NCT05120115

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 29, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 11, 2021

Results QC Date

July 28, 2023

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pelvic Obliquity

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

    One day

Secondary Outcomes (2)

  • Knee Flexion Angle During Swing Phase

    One Day

  • Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking

    One day

Study Arms (1)

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.

Other: Weight belt

Interventions

Wearing belt around waist with various weights attached.

Weight distribution and placement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to commit to the full experimental session

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
James Sulzer
Organization
MetroHealth Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

November 15, 2021

Study Start

October 7, 2021

Primary Completion

May 6, 2022

Study Completion

May 6, 2022

Last Updated

November 29, 2023

Results First Posted

November 29, 2023

Record last verified: 2023-11

Locations