Optimization of Hip-exoskeleton Weight Attributes

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120115
• Other study ID #: STUDY00001245
• Secondary ID: R01HD100416
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Frontal
• Healthy

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