Trial Outcomes & Findings for iWalk Hands Free Crutch (NCT NCT04978363)
NCT ID: NCT04978363
Last Updated: 2023-05-22
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
one session (up to 2 hours long), out of 4 total sessions
Results posted on
2023-05-22
Participant Flow
Participants were recruited by mass email and postings on a university news website between September 2021 and January 2022. The first participant was enrolled on October 5, 2021, and the last participant was enrolled on January 16, 2022.
One participant was enrolled in the study and then failed the post-screening. As a result they were excluded before assignment to the groups.
Participant milestones
| Measure |
NONE, HFC+BOOT, SAC+BOOT, BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, SAC+BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, SAC+BOOT, BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, HFC+BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, NONE, BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, BOOT, NONE, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, SAC+BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, HFC+BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, HFC+BOOT, NONE, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, BOOT, NONE, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, NONE, BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
1
|
3
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Overall Study
Discontinued Intervention
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
1
|
2
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NONE, HFC+BOOT, SAC+BOOT, BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, SAC+BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, SAC+BOOT, BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, HFC+BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, NONE, BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, BOOT, NONE, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, SAC+BOOT, HFC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, HFC+BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, HFC+BOOT, NONE, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, BOOT, NONE, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, NONE, BOOT, SAC+BOOT
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other medical issues unrelated to the study
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Unable to meet the necessary time commitment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Didn't feel safe and had pain with hands-free crutch
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
iWalk Hands Free Crutch
Baseline characteristics by cohort
| Measure |
NONE, HFC+BOOT, SAC+BOOT, BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, SAC+BOOT, HFC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, SAC+BOOT, BOOT, HFC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
NONE, BOOT, HFC+BOOT, SAC+BOOT
n=1 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, NONE, BOOT, HFC+BOOT
n=3 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
SAC+BOOT, BOOT, NONE, HFC+BOOT
n=1 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, SAC+BOOT, HFC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, NONE, HFC+BOOT, SAC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
BOOT, HFC+BOOT, NONE, SAC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, BOOT, NONE, SAC+BOOT
n=2 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
HFC+BOOT, NONE, BOOT, SAC+BOOT
n=1 Participants
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
1 Participants
n=19 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
19 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
27 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
41 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
27 years
STANDARD_DEVIATION 6.7 • n=31 Participants
|
27 years
STANDARD_DEVIATION 0.0 • n=30 Participants
|
32 years
STANDARD_DEVIATION 14.1 • n=3 Participants
|
23 years
STANDARD_DEVIATION 3.5 • n=6 Participants
|
21 years
STANDARD_DEVIATION 3.5 • n=114 Participants
|
32 years
STANDARD_DEVIATION 1.4
|
18 years
STANDARD_DEVIATION 0.0 • n=19 Participants
|
27 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
1 Participants
n=19 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one session (up to 2 hours long), out of 4 total sessionsPopulation: Healthy able-bodied individuals
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).
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
Arm 5. HFC
n=17 Participants
The fourth intervention condition tested is the Hands Free Crutch worn on the subject's right lower extremity without the walking boot.
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.
|
Arm 6. SAC
n=17 Participants
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Whole Body Angular Momentum-sagittal Plane
|
0.051 dimensionless
Standard Deviation 0.009
|
0.079 dimensionless
Standard Deviation 0.011
|
0.095 dimensionless
Standard Deviation 0.010
|
0.155 dimensionless
Standard Deviation 0.033
|
0.077 dimensionless
Standard Deviation 0.011
|
0.142 dimensionless
Standard Deviation 0.027
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Healthy able-bodied individuals completed the outcome measure for the arms listed above. They did not complete the outcome measure for HFC+Boot and SAC+Boot.
Balance confidence will be assessed using the ABC Scale on 16 activities, using a 0-100% scale (0% = no confidence and 100% = completely confident).
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
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.
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.
|
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Activity-specific Balance Confidence (ABC) Scale
|
98.75 score on a scale
Interval 95.94 to 100.0
|
87.50 score on a scale
Interval 77.5 to 93.13
|
57.50 score on a scale
Interval 45.94 to 70.31
|
58.82 score on a scale
Interval 44.69 to 72.81
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over three sessions (an average of 2 hours for each session)Population: Healthy able-bodied individuals completed the outcome measure for the arms listed above. They did not complete the outcome measure for HFC+Boot and SAC+Boot.
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
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.
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.
|
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Numerical Pain Rating Scale
|
0.00 units on a scale
Standard Deviation 0.00
|
1.12 units on a scale
Standard Deviation 1.76
|
2.59 units on a scale
Standard Deviation 1.73
|
2.47 units on a scale
Standard Deviation 1.91
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Healthy able-bodied individuals completed the outcome measure for the arms listed above. They did not complete the outcome measure for HFC+Boot and SAC+Boot.
A modified device comfort scale using an 11-point rating overall score (0=Most Uncomfortable; 10=Most Comfortable).
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
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.
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.
|
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Participant Device Comfort Score
|
9.76 score on a scale
Standard Deviation 0.44
|
7.82 score on a scale
Standard Deviation 1.13
|
5.00 score on a scale
Standard Deviation 2.62
|
5.12 score on a scale
Standard Deviation 2.09
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over four sessions (an average of 2 hours for each session)Population: Healthy able-bodied individuals completed the outcome measure for the arms listed above. They did not complete the outcome measure for HFC+Boot and SAC+Boot.
A modified device comfort scale using an 11-point rating scale (0=worst assistive device;10=best assistive device).
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
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.
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.
|
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Participant Device Numerical Score
|
9.06 score on a scale
Standard Deviation 1.60
|
8.00 score on a scale
Standard Deviation 1.37
|
6.35 score on a scale
Standard Deviation 2.83
|
5.94 score on a scale
Standard Deviation 1.95
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one session (up to 2 hours long), out of 4 total sessionsPopulation: Healthy able-bodied individuals completed the outcome measure for the arms listed above. They did not complete the outcome measure for HFC+Boot and SAC+Boot.
The participant will rank in order (1-4) their preference of assistive device: NONE, BOOT, HFC and SAC.
Outcome measures
| Measure |
Arm 1. NONE
n=17 Participants
Participants will be tested while wearing no boot and no assistive device.
|
Arm 2. BOOT
n=17 Participants
The first intervention condition tested is a walking boot only on the subject's right lower extremity.
BOOT: A walking boot is a common type of brace/boot that restricts ankle and foot movement.
|
Arm 3. HFC+BOOT
n=17 Participants
The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity.
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.
|
Arm 4. SAC+BOOT
n=17 Participants
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.
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.
|
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.
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.
|
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.
SAC: Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
|
|---|---|---|---|---|---|---|
|
Participant Device Preference
Preference 1
|
15 participants
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Participant Device Preference
Preference 2
|
0 participants
|
13 participants
|
3 participants
|
1 participants
|
—
|
—
|
|
Participant Device Preference
Preference 3
|
0 participants
|
2 participants
|
10 participants
|
5 participants
|
—
|
—
|
|
Participant Device Preference
Preference 4
|
2 participants
|
0 participants
|
4 participants
|
11 participants
|
—
|
—
|
Adverse Events
NONE, HFC+BOOT, SAC+BOOT, BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NONE, BOOT, SAC+BOOT, HFC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NONE, SAC+BOOT, BOOT, HFC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NONE, BOOT, HFC+BOOT, SAC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAC+BOOT, NONE, BOOT, HFC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAC+BOOT, BOOT, NONE, HFC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BOOT, NONE, SAC+BOOT, HFC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BOOT, NONE, HFC+BOOT, SAC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BOOT, HFC+BOOT, NONE, SAC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HFC+BOOT, BOOT, NONE, SAC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HFC+BOOT, NONE, BOOT, SAC+BOOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place