Trial Outcomes & Findings for Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury (NCT NCT03355755)
NCT ID: NCT03355755
Last Updated: 2023-04-14
Results Overview
The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-04-14
Participant Flow
One arm study.
Participant milestones
| Measure |
Interventional Group
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
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|---|---|
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Overall Study
STARTED
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15
|
|
Overall Study
COMPLETED
|
13
|
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Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participants date of diagnosis was unknown and not analyzed
Baseline characteristics by cohort
| Measure |
Interventional Group
n=15 Participants
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=15 Participants
|
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Age, Categorical
>=65 years
|
4 Participants
n=15 Participants
|
|
Age, Continuous
|
50.87 years
STANDARD_DEVIATION 19.94 • n=15 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
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10 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
|
Region of Enrollment
United States
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15 participants
n=15 Participants
|
|
Days since diagnosis
|
93.62 days
STANDARD_DEVIATION 75.54 • n=14 Participants • One participants date of diagnosis was unknown and not analyzed
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 2 participants did not complete study protocol due to early discharge from hospital
The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.
Outcome measures
| Measure |
Interventional Group
n=13 Participants
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
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|---|---|
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Number of Participants Who Experience an Adverse Event During Time of Treatment
|
5 Participants
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SECONDARY outcome
Timeframe: 2 weeksPopulation: 2 participants did not complete study protocol due to early discharge from hospital
Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device.
Outcome measures
| Measure |
Interventional Group
n=13 Participants
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
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|---|---|
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Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related"
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2 Participants
|
Adverse Events
Interventional Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional Group
n=13 participants at risk
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
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|---|---|
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Injury, poisoning and procedural complications
Fall
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23.1%
3/13 • Number of events 3 • Adverse events were taken through the duration of the study (completing 5 sessions in exoskeleton) which took, on average, 12 days to complete.
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Skin and subcutaneous tissue disorders
skin tear and pressure sores
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15.4%
2/13 • Number of events 2 • Adverse events were taken through the duration of the study (completing 5 sessions in exoskeleton) which took, on average, 12 days to complete.
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Nervous system disorders
Spasm
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7.7%
1/13 • Number of events 1 • Adverse events were taken through the duration of the study (completing 5 sessions in exoskeleton) which took, on average, 12 days to complete.
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Skin and subcutaneous tissue disorders
Swelling and erythema
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7.7%
1/13 • Number of events 1 • Adverse events were taken through the duration of the study (completing 5 sessions in exoskeleton) which took, on average, 12 days to complete.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place