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

Completed

• Conditions: Physical Examination; Young Adult; Middle Age; Aged; Adolescent; Gait; Healthy
• Interventions: Other: Normal Foot Force

• Registration Number: NCT05092932
• Lead Sponsor: University of Saskatchewan

Brief 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.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-26
• Primary Completion: 2023-10-28
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Able bodied individuals self reported good health

Exclusion Criteria

• recent fractures history of neurologic disease or events.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Control Data	Normal Foot Force	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.

Primary Outcome Measures

Name	Time	Method
Force under the stance limb foot	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 Outcome Measures

Name	Time	Method
Arm strength in newtons	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
Perceived Exertion	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.
Walking aid preference	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.

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada