N/A
N=20
iWalk Hands Free Crutch
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04978363 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Whole Body Angular Momentum-sagittal Plane — 0.051; 0.079; 0.095; 0.155 dimensionless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BOOT (Device); HFC (Device); SAC (Device); HFC+BOOT (Device); SAC+BOOT (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Body Angular Momentum-sagittal Plane |
0.051; 0.079; 0.095; 0.155; 0.077; 0.142 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04978363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.