- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120115
Optimization of Hip-exoskeleton Weight Attributes
November 6, 2023 updated by: University of Texas at Austin
Evaluating Optimal Weight Design Parameters of a Hip Exoskeleton Designed for Rehabilitation.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weight distribution and placement
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.
|
Wearing belt around waist with various weights attached.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic Obliquity
Time Frame: One day
|
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Flexion Angle During Swing Phase
Time Frame: One Day
|
Knee flexion angle range of motion measured using optical motion capture
|
One Day
|
|
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
Time Frame: One day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2021
Primary Completion (Actual)
May 6, 2022
Study Completion (Actual)
May 6, 2022
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001245
- R01HD100416 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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