CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
BOOT +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04978363
NCT04978363N/ACompleted

Effects of a Hands Free Crutch on Walking Stability During Gait

University of Iowa·interventional·Posted Jul 27, 2021·Updated May 22, 2023

In Brief

A clinical study evaluating BOOT, HFC, and 3 other interventions for Healthy. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsiWalkFree, Inc.

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 27, 2021
Enrollment StartOct 5, 2021
Primary CompletionJan 27, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.9 years ago

Interventions

BOOTdevice

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

HFCdevice

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.

SACdevice

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

HFC+BOOTdevice

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.

SAC+BOOTdevice

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.