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

Healthy Clinical Trial

Official title:

Normative Research of Walking Aid Selection in Normal Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092932
• Other study ID #: NER32
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Saskatchewan
• Contact: Audrey R Zucker-Levin, PhD
• Phone: 13069667838
• Email: audrey.zuckerlevin[@]usask.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: October 28, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Able bodied individuals self reported good health

Exclusion Criteria:

• recent fractures history of neurologic disease or events.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.