- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04978363
iWalk Hands Free Crutch (HFC)
Effects of a Hands Free Crutch on Walking Stability During Gait
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- Human Performance and Clinical Outcomes Lab, The University of Iowa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm 1. NONE
Participants will be tested while wearing no boot and no assistive device.
|
|
Experimental: Arm 2. BOOT
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
|
A walking boot is a common type of brace/boot that restricts ankle and foot movement.
Other Names:
|
Experimental: Arm 3. HFC+BOOT
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
|
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.
|
Experimental: Arm 4. SAC+BOOT
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.
|
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.
|
Experimental: Arm 5. HFC
The fourth intervention condition tested is the Hands Free Crutch worn on the subject's right lower extremity without the walking 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.
Other Names:
|
Experimental: Arm 6. SAC
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.
|
Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole Body Angular Momentum-sagittal Plane
Time Frame: one session (up to 2 hours long), out of 4 total sessions
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole Body Angular Momentum-transverse and frontal planes
Time Frame: Baseline
|
Range of whole-body angular momentum in the transverse and frontal planes during gait using the motion capture system.
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Baseline
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Segmental Angular Momentum-sagittal, transverse and frontal planes
Time Frame: Baseline
|
Range of segmental angular momentum will be compared in the sagittal, transverse and frontal planes during gait using the motion capture system.
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Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity-specific Balance Confidence (ABC) Scale
Time Frame: Baseline
|
Balance confidence will be assessed using the ABC Scale on 16 activities, using a 0-100% scale (0% = no confidence and 100% = completely confident).
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Baseline
|
Participant Device Comfort Score
Time Frame: Baseline
|
A modified device comfort scale using an 11-point rating overall score (0=Most Uncomfortable; 10=Most Comfortable).
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Baseline
|
Numerical Pain Rating Scale
Time Frame: over three sessions (an average of 2 hours for each session)
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Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
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over three sessions (an average of 2 hours for each session)
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Participant Device Numerical Score
Time Frame: over four sessions (an average of 2 hours for each session)
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A modified device comfort scale using an 11-point rating scale (0=worst assistive device;10=best assistive device).
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over four sessions (an average of 2 hours for each session)
|
Participant Device Preference
Time Frame: one session (up to 2 hours long), out of 4 total sessions
|
The participant will rank in order (1-4) their preference of assistive device: NONE, BOOT, HFC and SAC.
|
one session (up to 2 hours long), out of 4 total sessions
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa, Department of Physical Therapy and Rehabilitation Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202101408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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