Trial Outcomes & Findings for Spinal Cord Injury Leg Rehabilitation (NCT NCT01498991)
NCT ID: NCT01498991
Last Updated: 2019-05-24
Results Overview
Measured by the GAITRite system
TERMINATED
PHASE1/PHASE2
2 participants
Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
2019-05-24
Participant Flow
Participant milestones
| Measure |
AMES Treatment
The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.
AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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2
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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
Spinal Cord Injury Leg Rehabilitation
Baseline characteristics by cohort
| Measure |
AMES Treatment
n=2 Participants
The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.
AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).
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|---|---|
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Age, Continuous
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30 years
STANDARD_DEVIATION 1.5 • n=93 Participants
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Sex: Female, Male
Female
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1 Participants
n=93 Participants
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Sex: Female, Male
Male
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1 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=93 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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1 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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2 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Measured by the GAITRite system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Measured by the GAITRite system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to each treatment session, on average 3 times a weekPopulation: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to each treatment session, on average 3 times a weekPopulation: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
AMES Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place