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

Normative Research of Walking Aid Selection 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.

Study Overview

• Status: Completed
• Conditions: Adolescent; Healthy; Gait; Aged; Young Adult; Middle Age; Physical Examination
• Intervention / Treatment: Other: Normal Foot Force

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N2Z4
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Able bodied individuals self reported good health

Exclusion Criteria:

• recent fractures history of neurologic disease or events.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm strength in newtons	a hand held dynamometer will measure strength of the triceps, biceps, and latissimus Dorsi	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.
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.	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.
Walking aid preference	This is a one time assessment to determine which walking device is preferred after walking with all four devices.	Through study completion, an average of one day.

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Audrey R Zucker-Levin, PhD, The University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 28, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: gait; healthy; balance; muscle function; plantar force
• Other Study ID Numbers: NER32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No