Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.
Syme's prostheses are typically limited to low-profile prosthetic feet due to clearance restrictions below the prosthetic socket. As a result, the functional benefits provided by the long residual limb are mitigated by prosthetic design limitations. Recently, high-profile, posteriorly-attaching crossover feet have been modified for use with people who have Syme's amputation. Crossover feet theoretically improve motion and energy storage-and-return compared to traditional foot options for the Syme's level. Crossover feet also have the potential to broaden the range of high-impact activities that can be performed with a single prosthesis. However, to date there is no empirical evidence that compares functional differences when walking with high-profile crossover feet compared to low-profile feet for people with Syme's amputation. This mixed-method pilot research will use a randomized, controlled within-participants design. Investigators will assess gait biomechanics, self-reported health outcomes, and qualitative interviews to compare relative advantages and disadvantages of traditional low-profile Syme's feet and high-profile crossover feet. This proposed work will create a foundation for future research that examines the potential benefits of crossover feet in people with Syme's amputation. In addition, results from this research will be used clinically to inform prosthetic options for people with limited clearance for distally-attached prosthetic feet.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Experimental | Participant randomized to crossover foot as first condition, energy storing foot as second condition |
|
| Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Experimental | Participant randomized to energy storing foot as first condition, crossover foot as second condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crossover foot | Device | A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio Between Sound and Prosthetic Side Step Lengths | The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot. | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Total Prosthetic Ankle Range of Motion | The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion & plantarflexion) during stance phase between prosthetic feet, in degrees | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Prosthetic-side Energy Return | Intersegmental flow of power out of the prosthesis | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Peak Sound-side Limb Loading | Maximum vertical ground reaction force in early stance | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Measure | Description | Time Frame |
|---|---|---|
| Preference Questionnaire | At the end of the study, participants will engage in a preference questionnaire with open-ended follow-up questions to elicit preferences and experiences with both feet. Questions will ask about overall preference, and preference for a range of mobility activities (e.g., "Which foot did you prefer overall, and why?" and "Which foot did you prefer for walking up stairs, and why?"). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sara Morgan, PhD, CPO | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Amplifying Mobility and Performance Laboratory | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870369 | Derived | Slater C, Hafner BJ, Morgan SJ. Effects of high-profile crossover feet on gait biomechanics in 2 individuals with Syme amputation. Prosthet Orthot Int. 2024 Oct 1;48(5):510-518. doi: 10.1097/PXR.0000000000000295. Epub 2023 Oct 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Participants first received a crossover foot, then switched to an energy storing foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection & subsequent switch. |
| FG001 | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Participants first received an energy storing foot, then switched to a crossover foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection & subsequent switch. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Foot 1 (Two Week Utilization) |
|
| ||||||||||||||||||
| Foot 2 (Two Week Utilization) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Participants first received a crossover foot, then switched to an energy storing foot |
| BG001 | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Ratio Between Sound and Prosthetic Side Step Lengths | The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot. | Posted | Number | Sound step length / Pros. step length | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
Through study completion, an average of 1 year
At each research session, a Physical Health questionnaire was administered in which participants reported other non-serious adverse events relevant to the study, including residual limb sores, phantom pain, and loss of sensation or numbness in residual limb.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Participants first received the crossover foot, then switched to the energy storing |
Not provided
Not provided
Small clinical population & resultant study sample size, disallowing inferential statistical analysis; COVID-19 pandemic resulting in cessation of human subjects research prior to obtaining data on all enrolled subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Conrad Slater | University of Washington | 5409318478 | conslate13@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2019 | Oct 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2019 | Oct 17, 2020 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Energy Storing Foot | Device | A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket. |
|
| Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2) |
| Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2 | Self-reported measure of mobility, the PLUS-M 12-item Short Form is a single measure, scores range from 17.5-76.6, higher scores represent better mobility. | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Change in Activities-Specific Balance Confidence Scale (ABC) | Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence. | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction | Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome) | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
| NOT COMPLETED |
|
Participants first received an energy storing foot, then switched to a crossover foot
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Amputation Etiology | Count of Participants | Participants |
|
| MFCL | Medicare Functional Classification Level (K-level) Graded as K-level 0 through 4. K0 indicates the individual does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. The increasing levels indicate higher levels of function, with K4 indicating the individual has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels; typical of the prosthetic demands of the child, active adult, or athlete. | Count of Participants | Participants |
|
|
|
| Primary | Total Prosthetic Ankle Range of Motion | The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion & plantarflexion) during stance phase between prosthetic feet, in degrees | Posted | Number | degrees | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| Primary | Prosthetic-side Energy Return | Intersegmental flow of power out of the prosthesis | Posted | Number | W/kg | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| Primary | Peak Sound-side Limb Loading | Maximum vertical ground reaction force in early stance | Posted | Number | Ratio (Newtons/body weight) | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| Secondary | Preference Questionnaire | At the end of the study, participants will engage in a preference questionnaire with open-ended follow-up questions to elicit preferences and experiences with both feet. Questions will ask about overall preference, and preference for a range of mobility activities (e.g., "Which foot did you prefer overall, and why?" and "Which foot did you prefer for walking up stairs, and why?"). | Posted | Count of Participants | Participants | Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2) |
|
|
|
| Secondary | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2 | Self-reported measure of mobility, the PLUS-M 12-item Short Form is a single measure, scores range from 17.5-76.6, higher scores represent better mobility. | Posted | Number | score on a scale | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| Secondary | Change in Activities-Specific Balance Confidence Scale (ABC) | Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence. | Posted | Number | score on a scale | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| Secondary | Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction | Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome) | Posted | Number | score on a scale | Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Participants first received the energy storing foot, then switched to the crossover foot | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
| Crossover Foot, Comfortable Walking Speed |
|
| Energy Storing Foot, Comfortable Walking Speed |
|
| Crossover Foot, Fast Walking Speed |
|
| Energy Storing Foot, Fast Walking Speed |
|
| Crossover Foot, Comfortable Walking Speed |
|
| Energy Storing Foot, Comfortable Walking Speed |
|
| Crossover Foot, Fast Walking Speed |
|
| Energy Storing Foot, Fast Walking Speed |
|
| Crossover Foot, Comfortable Walking Speed |
|
| Energy Storing Foot, Comfortable Walking Speed |
|
| Crossover Foot, Fast Walking Speed |
|
| Energy Storing Foot, Fast Walking Speed |
|
| No preference |
|
| Not applicable |
|
| Walking on declines |
|
| Ascending stairs |
|
| Descending stairs |
|
| Walking slowly |
|
| Walking quickly |
|
| Running |
|
| Walking over uneven terrain |
|
| Standing up from a chair |
|
| Sitting down in a chair |
|
| Turning on the prosthetic side |
|
| Getting in and out of a car |
|
| Playing sports |
|
| Standing for long periods |
|
| Walking in sand |
|
| Walking when you can't see your feet |
|
| Walking when carrying a heavy load |
|
| Walking in small spaces |
|
| Dancing |
|
| Riding a bicycle |
|