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

Status

Completed

Conditions

Intervention / Treatment

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

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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