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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120115
Other study ID # STUDY00001245
Secondary ID R01HD100416
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date May 6, 2022

Study information

Verified date November 2023
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. They hypothesize that greater weight will have a greater effect on walking.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 6, 2022
Est. primary completion date May 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Weight belt
Wearing belt around waist with various weights attached.

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pelvic Obliquity Amount of pelvic obliquity in response to weighted belt measured using optical motion capture One day
Secondary Knee Flexion Angle During Swing Phase Knee flexion angle range of motion measured using optical motion capture One Day
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. One day
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