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Optimization of Hip-exoskeleton Weight Attributes

Primary Purpose

Healthy, Gait, Frontal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight belt
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Walking Speed

Weight distribution

Weight amount

Arm Description

Changing speed of treadmill

Changing where weight is distributed on belt around pelvis, specifically, bilaterally, 4th lumbar area, unilaterally on the left side.

Changing the amount of weight used in belt around pelvis, 0 kg, 2 kg, 4 kg, and 6 kg.

Outcomes

Primary Outcome Measures

Pelvic range of motion
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture

Secondary Outcome Measures

Knee flexion angle during swing phase
Knee flexion angle measured using optical motion capture
Gastrocnemius muscle activity during preswing
Measured myographic muscle activity in gastrocnemius

Full Information

First Posted
June 11, 2021
Last Updated
November 2, 2021
Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05120115
Brief Title
Optimization of Hip-exoskeleton Weight Attributes
Official Title
Evaluating Optimal Weight Design Parameters of a Hip Exoskeleton Designed for Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are examining how weight distribution affects the way people walk, in terms of energy expenditure, 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 have three factors, weight location, amount of weight and walking speed. They are examining how these factors affect energy expenditure, muscle activation, joint motions and foot forces. The investigators plan to recruit 40 healthy adult individuals. Each of the 20 experimental conditions (2x3x3 factorial and two control conditions 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Gait, Frontal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking Speed
Arm Type
Experimental
Arm Description
Changing speed of treadmill
Arm Title
Weight distribution
Arm Type
Experimental
Arm Description
Changing where weight is distributed on belt around pelvis, specifically, bilaterally, 4th lumbar area, unilaterally on the left side.
Arm Title
Weight amount
Arm Type
Experimental
Arm Description
Changing the amount of weight used in belt around pelvis, 0 kg, 2 kg, 4 kg, and 6 kg.
Intervention Type
Other
Intervention Name(s)
Weight belt
Intervention Description
Wearing belt around waist with various weights attached.
Primary Outcome Measure Information:
Title
Pelvic range of motion
Description
Amount of pelvic obliquity in response to weighted belt measured using optical motion capture
Time Frame
One day
Secondary Outcome Measure Information:
Title
Knee flexion angle during swing phase
Description
Knee flexion angle measured using optical motion capture
Time Frame
One Day
Title
Gastrocnemius muscle activity during preswing
Description
Measured myographic muscle activity in gastrocnemius
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James S Sulzer, PhD
Phone
15125419036
Email
james.sulzer@utexas.edu
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James S Sulzer
Phone
512-541-9036
Email
james.sulzer@utexas.edu

12. IPD Sharing Statement

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Optimization of Hip-exoskeleton Weight Attributes

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