HealthyHFCNCT04978363
iWalk Hands Free Crutch
A study testing BOOT, HFC and SAC in people with Healthy, run by University of Iowa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BOOT, HFC and SAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance and Clinical Outcomes Lab, The University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Effects of a Hands Free Crutch on Walking Stability During Gait
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.
Read the 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:
- 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.
- Conditions
- Healthy
- Being tested
- BOOT, HFC, SAC, HFC+BOOT, SAC+BOOT
- Keywords
- Hands Free Crutch, Crutches, Assistive devices, Balance, Walking stability, Gait analysis, Adult, Biomechanics, Walking boot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOOTDevice
Also called Walking Boot, CAM Boot, Controlled Ankle Motion Boot
A walking boot is a common type of brace/boot that restricts ankle and foot movement.
HFCDevice
Also called Hands Free Crutch, iWalk Free, iWalk 3.0
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.
SACDevice
Also called Standard Axillary Crutches, axillary crutches, crutches, underarm crutches
Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
HFC+BOOTDevice
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+BOOTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BOOT |
| 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. Receives: Device: HFC+BOOT |
| 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. Receives: Device: SAC+BOOT |
| 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. Receives: Device: HFC |
| Arm 6. SAC | Experimental | 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. Receives: Device: SAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one session (up to 2 hours long), out of 4 total sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start5 Oct 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all six testing conditions, including: 1. BOOT (walking boot) 2. HFC + BOOT (Hands Free Crutch with the walking boot) 3. SAC + BOOT (Standard Axillary Crutches with the walking boot) 4. NONE (no device/baseline) 5. HFC NO BOOT (Hands Free Crutch with no walking boot) and 6. 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- iWalkFree, Inc.
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa, Department of Physical Therapy and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978363
- Sponsor's protocol ID
- 202101408
- Acronym
- HFC
- Status last verified
- Apr 2023
- First submitted
- 18 Jul 2021
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hands Free Crutch on Walking Stability During Gait
- ClinicalTrials.gov ID
- NCT04978363
- Acronym / sponsor ID
- HFC / 202101408
- Conditions
- Healthy
- Keywords
- Hands Free Crutch, Crutches, Assistive devices, Balance, Walking stability, Gait analysis, Adult, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- iWalkFree, Inc.
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 22 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- All participants will complete all six testing conditions, including: 1. BOOT (walking boot) 2. HFC + BOOT (Hands Free Crutch with the walking boot) 3. SAC + BOOT (Standard Axillary Crutches with the walking boot) 4. NONE (no device/baseline) 5. HFC NO BOOT (Hands Free Crutch with no walking boot) and 6. 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1. NONE | No intervention | –Participants will be tested while wearing no boot and no assistive device. |
| Arm 2. BOOT | Experimental | Device: BOOTThe first intervention condition tested is a walking boot only on the subject's right lower extremity. |
| Arm 3. HFC+BOOT | Experimental | Device: HFC+BOOTThe second intervention condition tested is a Hands Free Crutch (HFC) with the walking boot, both worn on the subject's right lower extremity. |
| Arm 4. SAC+BOOT | Experimental | Device: SAC+BOOTThe 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. |
| Arm 5. HFC | Experimental | Device: HFCThe fourth intervention condition tested is the Hands Free Crutch worn on the subject's right lower extremity without the walking boot. |
| Arm 6. SAC | Experimental | Device: SACThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOOTAlso: Walking Boot, CAM Boot, Controlled Ankle Motion BootA walking boot is a common type of brace/boot that restricts ankle and foot movement. | Device | Arm 2. BOOT |
| HFCAlso: Hands Free Crutch, iWalk Free, iWalk 3.0The 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. | Device | Arm 5. HFC |
| SACAlso: Standard Axillary Crutches, axillary crutches, crutches, underarm crutchesStandard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries. | Device | Arm 6. SAC |
| HFC+BOOTThe 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. | Device | Arm 3. HFC+BOOT |
| SAC+BOOTStandard 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. | Device | Arm 4. SAC+BOOT |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M Wilken, PT, PhD principal investigator
University of Iowa, Department of Physical Therapy and Rehabilitation Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOOT, HFC and SAC in people with Healthy, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Body Angular Momentum-sagittal Plane (time frame: one session (up to 2 hours long), out of 4 total sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.