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

NCT05092932 | Completed

• 1 other identifier: NER32
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

healthy; gait; plantar force; balance; muscle function

Outcome Measures

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).

  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 (3)

• 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.

• 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.

• Walking aid preference

  Through study completion, an average of one day.

Study Arms (1)

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

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.

Also known as: Loadsol

Normal Control Data

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Able bodied individuals self reported good health

You may not qualify if:

• recent fractures history of neurologic disease or events.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N2Z4, Canada

Location

Study Officials

• Audrey R Zucker-Levin, PhD

  The University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: October 26, 2021
• Study Start: January 1, 2020
• Primary Completion: October 28, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CA (1)