iWalk Hands Free Crutch
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): BOOT; HFC; SAC; HFC+BOOT; SAC+BOOT
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): A walking boot is a common type of brace/boot that restricts ankle and foot movement.; 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.; Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.; 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.; 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.
Other intervention name(s): Walking Boot; CAM Boot; Controlled Ankle Motion Boot; Hands Free Crutch; iWalk Free; iWalk 3.0; Standard Axillary Crutches; axillary crutches; crutches; underarm crutches
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will complete all six testing conditions, including:
BOOT (walking boot)
HFC + BOOT (Hands Free Crutch with the walking boot)
SAC + BOOT (Standard Axillary Crutches with the walking boot)
NONE (no device/baseline)
HFC NO BOOT (Hands Free Crutch with no walking boot) and
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.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hands Free Crutch; Crutches; Assistive devices; Balance; Walking stability; Gait analysis; Adult; Biomechanics; Walking boot