Trial Outcomes & Findings for Optimization of Hip-exoskeleton Weight Attributes (NCT NCT05120115)
NCT ID: NCT05120115
Last Updated: 2023-11-29
Results Overview
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
One day
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Weight and Placement
Changing weights on belt at 0, 4, 6 and 8 kg (weight factor) and lumbar, bilateral or unilateral placement on pelvis (placement factor)
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
no Weight
|
21
|
|
Overall Study
4kg and Bilateral Weight Distribution
|
21
|
|
Overall Study
6kg and Bilateral Weight Distriubtion
|
21
|
|
Overall Study
8 kg and Bilateral Weight Distriubtion
|
21
|
|
Overall Study
4 kg and Lumbar Weight Distriubtion
|
21
|
|
Overall Study
6kg and Lumbar Weight Distriubtion
|
21
|
|
Overall Study
8 kg and Lumbar Weight Distribution
|
21
|
|
Overall Study
4kg and Unilateral Weight Distribution
|
21
|
|
Overall Study
6kg and Unilateral Weight Distribution
|
21
|
|
Overall Study
8kg and Unilateral Weight Distribution
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimization of Hip-exoskeleton Weight Attributes
Baseline characteristics by cohort
| Measure |
Weight and Placement
n=21 Participants
Changing where weight is distributed on belt around pelvis, specifically, bilaterally, 4th lumbar area, unilaterally on the left side. Also changing weight amounts at 4, 6 and 8 kg.
Weight belt: Wearing belt around waist with various weights attached.
|
|---|---|
|
Age, Continuous
|
26.7 Years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
height
|
172 cm
STANDARD_DEVIATION 7.58 • n=5 Participants
|
|
weight
|
65.9 kg
STANDARD_DEVIATION 8.53 • n=5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Healthy individuals
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
Outcome measures
| Measure |
Weight and Placement
n=21 Participants
Varying weight at 0, 4, 6 and 8 kg. Varying placement at bilateral, unilateral and lumbar areas of pelvis.
|
|---|---|
|
Pelvic Obliquity
No weight
|
-0.55 degrees
Standard Deviation 2.79
|
|
Pelvic Obliquity
4 kg and bilateral placement
|
-0.83 degrees
Standard Deviation 2.89
|
|
Pelvic Obliquity
6kg and unilateral weight distribution
|
-1.2 degrees
Standard Deviation 3.05
|
|
Pelvic Obliquity
8kg and unilateral weight distribution
|
-0.7 degrees
Standard Deviation 2.97
|
|
Pelvic Obliquity
4 kg and lumbar placement
|
-0.19 degrees
Standard Deviation 2.91
|
|
Pelvic Obliquity
6 kg and lumbar placement
|
0.08 degrees
Standard Deviation 2.93
|
|
Pelvic Obliquity
8kg and lumbar weight distribution
|
0.45 degrees
Standard Deviation 2.94
|
|
Pelvic Obliquity
4kg and unilateral
|
-0.76 degrees
Standard Deviation 2.98
|
|
Pelvic Obliquity
6kg and unilateral
|
-0.8 degrees
Standard Deviation 2.83
|
|
Pelvic Obliquity
8kg and unilateral
|
-1.15 degrees
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: One DayPopulation: Healthy Individuals
Knee flexion angle range of motion measured using optical motion capture
Outcome measures
| Measure |
Weight and Placement
n=21 Participants
Varying weight at 0, 4, 6 and 8 kg. Varying placement at bilateral, unilateral and lumbar areas of pelvis.
|
|---|---|
|
Knee Flexion Angle During Swing Phase
No weight
|
68.8 degrees
Standard Deviation 8.5
|
|
Knee Flexion Angle During Swing Phase
4 kg with bilateral
|
67.66 degrees
Standard Deviation 8.84
|
|
Knee Flexion Angle During Swing Phase
6 kg with bilateral
|
68.03 degrees
Standard Deviation 7.49
|
|
Knee Flexion Angle During Swing Phase
8 kg with bilateral
|
67.99 degrees
Standard Deviation 7.95
|
|
Knee Flexion Angle During Swing Phase
4 kg with lumbar
|
66 degrees
Standard Deviation 6.2
|
|
Knee Flexion Angle During Swing Phase
6kg with lumbar
|
66.13 degrees
Standard Deviation 7.01
|
|
Knee Flexion Angle During Swing Phase
8kg with lumbar
|
67.4 degrees
Standard Deviation 9.84
|
|
Knee Flexion Angle During Swing Phase
4kg with unilateral
|
68.41 degrees
Standard Deviation 8.09
|
|
Knee Flexion Angle During Swing Phase
6kg with unilateral
|
68.02 degrees
Standard Deviation 8.57
|
|
Knee Flexion Angle During Swing Phase
8kg with unilateral
|
66.23 degrees
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: One dayPopulation: Healthy Individuals
EMG signals were normalized via the mean-dynamic method (Burden and Bartlett, 1999), centering the EMG signal around 1. For data analysis, the EMG signal was integrated along each gait phase to calculate the integrated EMG (iEMG) values. For the gastrocnemius, we extrated the iEMG during the pre-swing phase only. The iEMG was normalized to average during walking, resulting in arbitrary units.
Outcome measures
| Measure |
Weight and Placement
n=21 Participants
Varying weight at 0, 4, 6 and 8 kg. Varying placement at bilateral, unilateral and lumbar areas of pelvis.
|
|---|---|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
No weight
|
1.16 arbitrary units
Standard Deviation 0.53
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
4 kg and bilateral
|
1.14 arbitrary units
Standard Deviation 0.48
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
6kg and bilateral
|
1.20 arbitrary units
Standard Deviation 0.55
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
8kg and bilateral
|
1.23 arbitrary units
Standard Deviation 0.53
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
4kg and lumbar
|
1.24 arbitrary units
Standard Deviation 0.66
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
6kg and lumbar
|
1.20 arbitrary units
Standard Deviation 0.54
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
8kg and lumbar
|
1.19 arbitrary units
Standard Deviation 0.56
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
4kg and unilateral
|
1.19 arbitrary units
Standard Deviation 0.49
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
6kg and unilateral
|
1.20 arbitrary units
Standard Deviation 0.51
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
8kg and unilateral
|
1.10 arbitrary units
Standard Deviation 0.43
|
Adverse Events
Weight and Placement
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place