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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD100416 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight distribution and placement | Experimental | Changing where weight is distributed on belt around pelvis, specifically, bilaterally, 4th lumbar area, unilaterally on the left side. Also changing amount of weight at 0, 4, 6 and 8 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight belt | Other | Wearing belt around waist with various weights attached. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Obliquity | Amount of pelvic obliquity in response to weighted belt measured using optical motion capture | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Flexion Angle During Swing Phase | Knee flexion angle range of motion measured using optical motion capture | One Day |
| Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking |
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Inclusion Criteria:
Exclusion Criteria:
Functionally relevant lower limb musculoskeletal injury
Patients with cardiac issues may be included, but the cardiac issue will be noted in the health history questionnaire
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37004392 | Derived | Normand MA, Lee J, Su H, Sulzer JS. The effect of hip exoskeleton weight on kinematics, kinetics, and electromyography during human walking. J Biomech. 2023 May;152:111552. doi: 10.1016/j.jbiomech.2023.111552. Epub 2023 Mar 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Healthy individuals
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pelvic Obliquity | Amount of pelvic obliquity in response to weighted belt measured using optical motion capture | Healthy individuals | Posted | Mean | Standard Deviation | degrees | One day |
|
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1 day
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Sulzer | MetroHealth Hospital | 5125419036 | jss280@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2021 | Jul 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2021 | Jul 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| One day |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| height | Mean | Standard Deviation | cm |
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| weight | Mean | Standard Deviation | kg |
|
|
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| Secondary | Knee Flexion Angle During Swing Phase | Knee flexion angle range of motion measured using optical motion capture | Healthy Individuals | Posted | Mean | Standard Deviation | degrees | One Day |
|
|
|
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| 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. | Healthy Individuals | Posted | Mean | Standard Deviation | arbitrary units | One day |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| Title | Measurements |
|---|---|
|
| 8 kg with bilateral |
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| 4 kg with lumbar |
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| 6kg with lumbar |
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| 8kg with lumbar |
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| 4kg with unilateral |
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| 6kg with unilateral |
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| 8kg with unilateral |
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| Title | Measurements |
|---|---|
|
| 8kg and bilateral |
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| 4kg and lumbar |
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| 6kg and lumbar |
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| 8kg and lumbar |
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| 4kg and unilateral |
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| 6kg and unilateral |
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| 8kg and unilateral |
|