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Completed

NCT Number: NCT05092932

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

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.

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Key information

Conditions

Healthy Adolescent Aged Gait Middle Age Physical Examination Young Adult

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N2Z4, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able bodied individuals self reported good health

Exclusion criteria

  • recent fractures history of neurologic disease or events.

Treatment and study plan

Normal Foot Force

Other

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.

Other names: Loadsol

Primary outcomes

  1. Force under the stance limb foot

    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.

    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).

Secondary outcomes

  1. Arm strength in newtons

    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.

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

  2. Perceived Exertion

    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.

    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.

  3. Walking aid preference

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

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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Normative Research of Walking Aid Selection in Normal Subjects

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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