Trial Outcomes & Findings for Powered Exoskeletons in Persons With SCI (NCT NCT02658656)

Last Updated: 2024-11-04

Results Overview

Number of randomized participants with a greater than or equal to 4 point change on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

Recruitment status

COMPLETED

Study phase

Target enrollment

424 participants

Primary outcome timeframe

Change from Baseline Assessment to 4 Months Post Intervention

Results posted on

2024-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Exoskeleton + Standard of Care (SOC) Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care Patient will receive standard of care (wheelchair use)	Screen Failures Consented participants who failed screening and were not randomized.
Screening STARTED	78	83	263
Screening COMPLETED	78	83	0
Screening NOT COMPLETED	0	0	263
Randomization STARTED	78	83	0
Randomization COMPLETED	45	57	0
Randomization NOT COMPLETED	33	26	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Exoskeleton + Standard of Care (SOC) Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care Patient will receive standard of care (wheelchair use)	Screen Failures Consented participants who failed screening and were not randomized.
Screening Failed eligibility criteria	0	0	263
Randomization Withdrawal by Subject	8	7	0
Randomization Lost to Follow-up	1	3	0
Randomization Adverse Event	4	0	0
Randomization Administrative Termination	3	1	0
Randomization Administrative Termination due to COVID-19 Restrictions	13	15	0
Randomization Failed Exoskeletal-assisted walking (EAW) Advanced Skills Test	2	0	0
Randomization Not eligible for Randomization	1	0	0
Randomization Protocol Violation	1	0	0

Baseline Characteristics

Powered Exoskeletons in Persons With SCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exoskeleton + SOC n=78 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 Participants Patient will receive standard of care (wheelchair use)	Total n=161 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 13.61 • n=113 Participants	46.2 years STANDARD_DEVIATION 13.27 • n=163 Participants	46.2 years STANDARD_DEVIATION 13.4 • n=160 Participants
Sex: Female, Male Female	6 Participants n=113 Participants	4 Participants n=163 Participants	10 Participants n=160 Participants
Sex: Female, Male Male	72 Participants n=113 Participants	79 Participants n=163 Participants	151 Participants n=160 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=113 Participants	19 Participants n=163 Participants	27 Participants n=160 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=113 Participants	63 Participants n=163 Participants	129 Participants n=160 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=113 Participants	1 Participants n=163 Participants	5 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=113 Participants	0 Participants n=163 Participants	2 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	1 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	14 Participants n=113 Participants	13 Participants n=163 Participants	27 Participants n=160 Participants
Race (NIH/OMB) White	55 Participants n=113 Participants	54 Participants n=163 Participants	109 Participants n=160 Participants
Race (NIH/OMB) More than one race	6 Participants n=113 Participants	13 Participants n=163 Participants	19 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=113 Participants	2 Participants n=163 Participants	3 Participants n=160 Participants
Region of Enrollment United States	78 Participants n=113 Participants	83 Participants n=163 Participants	161 Participants n=160 Participants
Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36)	60.6 units on a scale STANDARD_DEVIATION 10.85 • n=113 Participants	59.2 units on a scale STANDARD_DEVIATION 11.71 • n=163 Participants	59.9 units on a scale STANDARD_DEVIATION 11.29 • n=160 Participants
SCI-QOL Physical Medical Health Domain	153 units on a scale STANDARD_DEVIATION 21.11 • n=113 Participants	153 units on a scale STANDARD_DEVIATION 23.93 • n=163 Participants	153 units on a scale STANDARD_DEVIATION 22.54 • n=160 Participants

PRIMARY outcome

Timeframe: Change from Baseline Assessment to 4 Months Post Intervention

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=78 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 Participants Patient will receive standard of care (wheelchair use)
Improvement on the MCS in All Randomized Participants	12 Participants	14 Participants

PRIMARY outcome

Timeframe: Change from Baseline Assessment to 4 Months Post Intervention

Population: All randomized participants

Number of randomized participants with a greater than or equal to 10 percent decrease on the SCI-QOL Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=78 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 Participants Patient will receive standard of care (wheelchair use)
Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Population: All randomized participants

Number of randomized participants with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=78 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 Participants Patient will receive standard of care (wheelchair use)
Total Body Fat Loss in All Randomized Participants	14 Participants	16 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Population: Participants who completed the 4 month intervention phase

Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 4 point increase on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=57 Participants Patient will receive standard of care (wheelchair use)
Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.	12 Participants	14 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Population: Participants that completed the 4 month intervention phase

Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 10 percent improvement (decrease) on the Spinal Cord Injury Quality of Life (SCI-QOL) Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=57 Participants Patient will receive standard of care (wheelchair use)
Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.	10 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Population: participants who completed the 4 month intervention phase

Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=57 Participants Patient will receive standard of care (wheelchair use)
Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.	14 Participants	16 Participants

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a Mental Health Component Summary (MCS) score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in Mental Health Component Summary (MCS) Post training/orientation	1.7 score on a scale Standard Deviation 9.57	-0.3 score on a scale Standard Deviation 7.32
Change in Mental Health Component Summary (MCS) 2 month post intervention	1.0 score on a scale Standard Deviation 8.04	-1.0 score on a scale Standard Deviation 8.42
Change in Mental Health Component Summary (MCS) 4 month post intervention	-0.1 score on a scale Standard Deviation 10.40	-1.8 score on a scale Standard Deviation 10.38

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a PMH score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the SCI-QOL Physical Medical Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in SCI-QOL Physical Medical Health Domain Post training/orientation	-4.4 score on a scale Standard Deviation 17.60	-0.5 score on a scale Standard Deviation 16.59
Change in SCI-QOL Physical Medical Health Domain 2 month post intervention	-5.9 score on a scale Standard Deviation 15.56	-1.7 score on a scale Standard Deviation 17.73
Change in SCI-QOL Physical Medical Health Domain 4 month post intervention	-6.9 score on a scale Standard Deviation 17.71	-1.5 score on a scale Standard Deviation 19.99

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a total body fat measurement at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in total body fat from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in Total Body Fat Post training/orientation	0.2 kilograms Standard Deviation 2.01	0.3 kilograms Standard Deviation 1.82
Change in Total Body Fat 2 month post intervention	0.4 kilograms Standard Deviation 3.13	0.1 kilograms Standard Deviation 2.84
Change in Total Body Fat 4 month post intervention	0.1 kilograms Standard Deviation 3.75	0.1 kilograms Standard Deviation 3.59

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a Social Health Domain score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the SCI-QOL Social Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Social Health Domain score is a sum of the SCI-QOL scores from the ability to participate in social roles and activities, satisfaction with social roles and activities, and independence item banks. Possible range of the Social Health Domain score is 78 to 191, with a higher score indicating higher social health.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=52 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=74 Participants Patient will receive standard of care (wheelchair use)
Change in SCI-QOL Social Participation Domain post training/orientation	1.9 score on a scale Standard Deviation 14.74	-2.0 score on a scale Standard Deviation 13.58
Change in SCI-QOL Social Participation Domain 2 month post intervention	-0.2 score on a scale Standard Deviation 17.13	-2.2 score on a scale Standard Deviation 13.45
Change in SCI-QOL Social Participation Domain 4 month post intervention	4.1 score on a scale Standard Deviation 15.00	-3.0 score on a scale Standard Deviation 16.59

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a score on the SCI-QOL Positive Emotional Constraints at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the SCI-QOL Positive Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Positive Emotional Constraints score is a sum of the SCI-QOL scores from the positive affect and well being, self-esteem, and resilience item banks. Possible range of the Positive Emotional Constraints score is 63 to 199, with a higher score indicating better emotional wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in SCI-QOL Positive Emotional Constraints Post Training/Orientation	0.1 score on a scale Standard Deviation 17.72	-2.3 score on a scale Standard Deviation 16.87
Change in SCI-QOL Positive Emotional Constraints 2 months post intervention	1.7 score on a scale Standard Deviation 16.28	-1.8 score on a scale Standard Deviation 16.71
Change in SCI-QOL Positive Emotional Constraints 4 months post intervention	2.6 score on a scale Standard Deviation 14.99	-3.2 score on a scale Standard Deviation 20.63

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a score on SCI-QOL Negative Emotional Constraints at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the SCI-QOL Negative Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Negative Emotional Constraints score is a sum of the SCI-QOL scores from the anxiety, depression, grief-loss, trauma, and stigma item banks. Possible range of the Negative Emotional Constraints score is 182 to 405, with a lower score indicating better emotional wellbeing.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=74 Participants Patient will receive standard of care (wheelchair use)
Change in SCI-QOL Negative Emotional Constraints post training/orientation	-6.5 Score on a scale Standard Deviation 25.20	3.6 Score on a scale Standard Deviation 22.42
Change in SCI-QOL Negative Emotional Constraints 2 months post intervention	-8.4 Score on a scale Standard Deviation 21.83	1.1 Score on a scale Standard Deviation 22.05
Change in SCI-QOL Negative Emotional Constraints 4 months post intervention	-8.6 Score on a scale Standard Deviation 22.34	1.5 Score on a scale Standard Deviation 26.91

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a score on the SCI FI at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference score in the SCI Functional Index (FI) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The SCI Function Index for physical function is a sum of the basic mobility, ambulation, fine motor, self-care, and wheelchair mobility item banks. Possible range of the SCI Functional Index is 188 to 408, with a higher score indicating better physical function.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=21 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=23 Participants Patient will receive standard of care (wheelchair use)
Change in SCI Functional Index (FI) Post Training/Orientation	5.4 score on a scale Standard Deviation 20.97	-5.8 score on a scale Standard Deviation 11.63
Change in SCI Functional Index (FI) Two months post intervention	7.3 score on a scale Standard Deviation 16.00	-4.5 score on a scale Standard Deviation 12.99
Change in SCI Functional Index (FI) 4 months post intervention	3.8 score on a scale Standard Deviation 16.36	-8.6 score on a scale Standard Deviation 20.60

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized with a score on the PROMIS Sleep Disturbance score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference T-score of the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the PROMIS is 28.9 to 76.5, with a higher score indicating more sleep disturbance.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=74 Participants Patient will receive standard of care (wheelchair use)
Change in Sleep Disturbance 4 months post intervention	-0.3 Score on a scale Standard Deviation 9.91	1.3 Score on a scale Standard Deviation 7.58
Change in Sleep Disturbance Post Training/Orientation	-1.8 Score on a scale Standard Deviation 8.83	2.1 Score on a scale Standard Deviation 7.57
Change in Sleep Disturbance 2 months post intervention	-2.1 Score on a scale Standard Deviation 8.75	1.6 Score on a scale Standard Deviation 7.50

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with an impression of severity score on the Global Impression of Change Scale at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference in the participant impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the participant impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in Participant Impression of Severity Post Training/Orientation	-0.2 score on a scale Standard Deviation 1.10	0.4 score on a scale Standard Deviation 1.06
Change in Participant Impression of Severity 2 months post intervention	0.0 score on a scale Standard Deviation 1.01	0.3 score on a scale Standard Deviation 1.13
Change in Participant Impression of Severity 4 months post intervention	-0.1 score on a scale Standard Deviation 1.17	0.3 score on a scale Standard Deviation 1.16

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a companion impression of severity score on the Global Impression of Change Scale at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Mean difference in the companion impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the companion impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=52 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=72 Participants Patient will receive standard of care (wheelchair use)
Change in Companion Impression of Severity Post Training/Orientation	0.0 score on a scale Standard Deviation 1.30	0.0 score on a scale Standard Deviation 1.13
Change in Companion Impression of Severity Two months post intervention	0.2 score on a scale Standard Deviation 1.55	0.3 score on a scale Standard Deviation 1.48
Change in Companion Impression of Severity 4 months post intervention	0.2 score on a scale Standard Deviation 1.28	0.3 score on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: 4 months post intervention

Time spent to have a bowel movement per bowel day, over 7 days. Responses were collected using a 5-point likert scale with the following options: 5 to 15 minutes; 15 to 30 minutes; 30 to 60 minutes; 1 to 3 hours; more than 3 hours.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=56 Participants Patient will receive standard of care (wheelchair use)
Bowel Evacuation Time 5 to 15 minutes	14 Participants	8 Participants
Bowel Evacuation Time 15 to 30 minutes	10 Participants	14 Participants
Bowel Evacuation Time 30 to 60 minutes	10 Participants	22 Participants
Bowel Evacuation Time 1 to 3 hours	10 Participants	11 Participants
Bowel Evacuation Time More than 3 hours	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Frequency of bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: 7 times or more; 5 to 6 times; 3 to 4 times; 1 to 2 times; none.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=55 Participants Patient will receive standard of care (wheelchair use)
Frequency of Bowel Evacuation Episodes 7 times or more	18 Participants	23 Participants
Frequency of Bowel Evacuation Episodes 5-6 times	7 Participants	9 Participants
Frequency of Bowel Evacuation Episodes 3-4 times	16 Participants	16 Participants
Frequency of Bowel Evacuation Episodes 1-2 times	4 Participants	6 Participants
Frequency of Bowel Evacuation Episodes None	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Needed manual/digit stimulation for bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=56 Participants Patient will receive standard of care (wheelchair use)
Manual/Digit Stimulation for Bowel Movements A few times	5 Participants	6 Participants
Manual/Digit Stimulation for Bowel Movements Most times	4 Participants	4 Participants
Manual/Digit Stimulation for Bowel Movements None/never	11 Participants	11 Participants
Manual/Digit Stimulation for Bowel Movements Only once	1 Participants	3 Participants
Manual/Digit Stimulation for Bowel Movements Every time	24 Participants	32 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Required oral medications to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=56 Participants Patient will receive standard of care (wheelchair use)
Oral Medications for Bowel Movements None/never	22 Participants	33 Participants
Oral Medications for Bowel Movements Only once	1 Participants	3 Participants
Oral Medications for Bowel Movements A few times	6 Participants	2 Participants
Oral Medications for Bowel Movements Most times	3 Participants	2 Participants
Oral Medications for Bowel Movements Every time	13 Participants	16 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Required enemas or irrigations to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=56 Participants Patient will receive standard of care (wheelchair use)
Enemas or Irrigations for Bowel Movements A few times	4 Participants	4 Participants
Enemas or Irrigations for Bowel Movements None/never	30 Participants	33 Participants
Enemas or Irrigations for Bowel Movements Only once	1 Participants	4 Participants
Enemas or Irrigations for Bowel Movements Most times	1 Participants	2 Participants
Enemas or Irrigations for Bowel Movements Every time	9 Participants	13 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Bowel accidents over 7 days. Responses were collected using a 5-point Likert scale with the following options: no leakage or accidents; leakage or an accident 1-2 times; leakage or an accident 3-4 times; leakage or an accident 5-6 times; leakage or an accident 7 or more times.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=45 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=56 Participants Patient will receive standard of care (wheelchair use)
Bowel Control Leakage or an accident 7 or more times	0 Participants	1 Participants
Bowel Control No leakage or accidents	31 Participants	43 Participants
Bowel Control Leakage or an accident 1-2 times	12 Participants	11 Participants
Bowel Control Leakage or an accident 3-4 times	2 Participants	1 Participants
Bowel Control Leakage or an accident 5-6 times	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months post intervention

Stool consistency by the Bristol Stool Scale over 7 days. The Bristol Stool Scale classifies stools into seven groups: separate hard lumps; sausage-shaped, but lumpy; like sausage, cracks on surface; like a snake, smooth and soft; soft blobs (passed easily); fluffy pieces, a mush stool; watery, entirely liquid.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=42 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=55 Participants Patient will receive standard of care (wheelchair use)
Stool Consistency Separate hard lumps	1 Participants	4 Participants
Stool Consistency Sausage-shaped, but lumpy	5 Participants	10 Participants
Stool Consistency Like sausage, cracks on surface	13 Participants	14 Participants
Stool Consistency Like a snake, smooth and soft	11 Participants	21 Participants
Stool Consistency Soft blobs (passed easily)	5 Participants	2 Participants
Stool Consistency Fluffy pieces, a mush stool	7 Participants	2 Participants
Stool Consistency Watery, entirely liquid	0 Participants	2 Participants

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a bone density scan at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in visceral adipose tissue mass measured from bone density scan, in grams, from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=54 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=73 Participants Patient will receive standard of care (wheelchair use)
Change in Abdominal Fat Mass Post Training/Orientation	57 grams Standard Deviation 269.4	30 grams Standard Deviation 247.8
Change in Abdominal Fat Mass Two months post intervention	93 grams Standard Deviation 351.6	2 grams Standard Deviation 247.4
Change in Abdominal Fat Mass 4 months post intervention	67 grams Standard Deviation 360.2	21 grams Standard Deviation 273.4

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a high density lipoprotein cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in high density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=49 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=66 Participants Patient will receive standard of care (wheelchair use)
Change in High Density Lipoprotein Cholesterol Post Training/Orientation	0.8 mg/dL Standard Deviation 6.55	-0.6 mg/dL Standard Deviation 8.66
Change in High Density Lipoprotein Cholesterol Two Months post intervention	1.3 mg/dL Standard Deviation 6.42	0.2 mg/dL Standard Deviation 8.11
Change in High Density Lipoprotein Cholesterol 4 months post intervention	0.7 mg/dL Standard Deviation 7.3	-0.3 mg/dL Standard Deviation 7.5

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a low density lipoprotein cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in low density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=48 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=65 Participants Patient will receive standard of care (wheelchair use)
Change in Low Density Lipoprotein Cholesterol Post training/Orientation	-2.9 mg/dL Standard Deviation 24.26	1.2 mg/dL Standard Deviation 28.49
Change in Low Density Lipoprotein Cholesterol Two months post intervention	-0.6 mg/dL Standard Deviation 21.15	-0.7 mg/dL Standard Deviation 21.13
Change in Low Density Lipoprotein Cholesterol 4 months post intervention	-2.4 mg/dL Standard Deviation 20.77	1.8 mg/dL Standard Deviation 23.97

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a total cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in total cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=49 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=66 Participants Patient will receive standard of care (wheelchair use)
Change in Total Cholesterol Post Training/Orientation	2.9 mg/dL Standard Deviation 32.44	0.0 mg/dL Standard Deviation 31.42
Change in Total Cholesterol Two months post intervention	2.6 mg/dL Standard Deviation 31.93	1.4 mg/dL Standard Deviation 26.08
Change in Total Cholesterol 4 Months post intervention	4.8 mg/dL Standard Deviation 36.71	1.1 mg/dL Standard Deviation 29.65

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with a triglycerides lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in triglycerides, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=49 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=66 Participants Patient will receive standard of care (wheelchair use)
Change in Triglycerides Post Training/Orientation	3.9 mg/dL Standard Deviation 61.78	4.0 mg/dL Standard Deviation 57.37
Change in Triglycerides Two months post intervention	3.0 mg/dL Standard Deviation 68.36	9.5 mg/dL Standard Deviation 68.17
Change in Triglycerides 4 months post intervention	14.9 mg/dL Standard Deviation 104.2	-2.3 mg/dL Standard Deviation 61.12

SECONDARY outcome

Timeframe: post training/orientation, two months post intervention, and 4 months post intervention.

Population: Randomized participants with fasting insulin and fasting glucose lab values at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to post training/orientation, two months post intervention, and 4 months post intervention. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.

Outcome measures

Outcome measures
Measure	Exoskeleton + SOC n=51 Participants Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=65 Participants Patient will receive standard of care (wheelchair use)
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) 4 months post intervention	1.7 units on a scale Standard Deviation 8.11	0.3 units on a scale Standard Deviation 3.7
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Post Training/Orientation	1.1 units on a scale Standard Deviation 3.94	0.1 units on a scale Standard Deviation 2.68
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Two months post intervention	2.3 units on a scale Standard Deviation 11.4	0.1 units on a scale Standard Deviation 4.27

Adverse Events

Exoskeleton + SOC

Serious events: 11 serious events

Other events: 54 other events

Deaths: 0 deaths

Standard of Care

Serious events: 14 serious events

Other events: 44 other events

Deaths: 0 deaths

Prior to Randomization

Serious events: 27 serious events

Other events: 86 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Ann Spungen, Study Chairperson

James J Peters VA Medical Center

Phone: 7185849000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Exoskeleton + SOC n=78 participants at risk Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 participants at risk Patient will receive standard of care (wheelchair use)	Prior to Randomization n=424 participants at risk Consented patients prior to randomization
Nervous system disorders Carpal tunnel syndrome	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Nervous system disorders Muscle spasticity	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Nervous system disorders Seizure	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Cardiac disorders Cardiac arrest	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Constipation	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Haematochezia	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Adverse drug reaction	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Pain	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Pyrexia	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Immune system disorders Seasonal allergy	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Cystitis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Diverticulitis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Gastroenteritis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Influenza	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Pneumonia	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Urinary tract infection	2.6% 2/78 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	3.6% 3/83 • Number of events 5 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.4% 6/424 • Number of events 6 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Urosepsis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Viral upper respiratory tract infection	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Injury, poisoning and procedural complications Fall	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Injury, poisoning and procedural complications Femur fracture	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Injury, poisoning and procedural complications Foot fracture	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Investigations Colonoscopy	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large-cell lymphoma	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Nervous system disorders Syncope	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Psychiatric disorders Alcohol abuse	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Psychiatric disorders Drug use disorder	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Psychiatric disorders Self-injurious ideation	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Renal and urinary disorders Nephrolithiasis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.47% 2/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Surgical and medical procedures Botulinum toxin injection	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Surgical and medical procedures Heart valve operation	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Surgical and medical procedures Hospitalisation	1.3% 1/78 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	4.8% 4/83 • Number of events 11 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.4% 6/424 • Number of events 7 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Surgical and medical procedures Medical device implantation	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Surgical and medical procedures Penile prosthesis insertion	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.

Other adverse events
Measure	Exoskeleton + SOC n=78 participants at risk Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device	Standard of Care n=83 participants at risk Patient will receive standard of care (wheelchair use)	Prior to Randomization n=424 participants at risk Consented patients prior to randomization
Cardiac disorders Cardiac arrest	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Cardiac disorders Sinus tachycardia	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Congenital, familial and genetic disorders Syringomyelia	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Eye disorders Eye irritation	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Abdominal discomfort	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	4.8% 4/83 • Number of events 4 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.47% 2/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Abdominal distension	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Anal incontinence	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Constipation	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.47% 2/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Dental caries	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Diarrhoea	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Haematochezia	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.47% 2/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Haemorrhoids	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Nausea	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Catheter site haemorrhage	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Chest pain	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Chills	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Cyst	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Fatigue	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Granuloma	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Influenza like illness	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Malaise	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	2.4% 2/83 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Medical device site bruise	2.6% 2/78 • Number of events 5 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	2.1% 9/424 • Number of events 11 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Medical device site erythema	2.6% 2/78 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Medical device site haematoma	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Medical device site injury	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Medical device site pain	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Oedema peripheral	3.8% 3/78 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Pain	3.8% 3/78 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.47% 2/424 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Peripheral swelling	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
General disorders Pyrexia	2.6% 2/78 • Number of events 2 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Immune system disorders Seasonal allergy	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.24% 1/424 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Conjunctivitis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Cystitis	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Ear infection	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Fungal skin infection	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Gastroenteritis	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	3.6% 3/83 • Number of events 4 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Influenza	3.8% 3/78 • Number of events 3 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Lower respiratory tract infection	0.00% 0/78 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	1.2% 1/83 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Infections and infestations Medical device site infection	1.3% 1/78 • Number of events 1 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/83 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.	0.00% 0/424 • From consent to 4 month post intervention. Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.