iWalk Hands Free Crutch

NCT04978363 | Completed Results FDA Device

• 1 other identifier: 202101408
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hands Free Crutch; Crutches; Assistive devices; Balance; Walking stability; Gait analysis; Adult; Biomechanics; Walking boot

Outcome Measures

Primary Outcomes (1)

• Whole Body Angular Momentum-sagittal Plane

  Range of whole-body angular momentum in the sagittal plane during gait using the motion capture system. While angular momentum can be measured in kg\*m\^2/second it is reported as dimensionless in this study as it has been normalized to body weight (kg), height (m), and walking speed (m/s).

  one session (up to 2 hours long), out of 4 total sessions

Other Outcomes (5)

• Activity-specific Balance Confidence (ABC) Scale

  Baseline

• Numerical Pain Rating Scale

  over three sessions (an average of 2 hours for each session)

• Participant Device Comfort Score

  Baseline

Study Arms (6)

Arm 1. NONE

NO INTERVENTION

Participants will be tested while wearing no boot and no assistive device.

Arm 2. BOOT

EXPERIMENTAL

The first intervention condition tested is a walking boot only on the subject's right lower extremity.

Device: BOOT

Arm 3. HFC+BOOT

EXPERIMENTAL

The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.

Device: HFC+BOOT

Arm 4. SAC+BOOT

EXPERIMENTAL

The third intervention condition tested is standard axillary crutches (SAC) with the walking boot worn in non-weight bearing on the subject's right lower extremity.

Device: SAC+BOOT

Arm 5. HFC

EXPERIMENTAL

The fourth intervention condition tested is the Hands Free Crutch worn on the subject's right lower extremity without the walking boot.

Device: HFC

Arm 6. SAC

EXPERIMENTAL

The fifth and last intervention condition tested is standard axillary crutches with the subject non-weight bearing on the right lower extremity without the walking boot.

Device: SAC

Interventions

BOOT DEVICE

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

Also known as: Walking Boot, CAM Boot, Controlled Ankle Motion Boot

Arm 2. BOOT

HFC DEVICE

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.

Also known as: Hands Free Crutch, iWalk Free, iWalk 3.0

Arm 5. HFC

SAC DEVICE

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

Also known as: Standard Axillary Crutches, axillary crutches, crutches, underarm crutches

Arm 6. SAC

HFC+BOOT DEVICE

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.

Arm 3. HFC+BOOT

SAC+BOOT DEVICE

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.

Arm 4. SAC+BOOT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female
• Ages: 18 - 45
• Height between 5'2" and 6'6"
• Foot size that corresponds to available walking boots
• Healthy individuals without current complaint of lower extremity pain, spine pain, open wounds or active infection
• Full active pain free range of motion of the bilateral upper and lower extremities and spine
• Able to hop without pain
• Able to perform a full squat without pain
• Able to walk up and down a flight of stairs at normal walking speed without using the hand rail
• Able to stand on one leg for at least 30 seconds
• Able to read and write in English and provide written informed consent

You may not qualify if:

• Weight greater than 270 lbs
• BMI greater than 35
• Maximum thigh circumference at top of the leg greater than 28"
• Prior medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
• Prior lower extremity injury proximal to the ankle requiring surgery or limiting function for greater than 6 weeks
• Prior back pain that recurs or has limited activities for greater than 6 weeks
• Diagnosed moderate or severe brain injury
• Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
• Uncorrected visual or hearing impairment(s)
• Require use of an assistive device
• Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study

Sponsors & Collaborators

• University of Iowa: lead
• iWalkFree, Inc.: collaborator

Study Sites (1)

Human Performance and Clinical Outcomes Lab, The University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Crutches

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Molly Pacha
• Organization: University of Iowa

molly-pacha@uiowa.edu

319-290-7596

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa, Department of Physical Therapy and Rehabilitation Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy and Rehabilitation Science

Model Details: All participants will complete all six testing conditions, including: 1. BOOT (walking boot) 2. HFC + BOOT (Hands Free Crutch with the walking boot) 3. SAC + BOOT (Standard Axillary Crutches with the walking boot) 4. NONE (no device/baseline) 5. HFC NO BOOT (Hands Free Crutch with no walking boot) and 6. SAC NO BOOT (Standard Axillary Crutches with no walking boot). The order of the four primary conditions will be randomized using an online random number generator (1-4) with: 1=NONE, 2=BOOT only, 3=HFC+BOOT, and 4=SAC+BOOT.

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 27, 2021
• Study Start: October 5, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: May 22, 2023
• Results First Posted: May 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)