NCT04978363

iWalk Hands Free Crutch

Effects of a Hands Free Crutch on Walking Stability During Gait

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to compare the hands free crutch (HFC) to standard axillary crutches (SACs) with and without a walking boot, using outcomes related to walking stability, balance confidence, patient preference, device comfort, and any reported pain while using the devices. Healthy, able-bodied individuals will wear a walking boot to simulate a below knee injury or post-surgery condition during participation. They will maintain a non-weight bearing status while completing the 4 research conditions in randomized order: 1) BOOT, 2) HFC + BOOT, 3) SAC + BOOT, or 4) NONE. Participants will complete 5 total sessions, with 4 biomechanics data collection sessions corresponding to the 4 conditions. At the first visit, participants will complete pre-consent screening and consent paperwork. Then they will be randomized to the 4 conditions above, and anthropometric (body height, weight/mass, leg length, shoe length and width) and demographic data will be collected. Participants will accommodate overnight to each of the 4 study conditions before testing. If participants are randomized to the NONE condition first, they will have the option of completing testing in that condition (no Boot) at the initial visit. The primary dependent measure is whole body angular momentum, an objective measure of walking stability. Data will be collected using over 50 small reflective markers placed on the participants and the assistive devices, a computerized motion capture system and force plates embedded in the floor. The force plates capture ground reaction forces which will be used to calculate joint moments for interpretation of angular momentum data. The motion capture system will be used to evaluate joint and segment kinematics and temporal-spatial data to characterize the gait pattern in each condition and calculate angular momentum. The second purpose of this research study is to determine the effect of crutch use on participant reported balance confidence and device preference. A validated balance confidence questionnaire and participant satisfaction, comfort and preference will be used to compare between conditions. A numerical pain rating scale (0-10) will be used to assess for any reported pain in all of the conditions. The third purpose of this research is to determine the effect of crutch (HFC and SACs) and boot (with and without) use on walking stability as measured by whole body and segmental angular momentum during gait. Two additional conditions are added to address this purpose (HFC NO BOOT and SAC NO BOOT), resulting in a total of 6 research conditions: 1\) BOOT, 2) HFC + BOOT, 3) SAC + BOOT 4) NONE, 5) HFC NO BOOT, 6) SAC NO BOOT The HFC NO BOOT condition will be evaluated at the end of the HFC + BOOT session, and the SAC NO BOOT condition will be evaluated at the end of the SAC + BOOT session to stay within the fiscal and logistical constraints of the project. Previously described methods will be used. Ultimately, this study could assist physical therapists and other providers in the clinical prescription and application of such devices.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2021-07-27
• Last updated: 2023-05-22
• Results posted: 2023-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study