Trial Outcomes & Findings for Reducing Asymmetry During Gait Using the TPAD (Tethered Pelvic Assist Device) for Stroke Patients (NCT NCT03203291)
NCT ID: NCT03203291
Last Updated: 2020-06-09
Results Overview
0-1 symmetry ratio comparing the impulse force of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline through day 5
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
TPAD Treatment
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
TPAD Treatment
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Age, Customized
Age
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50.18 years
STANDARD_DEVIATION 11.08 • n=11 Participants
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Sex: Female, Male
Female
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5 Participants
n=11 Participants
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Sex: Female, Male
Male
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6 Participants
n=11 Participants
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Region of Enrollment
United States
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11 participants
n=11 Participants
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Months Since Stroke
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71.24 months
STANDARD_DEVIATION 46.70 • n=11 Participants
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PRIMARY outcome
Timeframe: Baseline through day 50-1 symmetry ratio comparing the impulse force of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Force Symmetry Ratio During Gait
Baseline
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0.71 ratio
Standard Deviation 0.09
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Force Symmetry Ratio During Gait
Day 5
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0.83 ratio
Standard Deviation 0.23
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PRIMARY outcome
Timeframe: Baseline through week 30-1 symmetry ratio of the percentage of time spent in the stance phase of a gait cycle. If the unaffected limb performs equivalent to the affected limb, the ratio will have a value of 1. The greater the disparity the closer the ratio is to 0. Stance time symmetry = Time in stance phase of gait cycle of Affected/Unaffected limb.
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Stance Time Symmetry Ratio
Baseline
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0.81 ratio
Standard Deviation 0.04
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Stance Time Symmetry Ratio
Day 5
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0.86 ratio
Standard Deviation 0.05
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Stance Time Symmetry Ratio
Week 3
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0.83 ratio
Standard Deviation 0.05
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SECONDARY outcome
Timeframe: Baseline through week 30-1 symmetry ratio comparing the stride length of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Symmetry Ratio of Stride Length
Baseline
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1.04 ratio
Standard Deviation 0.05
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Symmetry Ratio of Stride Length
Day 5
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1.06 ratio
Standard Deviation 0.08
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Symmetry Ratio of Stride Length
Week 3
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1.03 ratio
Standard Deviation 0.05
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SECONDARY outcome
Timeframe: Baseline through week 3Walking velocity (speed) measured in meters walked per second (measured by Inertial Measurement Unit sensors worn in real time during walking).
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Gait Velocity
Baseline
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0.56 meters/second
Standard Deviation 0.22
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Gait Velocity
Day 5
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0.57 meters/second
Standard Deviation 0.20
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Gait Velocity
Week 3
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0.59 meters/second
Standard Deviation 0.25
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SECONDARY outcome
Timeframe: Baseline through week 30-1 symmetry ratio compares the amount of time the unaffected leg is in swing phase of the gait cycle compared to the affected leg. The swing phase means the period of time during the gait cycle when one foot is not in contact with the ground. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Symmetry of Percentage of Time in Swing Phase of Gait
Baseline
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0.66 ratio
Standard Deviation 0.11
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Symmetry of Percentage of Time in Swing Phase of Gait
Day 5
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0.73 ratio
Standard Deviation 0.11
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Symmetry of Percentage of Time in Swing Phase of Gait
Week 3
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0.68 ratio
Standard Deviation 0.12
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SECONDARY outcome
Timeframe: Baseline through week 3The percentage of time in one gait cycle spent in double support phase of gait (2 feet in contact with the ground).
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Time Spent in Double Support Phase of Gait
Baseline
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31.62 percentage of gait cycle
Standard Deviation 9.74
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Time Spent in Double Support Phase of Gait
Day 5
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34.12 percentage of gait cycle
Standard Deviation 8.53
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Time Spent in Double Support Phase of Gait
Week 3
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31.76 percentage of gait cycle
Standard Deviation 10.38
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SECONDARY outcome
Timeframe: Baseline through week 3Berg Balance Scale measures balance ability of adults. The scale has 14 items, each is rated on a 5-point scale ranging from 0-4. A score of 0 indicates the lowest level of function and 4 indicating the highest level of function. Total scores range from 0-56, with higher scores indicating better balance.
Outcome measures
| Measure |
TPAD Treatment
n=11 Participants
All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.
TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
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Berg Balance Scale
Baseline
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48.00 units on a scale
Standard Deviation 5.45
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Berg Balance Scale
Day 5
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49.09 units on a scale
Standard Deviation 4.72
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Berg Balance Scale
Week 3
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49.18 units on a scale
Standard Deviation 4.69
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Adverse Events
TPAD Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sunil Agrawal, PhD
Columbia University Irving Medical Center
Phone: (212) 854-2841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place