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| Name | Class |
|---|---|
| iWalkFree, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1. NONE | No Intervention | Participants will be tested while wearing no boot and no assistive device. | |
| Arm 2. BOOT | Experimental | The first intervention condition tested is a walking boot only on the subject's right lower extremity. |
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| Arm 3. HFC+BOOT | Experimental | The second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity. |
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| Arm 4. SAC+BOOT | Experimental | 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. |
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| Arm 5. HFC | Experimental | The fourth intervention condition tested is the Hands Free Crutch worn on the subject's right lower extremity without the walking boot. |
|
| Arm 6. SAC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOOT | Device | A walking boot is a common type of brace/boot that restricts ankle and foot movement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole Body Angular Momentum-sagittal Plane | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Activity-specific Balance Confidence (ABC) Scale | Balance confidence will be assessed using the ABC Scale on 16 activities, using a 0-100% scale (0% = no confidence and 100% = completely confident). | Baseline |
| Numerical Pain Rating Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason M Wilken, PT, PhD | University of Iowa, Department of Physical Therapy and Rehabilitation Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Performance and Clinical Outcomes Lab, The University of Iowa | Iowa City | Iowa | 52242 | United States |
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One participant was enrolled in the study and then failed the post-screening. As a result they were excluded before assignment to the groups.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | NONE, BOOT, SAC+BOOT, HFC+BOOT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole Body Angular Momentum-sagittal Plane | 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). | Healthy able-bodied individuals | Posted | Mean | Standard Deviation | dimensionless | one session (up to 2 hours long), out of 4 total sessions |
|
Each participant was assessed an average of one week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly Pacha | University of Iowa | 319-290-7596 | molly-pacha@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2021 | Apr 17, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003446 | Crutches |
| ID | Term |
|---|---|
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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All participants will complete all six testing conditions, including:
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.
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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. |
|
| HFC | Device | 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. |
|
|
| SAC | Device | Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries. |
|
|
| HFC+BOOT | Device | 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. |
|
| SAC+BOOT | Device | 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. |
|
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
| over three sessions (an average of 2 hours for each session) |
| Participant Device Comfort Score | A modified device comfort scale using an 11-point rating overall score (0=Most Uncomfortable; 10=Most Comfortable). | Baseline |
| Participant Device Numerical Score | A modified device comfort scale using an 11-point rating scale (0=worst assistive device;10=best assistive device). | over four sessions (an average of 2 hours for each session) |
| Participant Device Preference | 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 |
| Unable to meet the necessary time commitment |
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| Didn't feel safe and had pain with hands-free crutch |
|
The testing order of each of four primary conditions (BOOT, HFC + BOOT, SAC + BOOT, or NONE) will be randomized for each participant.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | 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. |
| BG010 | 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. |
| BG011 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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. 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. |
| OG003 | 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. 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| Other Pre-specified | Activity-specific Balance Confidence (ABC) Scale | Balance confidence will be assessed using the ABC Scale on 16 activities, using a 0-100% scale (0% = no confidence and 100% = completely confident). | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Numerical Pain Rating Scale | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | over three sessions (an average of 2 hours for each session) |
|
|
|
| Other Pre-specified | Participant Device Comfort Score | A modified device comfort scale using an 11-point rating overall score (0=Most Uncomfortable; 10=Most Comfortable). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Participant Device Numerical Score | A modified device comfort scale using an 11-point rating scale (0=worst assistive device;10=best assistive device). | 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. | Posted | Mean | Standard Deviation | score on a scale | over four sessions (an average of 2 hours for each session) |
|
|
|
| Other Pre-specified | Participant Device Preference | The participant will rank in order (1-4) their preference of assistive device: NONE, BOOT, HFC and SAC. | 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. | Posted | Number | participants | one session (up to 2 hours long), out of 4 total sessions |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG004 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG007 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG008 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG009 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG010 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| Preference 2 |
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| Preference 3 |
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| Preference 4 |
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