Trial Outcomes & Findings for Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI). (NCT NCT02202538)

NCT ID: NCT02202538

Last Updated: 2017-07-25

Results Overview

The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-07-25

Participant Flow

Subjects were screened and enrolled at five sites in the United States

Participant milestones

Participant milestones
Measure	All Subjects All subjects enrolled in the study used the Indego
Overall Study STARTED	53
Overall Study Screen Failure	2
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All subjects enrolled in the study used the Indego
Overall Study Withdrawal by Subject	5
Overall Study Did not meet all inclusion criteria	2
Overall Study Investigator Decision	1

Baseline Characteristics

Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=53 Participants All subjects enrolled in the study used the Indego
Age, Continuous	35.9 years STANDARD_DEVIATION 13.0 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	42 Participants n=99 Participants
Region of Enrollment United States	53 participants n=99 Participants
Level of Injury T3	3 participants n=99 Participants
Level of Injury T4	9 participants n=99 Participants
Level of Injury T5	6 participants n=99 Participants
Level of Injury T6	5 participants n=99 Participants
Level of Injury T7	3 participants n=99 Participants
Level of Injury T8	6 participants n=99 Participants
Level of Injury T9	1 participants n=99 Participants
Level of Injury T10	7 participants n=99 Participants
Level of Injury T11	5 participants n=99 Participants
Level of Injury T12	5 participants n=99 Participants
Level of Injury L1	2 participants n=99 Participants
Level of Injury L2	1 participants n=99 Participants
ASIA Impairment Scale Score A	36 participants n=99 Participants
ASIA Impairment Scale Score B	5 participants n=99 Participants
ASIA Impairment Scale Score C	11 participants n=99 Participants
ASIA Impairment Scale Score D	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 8 weeks

Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)	95.6 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks, 8 weeks

Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study Average speed for 10MWT mid study	0.31 meters/second Standard Deviation 0.10
Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study Average speed for 10MWT end of study	0.37 meters/second Standard Deviation 0.09

PRIMARY outcome

Timeframe: 8 weeks

Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Timed Up and Go (TUG) Test	84.09 seconds Standard Deviation 20.41

PRIMARY outcome

Timeframe: 8 weeks

Time needed for an individual to don or doff the device.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Average Time to Don/Doff Device Average time to don device	9.3 minutes Standard Deviation 4.5
Average Time to Don/Doff Device Average time to doff device	2.6 minutes Standard Deviation 1.4

PRIMARY outcome

Timeframe: 8 weeks

The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Percentage of Subjects That Could Don/Doff the Device Independently Subjects that could don device independently	62.2 percentage
Percentage of Subjects That Could Don/Doff the Device Independently Subjects that could doff device independently	82.2 percentage

SECONDARY outcome

Timeframe: 8 weeks

Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury. 0:unable 1. parallel bars, braces, help of 2 persons,\<10m 2. parallel bars, braces, help of 2 persons,10m 3. parallel bars, braces, help of 1 person,10m 4. parallel bars, no braces, help of 1 person,10m 5. parallel bars, braces, no help,10m 6. walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m 8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m Reference: rehabmeasures.org

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Walking Index for Spinal Cord Injury (WISCI-II) Assessment	6.8 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 8 weeks

FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living. 7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance 1: total assistance Reference: rehabmeasures.org

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Functional Independence Measure (FIM) Score for Walking Indoors	4.3 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 8 weeks

The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task. 6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion

Outcome measures

Outcome measures
Measure	All Enrolled Subjects Who Completed the Study n=45 Participants All subjects in the study used the Indego
Borg Rating of Perceived Exertion (BRPE) for Walking Indoors	10.4 units on a scale Standard Deviation 2.2

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=53 participants at risk All subjects enrolled in the study used the Indego
Skin and subcutaneous tissue disorders Bruise	11.3% 6/53 • 8 weeks
Musculoskeletal and connective tissue disorders Pain	5.7% 3/53 • 8 weeks
Skin and subcutaneous tissue disorders Scrape/Cut/Abrasion	18.9% 10/53 • 8 weeks
Skin and subcutaneous tissue disorders Skin Redness	5.7% 3/53 • 8 weeks
Cardiac disorders Tachycardia	7.5% 4/53 • 8 weeks
Vascular disorders Hypertension	13.2% 7/53 • 8 weeks

Additional Information

Ryan Farris

Parker Hannifin Corporation

Phone: (216) 896-3335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place