Trial Outcomes & Findings for Epi Stim to Facilitate Standing and Stepping (NCT NCT02339233)
NCT ID: NCT02339233
Last Updated: 2022-04-22
Results Overview
We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline, 160 sessions (1 year)
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Epidural Stimulator
n=8 Participants
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
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Age, Categorical
Between 18 and 65 years
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8 Participants
n=8 Participants
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Age, Categorical
>=65 years
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0 Participants
n=8 Participants
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Sex: Female, Male
Female
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1 Participants
n=8 Participants
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Sex: Female, Male
Male
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7 Participants
n=8 Participants
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PRIMARY outcome
Timeframe: Baseline, 160 sessions (1 year)We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
Outcome measures
| Measure |
Epidural Stimulator
n=8 Participants
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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|---|---|
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Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year)
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40.6 minutes
Standard Deviation 30.2
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PRIMARY outcome
Timeframe: Baseline, 160 session (1 year)We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
Outcome measures
| Measure |
Epidural Stimulator
n=8 Participants
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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|---|---|
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Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year)
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197.13 steps
Standard Deviation 421.89
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SECONDARY outcome
Timeframe: Baseline, 160 sessions (1 year)We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period
Outcome measures
| Measure |
Epidural Stimulator
n=8 Participants
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year)
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14.25 Repetitions
Standard Deviation 9.8
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Adverse Events
Epidural Stimulator
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epidural Stimulator
n=8 participants at risk
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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Surgical and medical procedures
Device Malfunction
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Musculoskeletal and connective tissue disorders
Hip Fracture
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Other adverse events
| Measure |
Epidural Stimulator
n=8 participants at risk
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
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Musculoskeletal and connective tissue disorders
Muscle Strain
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Surgical and medical procedures
Flipped Stimulator
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Surgical and medical procedures
Electrode Malfunction
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Skin and subcutaneous tissue disorders
Incision Site Drainage
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Musculoskeletal and connective tissue disorders
Right Ankle Edema
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12.5%
1/8 • Number of events 1 • From implant through the end of the second intervention, an average of one year.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place