HealthyNCT05120115
Optimization of Hip-exoskeleton Weight Attributes
A study testing Weight belt in people with Healthy and Gait, Frontal, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gait, Frontal
- What is being tested?
- Weight belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 6 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to commit to the full experimental session
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Gait, Frontal
- Being tested
- Weight belt
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight beltOther
Wearing belt around waist with various weights attached.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Weight belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Obliquity
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
Measured: One day
Secondary outcomes (2)
Knee Flexion Angle During Swing Phase
Knee flexion angle range of motion measured using optical motion capture
Measured: One Day
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start7 Oct 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120115
- Sponsor's protocol ID
- STUDY00001245
- Other IDs
- R01HD100416
- Status last verified
- Nov 2023
- First submitted
- 11 Jun 2021
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37004392
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Optimal Weight Design Parameters of a Hip Exoskeleton Designed for Rehabilitation.
- ClinicalTrials.gov ID
- NCT05120115
- Acronym / sponsor ID
- STUDY00001245
- Conditions
- Healthy, Gait, Frontal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight distribution and placement | Experimental | Other: Weight beltChanging 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing to commit to the full experimental session
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight beltWearing belt around waist with various weights attached. | Other | Weight distribution and placement |
Primary outcome
Pelvic Obliquity
Time frame: One day
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
2 secondary outcomes
Knee Flexion Angle During Swing Phase
Time frame: One Day
Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37004392Normand 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight belt in people with Healthy and Gait, Frontal, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Obliquity (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.