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Optimization of Hip-exoskeleton Weight Attributes

Evaluating Optimal Weight Design Parameters of a Hip Exoskeleton Designed for Rehabilitation.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05120115
Enrollment
21
Registered
2021-11-15
Start date
2021-10-07
Completion date
2022-05-06
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Frontal, Healthy

Brief summary

The investigators are examining how weight distribution affects the way people walk, in terms of joint kinematics, kinetics, and muscle activity. The investigators are measuring these quantities while people walk while wearing a weighted belt. The investigators distribute the weights and walk for specified periods. They hypothesize that greater weight will have a greater effect on walking.

Detailed description

The purpose of this study is to examine how the amount and distribution of weight on the pelvis affects how people walk. The investigators two factors, weight and placement. They are examining how these factors affect muscle activation, joint motions and foot forces. The investigators plan to recruit 40 healthy adult individuals. Each of the 20 experimental conditions (3x3 factorial and one control condition with no weight) will be recorded immediately in a single session. The investigators hypothesize that weight amount, gait speed and weight distribution will all affect how people walk, which will lead towards optimized design of hip exoskeletons.

Interventions

OTHERWeight belt

Wearing belt around waist with various weights attached.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Willing to commit to the full experimental session

Exclusion criteria

* Functionally relevant lower limb musculoskeletal injury * Functionally relevant osteoarthritis and weight bearing restrictions * Severe respiratory problems that restrict the wearer from using a metabolic rate apparatus * Patients with cardiac issues may be included, but the cardiac issue will be noted in the health history questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Pelvic ObliquityOne dayAmount of pelvic obliquity in response to weighted belt measured using optical motion capture

Secondary

MeasureTime frameDescription
Knee Flexion Angle During Swing PhaseOne DayKnee flexion angle range of motion measured using optical motion capture
Integrated Gastrocnemius Muscle Activity During Preswing Phase of WalkingOne dayEMG 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Weight and Placement
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.
21
Total21

Baseline characteristics

CharacteristicWeight and Placement
Age, Continuous26.7 Years
STANDARD_DEVIATION 5.75
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
height172 cm
STANDARD_DEVIATION 7.58
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
15 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
12 Participants
weight65.9 kg
STANDARD_DEVIATION 8.53

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 21
other
Total, other adverse events
0 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

Primary

Pelvic Obliquity

Amount of pelvic obliquity in response to weighted belt measured using optical motion capture

Time frame: One day

Population: Healthy individuals

ArmMeasureGroupValue (MEAN)Dispersion
Weight and PlacementPelvic ObliquityNo weight-0.55 degreesStandard Deviation 2.79
Weight and PlacementPelvic Obliquity4 kg and bilateral placement-0.83 degreesStandard Deviation 2.89
Weight and PlacementPelvic Obliquity6kg and unilateral weight distribution-1.2 degreesStandard Deviation 3.05
Weight and PlacementPelvic Obliquity8kg and unilateral weight distribution-0.7 degreesStandard Deviation 2.97
Weight and PlacementPelvic Obliquity4 kg and lumbar placement-0.19 degreesStandard Deviation 2.91
Weight and PlacementPelvic Obliquity6 kg and lumbar placement0.08 degreesStandard Deviation 2.93
Weight and PlacementPelvic Obliquity8kg and lumbar weight distribution0.45 degreesStandard Deviation 2.94
Weight and PlacementPelvic Obliquity4kg and unilateral-0.76 degreesStandard Deviation 2.98
Weight and PlacementPelvic Obliquity6kg and unilateral-0.8 degreesStandard Deviation 2.83
Weight and PlacementPelvic Obliquity8kg and unilateral-1.15 degreesStandard Deviation 2.77
p-value: 0.05ANOVA
Secondary

Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking

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.

Time frame: One day

Population: Healthy Individuals

ArmMeasureGroupValue (MEAN)Dispersion
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of WalkingNo weight1.16 arbitrary unitsStandard Deviation 0.53
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking4 kg and bilateral1.14 arbitrary unitsStandard Deviation 0.48
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking6kg and bilateral1.20 arbitrary unitsStandard Deviation 0.55
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking8kg and bilateral1.23 arbitrary unitsStandard Deviation 0.53
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking4kg and lumbar1.24 arbitrary unitsStandard Deviation 0.66
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking6kg and lumbar1.20 arbitrary unitsStandard Deviation 0.54
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking8kg and lumbar1.19 arbitrary unitsStandard Deviation 0.56
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking4kg and unilateral1.19 arbitrary unitsStandard Deviation 0.49
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking6kg and unilateral1.20 arbitrary unitsStandard Deviation 0.51
Weight and PlacementIntegrated Gastrocnemius Muscle Activity During Preswing Phase of Walking8kg and unilateral1.10 arbitrary unitsStandard Deviation 0.43
p-value: 0.05Mixed Models Analysis
Secondary

Knee Flexion Angle During Swing Phase

Knee flexion angle range of motion measured using optical motion capture

Time frame: One Day

Population: Healthy Individuals

ArmMeasureGroupValue (MEAN)Dispersion
Weight and PlacementKnee Flexion Angle During Swing PhaseNo weight68.8 degreesStandard Deviation 8.5
Weight and PlacementKnee Flexion Angle During Swing Phase4 kg with bilateral67.66 degreesStandard Deviation 8.84
Weight and PlacementKnee Flexion Angle During Swing Phase6 kg with bilateral68.03 degreesStandard Deviation 7.49
Weight and PlacementKnee Flexion Angle During Swing Phase8 kg with bilateral67.99 degreesStandard Deviation 7.95
Weight and PlacementKnee Flexion Angle During Swing Phase4 kg with lumbar66 degreesStandard Deviation 6.2
Weight and PlacementKnee Flexion Angle During Swing Phase6kg with lumbar66.13 degreesStandard Deviation 7.01
Weight and PlacementKnee Flexion Angle During Swing Phase8kg with lumbar67.4 degreesStandard Deviation 9.84
Weight and PlacementKnee Flexion Angle During Swing Phase4kg with unilateral68.41 degreesStandard Deviation 8.09
Weight and PlacementKnee Flexion Angle During Swing Phase6kg with unilateral68.02 degreesStandard Deviation 8.57
Weight and PlacementKnee Flexion Angle During Swing Phase8kg with unilateral66.23 degreesStandard Deviation 6.72
p-value: 0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026