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CompletedNCT05092932Updated May 9, 2024

Walking Aid Assessment, Arm Strength and Force Under the Foot in Normal Subjects

An observational study in Healthy, Physical Examination and Middle Age, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Saskatchewan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study summary

This study will collect biomedical performance data on walking characteristics in normal, healthy people when walking with walking aids and when walking unaided. Data will be used for independent reporting and for comparison to matched people with pathological conditions. Data collected will including walking ability, balance, force under the feet when walking and muscle strength.

Read the detailed description

Young adults often tolerate the increased energy expenditure, coordination, and stance limb discomfort associated with walking aids for non-weightbearing ambulation. It is not clear how walking aid selection affects stance limb plantar force, walking speed, perceived exertion, and device preference in adults over 50 years of age..

This project is a prospective randomized crossover study using healthy adults, aged over 50 years, with no use of walking aids within 5 years. Participants will walk 200 m under 4 randomized conditions: single non-weightbearing ambulation using crutches, a walker, a wheeled knee walker, and unaided walking. An in-shoe sensor will measure stance limb plantar force, a stopwatch will be used to time each walk, a hand held dynamometer will measure arm muscle strength, perceived exertion will be reported using the BORG CR-10 scale, and device preference will be identified.

02

Conditions studied

  • Healthy
  • Physical Examination
  • Middle Age
  • Aged
  • Young Adult
  • Adolescent
  • Gait

Keywords

  • healthy
  • gait
  • plantar force
  • balance
  • muscle function
03

In context

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

200 healthy adults who independently walk with or without an assistive device.

Inclusion criteria

  • Able bodied individuals self reported good health

Exclusion criteria

Exclusion Criteria:

  • recent fractures history of neurologic disease or events.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal Control Data

    Normal adults with no history of neuromusculoskeletal disease will be recruited for this study. Participants will be independent walkers (no walking aid needed) and will not have needed a walking aid for injury over the past 5 years. Participants will walk 200 m under 4 randomized conditions: non-weightbearing ambulation using crutches, a walker, a wheeled knee walker, and unaided walking. An in-shoe sensor will measure stance limb plantar force, a stopwatch will time each walk, perceived exertion will be reported using the BORG CR-10 scale, and device preference will be identified.

    Other: Normal Foot Force

Interventions

  • OtherNormal Foot Force

    LoadSol Insoles will be inserted into the participants shoes. The device measures the pressure distribution on the bottom of the foot. Participants will then be asked to walk normally, use crutches, use a walker, and use a wheeled knee scooter. The pressure placed throughout the foot will be analyzed and compared under different conditions. This testing will take approximately 10 minutes.

    Also known as: Loadsol

06

What researchers measure

Primary outcomes

  1. Force under the stance limb foot

    A wireless insole force sensor (LoadSol; Novel Inc) will be fitted in the shoe of the stance foot to measure stance limb plantar force during each walking trial. This force sensor covers the entire plantar surface of the foot and manufacturer's protocol for calibration will be applied for each participant before data is recorded at 100 Hz via Bluetooth connection to an iOS device (ie, an iPad).

    Time frame: Through study completion, an average of one day. This is a one time assessment comparing differences in the normal force under the foot when the participant walks under 4 walking conditions.

Secondary outcomes

  1. Arm strength in newtons

    a hand held dynamometer will measure strength of the triceps, biceps, and latissimus Dorsi

    Time frame: Through study completion an average of one day. This is a one time assessment to correlate strength with force under the stance limb foot with upper extremity strength under the 4 walking conditions.

  2. Perceived Exertion

    The BORG revised category-ratio scale. Participants will be asked to rate the exertion from 0 "nothing at all" to 10 "maximal" after walking with each walking aid.

    Time frame: Through study completion, an average of one day. This is a one time assessment to compare perceived exertion when the participant walks under 4 walking conditions.

  3. Walking aid preference

    This is a one time assessment to determine which walking device is preferred after walking with all four devices.

    Time frame: Through study completion, an average of one day.

07

Study locations

1 site
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N2Z4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05092932
Lead sponsor
University of Saskatchewan
Responsible party
Audrey Zucker-Levin (Professor, University of Saskatchewan) — Principal investigator
First posted
Oct 26, 2021
Start date
Jan 1, 2020
Primary completion
Oct 28, 2023
Completion
Dec 31, 2023
Last update
May 9, 2024

Study contacts

Audrey R Zucker-Levin, PhD
principal investigator · The University of Saskatchewan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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