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The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.
Healthy adult individuals will be invited to participate in this study, at the University of Iowa, that involves one visit lasting 3-4 hours. The primary purpose of this work is to determine the effects of Malleo-Lok stiffness on gait biomechanics and ankle joint stiffness. Previous work has highlighted the effects of ankle foot orthosis stiffness on gait using devices with a traditional single posterior strut opposed to the Malleo-Lok, which has two laterally positioned struts. Orthosis stiffness is an important factor to consider during device prescription and manufacturing. The ability to tune overall joint level stiffness by determining the combined effects of biological limb stiffness and orthosis stiffness will enhance precision medicine when treating individuals who require an orthosis for daily activities. The secondary purpose of this research study is to determine the within session repeatability of a novel approach for in-vivo AFO stiffness testing. AFO stiffness testing is typically performed using mechanical testing systems without accounting for the interaction of the individual and the device.
During the visit to the University of Iowa campus participants will review a list of inclusion and exclusion criteria to determine their eligibility for this study. Eligible participants will review an informed consent document and have the chance to ask any questions they may have. Study staff will thoroughly explain the informed consent document and answer all questions. Upon signing the informed consent document study activities will begin. Participants will complete all study activities wearing no brace and two braces of differing stiffness's. Anthropometric and demographic information will be collected from each participant. The investigators will also use a motion capture system to evaluate gait biomechanics and ankle joint stiffness. Participants will walk at a self-selected and a controlled speed to evaluate gait biomechanics, and will stand in the motion capture system and bring their knee forward over the foot to evaluate ankle joint stiffness. Participants will be provided visual feedback of muscle activity to minimize lower limb muscle activity during ankle stiffness testing.
Results from the proposed study will provide information about the effects of orthosis stiffness on gait biomechanics and ankle joint stiffness. Study results will be made available to clinicians to use when prescribing and fitting individuals with ankle foot orthoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compliant, NoCDO, Stiff | Experimental | Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff). |
|
| Compliant, Stiff, NoCDO | Experimental | Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO). |
|
| NoCDO, Compliant, Stiff | Experimental | Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff). |
|
| NoCDO, Stiff, Compliant | Experimental | Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant). |
|
| Stiff, Compliant, NoCDO | Experimental | Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malleo-Lok | Device | The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Joint Stiffness | Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree). | In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes). |
| Ankle Joint Power | Peak ankle joint push-off power (W/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes). |
| Ankle Joint Moment | Peak ankle plantarflexion moment (Nm/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale | Participants were asked to rate their pain on a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain after completing testing in no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | Participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | Baseline |
| Center of Pressure Velocity Timing | Timing of peak center of pressure velocity (percent stance) during gait. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason M Wilken, PT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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All participants completed study activities in each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Compliant, NoCDO, Stiff | Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff). |
| FG001 | Compliant, Stiff, NoCDO | Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO). |
| FG002 | NoCDO, Compliant, Stiff | Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff). |
| FG003 | NoCDO, Stiff, Compliant | Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant). |
| FG004 | Stiff, Compliant, NoCDO | Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO). |
| FG005 | Stiff, NoCDO, Compliant | Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants completed study activities in each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.
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| ID | Title | Description |
|---|---|---|
| BG000 | Compliant, NoCDO, Stiff | Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff). |
| BG001 | Compliant, Stiff, NoCDO |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Ankle Joint Stiffness | Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree). | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. | Posted | Mean | Standard Deviation | Nm/degree | In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes). |
|
Study participants were asked to indicate any adverse events throughout the duration of the study visit. After completion of the study visit participants were also asked to call or email the research team if any adverse events related to the study occurred after the study visit (up to ~12 months after the visit).
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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 | NoCDO | Participants will be tested while wearing no brace (NoCDO) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason M Wilken, PT, PhD | The University of Iowa | 319-335-6857 | jason-wilken@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 | Apr 11, 2023 | Apr 11, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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All participants will be tested wearing no brace and two braces of differing stiffness's. The testing order will be randomized for each participant to prevent testing order from influencing study results.
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Participants will be blinded to the stiffness of each brace. Braces will be labeled A and B, with stiffness only known by research staff.
|
| Stiff, NoCDO, Compliant | Experimental | Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant). |
|
|
| Modified Socket Comfort Score: Comfort | Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the comfort of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | Participants were asked to rate their comfort after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions. |
| Modified Socket Comfort Score: Smoothness | Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the smoothness of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions. |
| Baseline |
| Soleus Muscle Activity (Electromyography) | Electromyography of soleus activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Baseline |
| Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography of medial gastrocnemius activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Baseline |
| Tibialis Anterior Muscle Activity (Electromyography) | Electromyography of tibialis anterior activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Baseline |
| Peroneus Longus Muscle Activity (Electromyography) | Electromyography of peroneus longus activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Baseline |
Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).
| BG002 | NoCDO, Compliant, Stiff | Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff). |
| BG003 | NoCDO, Stiff, Compliant | Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant). |
| BG004 | Stiff, Compliant, NoCDO | Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO). |
| BG005 | Stiff, NoCDO, Compliant | Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant). |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Compliant | Participants will be tested while wearing a moderate stiffness orthosis (Compliant) |
| OG002 | Stiff | Participants will be tested while wearing a stiff orthosis (Stiff). |
|
|
| Primary | Ankle Joint Power | Peak ankle joint push-off power (W/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. | Posted | Mean | Standard Deviation | W/kg | Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes). |
|
|
|
| Primary | Ankle Joint Moment | Peak ankle plantarflexion moment (Nm/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. | Posted | Mean | Standard Deviation | Nm/kg | Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes). |
|
|
|
| Secondary | Numerical Pain Rating Scale | Participants were asked to rate their pain on a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain after completing testing in no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. | Posted | Mean | Standard Deviation | score on a scale | Participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions. |
|
|
|
| Secondary | Modified Socket Comfort Score: Comfort | Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the comfort of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. The modified socket comfort score does not apply to walking without an orthosis, so was not assessed for the NoCDO condition. | Posted | Mean | Standard Deviation | score on a scale | Participants were asked to rate their comfort after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions. |
|
|
|
| Secondary | Modified Socket Comfort Score: Smoothness | Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the smoothness of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. | All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. The modified socket comfort score does not apply to walking without an orthosis, so was not assessed for the NoCDO condition. | Posted | Mean | Standard Deviation | score on a scale | Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions. |
|
|
|
| Other Pre-specified | Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Center of Pressure Velocity Timing | Timing of peak center of pressure velocity (percent stance) during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Soleus Muscle Activity (Electromyography) | Electromyography of soleus activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Not Posted | Baseline | Participants |
| Other Pre-specified | Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography of medial gastrocnemius activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Not Posted | Baseline | Participants |
| Other Pre-specified | Tibialis Anterior Muscle Activity (Electromyography) | Electromyography of tibialis anterior activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Not Posted | Baseline | Participants |
| Other Pre-specified | Peroneus Longus Muscle Activity (Electromyography) | Electromyography of peroneus longus activity during in-vivo ankle stiffness testing was used as visual feedback for participants during testing. | Not Posted | Baseline | Participants |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Compliant | Participants will be tested while wearing a moderate stiffness orthosis (Compliant). | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Stiff | Participants will be tested while wearing a stiff orthosis (Stiff) | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |