Session 28 (Week 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIS A or B Using Indego Exoskeleton	AIS C or D Using Indego Exoskeleton
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.	Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
Measure Participants	24	11
TUG test at Session 15 (Week 6)	87.2	66
TUG test at Session 28 (Week 10)	84.3	61.5

Adverse Events

Time Frame	From date of randomization to the follow-up visit at week 18 (session 31)
Adverse Event Reporting Description	Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	AIS A or B Using Indego Exoskeleton		AIS C or D Using Indego Exoskeleton
Arm/Group Description	Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of Indego Exoskeleton walking.		Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of Indego Exoskeleton walking.
All Cause Mortality
	AIS A or B Using Indego Exoskeleton		AIS C or D Using Indego Exoskeleton
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/11 (0%)
Serious Adverse Events
	AIS A or B Using Indego Exoskeleton		AIS C or D Using Indego Exoskeleton
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	AIS A or B Using Indego Exoskeleton		AIS C or D Using Indego Exoskeleton
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.