Trial Outcomes & Findings for Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons (NCT NCT03011099)
NCT ID: NCT03011099
Last Updated: 2018-04-03
Results Overview
The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
baseline, week 4
Results posted on
2018-04-03
Participant Flow
One participant dropped out of the study after signing the consent before randomization.
Participant milestones
| Measure |
Robotic Exoskeleton Training
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
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Conventional Physical Therapy
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Overall Study
STARTED
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6
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5
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Overall Study
COMPLETED
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6
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3
|
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Overall Study
NOT COMPLETED
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0
|
2
|
Reasons for withdrawal
| Measure |
Robotic Exoskeleton Training
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
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Conventional Physical Therapy
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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Overall Study
Withdrawal by Subject
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0
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2
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Baseline Characteristics
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Baseline characteristics by cohort
| Measure |
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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Total
n=9 Participants
Total of all reporting groups
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Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
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4 Participants
n=5 Participants
|
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Region of Enrollment
United States
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3 participants
n=7 Participants
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9 participants
n=5 Participants
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6 participants
n=5 Participants
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PRIMARY outcome
Timeframe: baseline, week 4The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
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-6.815 seconds
Standard Deviation 9.58
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-0.5 seconds
Standard Deviation 4.02
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PRIMARY outcome
Timeframe: baseline, week 4The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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Change in Walking Endurance as Assessed by the 6 Minute Walk Test
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34.3833 feet
Standard Deviation 42.83
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25.3 feet
Standard Deviation 25.96
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PRIMARY outcome
Timeframe: baseline, week 4The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
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-10.575 Second
Standard Deviation 17.31
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-1.59 Second
Standard Deviation 0.44
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PRIMARY outcome
Timeframe: baseline, week 4Population: This measure was later added to the protocol and hence data was collected from one participant only.
Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=1 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in Vastus Medialis activity
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-18 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in soleus activity
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-44 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in gastrocnemius activity
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-37 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in tibialis anterior activity
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57 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in Rectus Femoris activity
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12 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in Bicep Femoris activity
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33 percentage of muscle activity change
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—
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Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Change in Semitendinosus activity
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32 percentage of muscle activity change
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—
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PRIMARY outcome
Timeframe: baseline, week 4Population: The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.
Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=2 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
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-0.84 ml/min/kg
Standard Deviation 0.56
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—
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SECONDARY outcome
Timeframe: baseline, week 4Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
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0.12 steps/min
Standard Deviation 0.17
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0.08 steps/min
Standard Deviation 0.11
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SECONDARY outcome
Timeframe: baseline, week 4Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
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0.04 cm
Standard Deviation 0.11
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-0.03 cm
Standard Deviation 0.08
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SECONDARY outcome
Timeframe: baseline, week 4Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
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-0.09 seconds
Standard Deviation 0.13
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-0.02 seconds
Standard Deviation 0.11
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SECONDARY outcome
Timeframe: baseline, week 4The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis 1. = palpable or visible contraction 2. = active movement, full range of motion (ROM) with gravity eliminated 3. = active movement, full ROM against gravity 4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position 5. = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
n=3 Participants
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
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0.42 units on a scale
Standard Deviation 2.15
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-0.17 units on a scale
Standard Deviation 0.41
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SECONDARY outcome
Timeframe: week 4Population: This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.
A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
Outcome measures
| Measure |
Robotic Exoskeleton Training
n=6 Participants
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
|
Conventional Physical Therapy
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
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|---|---|---|
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Exoskeleton User Feedback as Assessed by a Questionnaire
|
1.83 units on a scale
Standard Deviation 0.75
|
—
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Adverse Events
Robotic Exoskeleton Training
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conventional Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Robotic Exoskeleton Training
n=6 participants at risk
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
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Conventional Physical Therapy
n=3 participants at risk
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
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|---|---|---|
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Musculoskeletal and connective tissue disorders
swelling and pain in foot
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected for each participant during their participation in the study. the study protocol was 1 month long.
|
0.00%
0/3 • Adverse event data were collected for each participant during their participation in the study. the study protocol was 1 month long.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place