iWalk Hands Free Crutch

Summary

The proposed study evaluates the effects of a hands free crutch (iWalkFree, Inc.) on walking balance and stability compared to standard crutches. It is expected that the hands free crutch will provide better stability during walking on a level surface and better reported balance confidence compared to standard crutches. In this study, walking stability will be assessed using motion capture data from an infrared camera system with 12 mounted cameras surrounding a level walkway. Balance will be assessed through a self-reported activity-specific balance confidence (ABC) questionnaire. An improved understanding of the effects of the hands free crutch on gait may benefit the future prescription of ambulatory assistive devices. The proposed study may provide insight that can be used by physical therapists and other providers to select the ambulatory assistive device that best meets their patients' needs.

Conditions

• Healthy

Interventions

DEVICE

BOOT

A walking boot is a common type of brace/boot that restricts ankle and foot movement.

DEVICE

HFC

The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands.

DEVICE

SAC

Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.

DEVICE

HFC+BOOT

The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands. A walking boot is a common type of brace/boot that restricts ankle and foot movement.

DEVICE

SAC+BOOT

Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries. A walking boot is a common type of brace/boot that restricts ankle and foot movement.

Sponsors & Collaborators

• iWalkFree, Inc.

  collaborator INDUSTRY

• University of Iowa

  lead OTHER

Principal Investigators

• Jason M Wilken, PT, PhD · University of Iowa, Department of Physical Therapy and Rehabilitation Science

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-05

Primary Completion

2022-01-27

Completion

2022-01-27

FDA Device

Yes

Countries

• United States

Study Locations