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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH1910507 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses. Traditional above-the-knee socket designs provide pelvic support that interferes with hip motion. They may also reduce the effort required from amputated limb hip muscles to stabilize the hip and amputated limb, risking further loss of muscle mass and strength beyond that due to amputation. Long-standing use of above-the-knee sockets with pelvic support may therefore intensify amputated limb muscle loss and weakness, leading to challenges with walking and balance, increasing the effort required to walk, and contributing to degenerative changes in the hips and knees. Alternative socket designs that lessen the loss of muscle mass and strength are therefore required.
The investigators have developed a new socket without pelvic support for above-the-knee prosthesis users called the Northwestern University Flexible Sub-Ischial Suction (NU-FlexSIS) Socket. This new socket design increases user comfort and is often preferred by users over sockets with pelvic support. This new socket does not lessen the mechanical function of the socket, or walking and balance performance. Our recent research suggests that walking with this new socket may also increase amputated limb hip muscle size. However, more research is needed to demonstrate that this new socket design improves amputated limb hip muscle strength and endurance, leading to better function.
A socket design that increases amputated limb hip muscle strength and endurance would provide a simple way to restore amputated limb hip muscle weakness in above-the-knee prosthesis users. Despite a considerable decrease in hip muscle size and strength due to amputation surgery, amputated limb hip muscles are expected to compensate for the loss of knee and ankle function by providing stability and propulsion during walking. Walking in the new socket design without pelvic support is expected to increase amputated limb hip muscle strength and endurance, providing an appealing alternative to traditional resistance training in order to retain hip muscle strength. Unlike traditional resistance training, using this new socket design would not require additional time or equipment, and may be effective just by walking in the home, community, or workplace. Due to existing infrastructure (e.g., ongoing clinical adoption of the NU-FlexSIS Socket, existing instructional materials and courses for fabrication and fitting of the NU-FlexSIS Socket, as well as a continuing partnership with Chicago's largest provider of prosthetic clinical care), the investigators anticipate being able to translate our research results to clinical practice by the end of the project period.
The investigators expect the results of the proposed pilot research project to directly and positively benefit the health and well-being of Service members, Veterans, and civilians who are above-the-knee prosthesis users. Benefits of increasing amputated limb hip muscle strength and endurance may include: i) improved control over the prosthesis, ii) better balance, iii) reduced effort to walk, and iv) protection against joint degeneration. For Service members these benefits could improve their performance on challenging and/or uneven ground, and increase the distance and speed they can walk or run. For Veterans, these benefits could lead to greater independence during activities of daily living, and fewer falls, reducing the physical and emotional burden on family members and caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline ischial containment to subischial socket | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS) | Device | The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal. Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA). |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Limb Hip Muscle Peak Torque at Baseline | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. | Baseline |
| Residual Limb Hip Muscle Peak Torque at 8-weeks | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure. | 8 weeks after intervention |
| Residual Limb Hip Muscle Peak Torque at 42-weeks | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure. | 42 weeks after intervention |
| Residual Limb Hip Muscle Endurance at Baseline | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. | Baseline |
| Residual Limb Hip Muscle Endurance at 8-weeks | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Four Square Step Test at Baseline | A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. | Baseline |
| Four Square Step Test at 8 Weeks |
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Inclusion Criteria: worn an ischial containment socket for ≥ 2 years, able to walk short distances (10 meters), ability to read, write, and speak English, ≥ 2 years using a liner-based suspension, and a residual limb length ≥ 5".
Exclusion Criteria: amputation of a second leg, contralateral complications (e.g., hip replacement), or other major neuromusculoskeletal or cardiovascular conditions (e.g., heart failure).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Ischial Containment to Subischial Socket | Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS): The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal. Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline in Ischial Containment Socket |
| |||||||||||||
| 8-week Follow up in Sub-ischial Socket |
| |||||||||||||
| 42-week Follow up in Sub-ischial Socket |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Ischial Containment to Subischial Socket | Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS): The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal. Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA). |
| 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 | Residual Limb Hip Muscle Peak Torque at Baseline | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | Baseline |
|
Adverse event data were collected for 42 weeks.
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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 | Baseline Ischial Containment to Subischial Socket | Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS): The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal. Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA). |
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One participant dropped out prior to his week-42 follow up visit due to a medical condition unrelated to the study. Assessing hip muscle endurance as a decrease in performance over a set of 15 trials is not effective in transfemoral prosthesis users. Rather, a single 30 second trial, and comparing the first 3 and last 3 seconds is recommended.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Sawers | University of Illinois Chicago | 312-996-1427 | asawers@uic.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 | Aug 8, 2019 | Mar 21, 2024 | Prot_SAP_000.pdf |
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Transfemoral amputees who historically have worn an ischial containment prosthetic socket will be assessed at baseline, fit with the intervention (a sub-ischial socket), and then tested at 8 and 42 weeks after intervention. All comparisons will be made back to baseline.
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| 8 weeks after intervention |
| Residual Limb Hip Muscle Endurance at 42-weeks | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure. | 42 weeks after intervention |
| Residual Limb Hip Muscle Duration at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | Baseline |
| Residual Limb Hip Muscle Duration at 8-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | 8 weeks after intervention |
| Residual Limb Hip Muscle Duration at at 42-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | 42 weeks |
| Residual Limb Hip Muscle Integrated Area at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | Baseline |
| Residual Limb Hip Muscle Integrated Area at 8-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | 8 weeks after intervention |
| Residual Limb Hip Muscle Integrated Area at 42-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | 42 weeks after intervention |
| Peak Residual Limb Hip Muscle Activity at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | Baseline |
| Peak Residual Limb Hip Muscle Activity at 8 Weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | 8 weeks after intervention |
| Peak Residual Limb Hip Muscle Activity at 42 Weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | 42 weeks after intervention |
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. |
| 8-weeks after intervention |
| Four Square Step Test at 42 Weeks | A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. | 42-weeks after intervention |
| One Leg Stance Test at Baseline | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | Baseline |
| One Leg Stance Test at 8 Weeks | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | 8 weeks after intervention |
| One Leg Stance Test at 42 Weeks | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | 42 weeks after intervention |
| 10-Meter Walk Test at Baseline | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | Baseline |
| 10-Meter Walk Test at 8 Weeks | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | 8 weeks after intervention |
| 10-Meter Walk Test at 42 Weeks | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | 42 weeks after intervention |
| 2-Minute Walk Test at Baseline | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | Baseline |
| 2-Minute Walk Test at 8 Weeks | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | 8-weeks after intervention. |
| 2-Minute Walk Test at 42 Weeks | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | 42-weeks after intervention. |
| Volume of Physical Activity at Baseline | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | 2 weeks prior to intervention (baseline) |
| Volume of Physical Activity at 8 Weeks | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | 8-weeks after intervention |
| Volume of Physical Activity at 42 Weeks | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | 42-weeks after intervention |
| Frequency of Physical Activity at Baseline | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 2 weeks prior to intervention (baseline) |
| Frequency of Physical Activity at 8 Weeks | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 8 weeks after intervention |
| Frequency of Physical Activity at 42 Weeks | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 42 weeks after intervention |
| Duration of Physical Activity at Baseline | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 2 weeks prior to intervention (baseline) |
| Duration of Physical Activity at 8 Weeks | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 8 weeks after intervention |
| Duration of Physical Activity at 42 Weeks | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | 42 weeks after intervention |
|
| 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 |
|
| Body mass | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | meters |
|
| Residual limb length | Mean | Standard Deviation | cm |
|
| Time since amputation | Mean | Standard Deviation | years |
|
| Cause of amputation | Count of Participants | Participants |
|
| Medicare Functional Classification Level (K-Level) | The Medicare Functional Classification Level (MFCL) K level is a 0 to 4 point scale of mobility for those with limb loss. A higher K level implies greater mobility potential. K-level determined by prosthetist. The MFCL levels are described as: K0 - Does not have the ability or potential to ambulate or transfer safely with a prosthesis K1 - Limited and unlimited household ambulator K2 - Limited community ambulator K3 - Community ambulator who has the ability to traverse most environmental barriers K4 - Potential for prosthetic ambulation that exceeds the basic ambulation skills | Count of Participants | Participants |
|
| Number of falls in past 12 months | Mean | Standard Deviation | falls |
|
| Activities-specific Balance Confidence Scale score | Scale name: Activities-specific Balance Confidence (ABC) Scale Scale construct: balance self-efficacy Scale range (min/max): min = 0, max=4 A higher ABC scale score implies greater balance self-efficacy (i.e., confidence) | Mean | Standard Deviation | units on a scale 0 to 4 |
|
| Prosthesis Limb Users Survey of Mobility | Scale name: Prosthetic Limb Users Survey of Mobility (PLUS-M) is a self-report instrument for measuring mobility of adults with lower limb amputation. Scale construct: perceived mobility Scale range (min/max): min = 21.8, max=71.4 A higher PLUS-M score implies greater balance perceived mobility. | Mean | Standard Deviation | units on a scale |
|
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| Primary | Residual Limb Hip Muscle Peak Torque at 8-weeks | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | 8 weeks after intervention |
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| Primary | Residual Limb Hip Muscle Peak Torque at 42-weeks | Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | 42 weeks after intervention |
|
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| Primary | Residual Limb Hip Muscle Endurance at Baseline | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | Baseline |
|
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| Primary | Residual Limb Hip Muscle Endurance at 8-weeks | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | 8 weeks after intervention |
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| Primary | Residual Limb Hip Muscle Endurance at 42-weeks | Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure. | Posted | Mean | 95% Confidence Interval | newton-meters / kg*meters | 42 weeks after intervention |
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| Primary | Residual Limb Hip Muscle Duration at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | Posted | Mean | 95% Confidence Interval | percentage | Baseline |
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| Primary | Residual Limb Hip Muscle Duration at 8-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | Posted | Mean | 95% Confidence Interval | percentage | 8 weeks after intervention |
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| Primary | Residual Limb Hip Muscle Duration at at 42-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration. | Posted | Mean | 95% Confidence Interval | percentage | 42 weeks |
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| Primary | Residual Limb Hip Muscle Integrated Area at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | Posted | Mean | 95% Confidence Interval | percentage of maximum value | Baseline |
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| Primary | Residual Limb Hip Muscle Integrated Area at 8-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | Posted | Mean | 95% Confidence Interval | percentage of maximum | 8 weeks after intervention |
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| Primary | Residual Limb Hip Muscle Integrated Area at 42-weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active. | Posted | Mean | 95% Confidence Interval | percentage of maximum | 42 weeks after intervention |
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| Primary | Peak Residual Limb Hip Muscle Activity at Baseline | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | Posted | Mean | 95% Confidence Interval | mV | Baseline |
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| Primary | Peak Residual Limb Hip Muscle Activity at 8 Weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | Posted | Mean | 95% Confidence Interval | mV | 8 weeks after intervention |
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| Primary | Peak Residual Limb Hip Muscle Activity at 42 Weeks | Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle. | Posted | Mean | 95% Confidence Interval | mV | 42 weeks after intervention |
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| Secondary | Four Square Step Test at Baseline | A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. | Posted | Mean | 95% Confidence Interval | seconds | Baseline |
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| Secondary | Four Square Step Test at 8 Weeks | A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. | Posted | Mean | 95% Confidence Interval | seconds | 8-weeks after intervention |
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| Secondary | Four Square Step Test at 42 Weeks | A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials. | Posted | Mean | 95% Confidence Interval | seconds | 42-weeks after intervention |
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| Secondary | One Leg Stance Test at Baseline | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | Posted | Mean | 95% Confidence Interval | seconds | Baseline |
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| Secondary | One Leg Stance Test at 8 Weeks | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | Posted | Mean | 95% Confidence Interval | seconds | 8 weeks after intervention |
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| Secondary | One Leg Stance Test at 42 Weeks | A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance. | Posted | Mean | 95% Confidence Interval | seconds | 42 weeks after intervention |
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| Secondary | 10-Meter Walk Test at Baseline | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | Posted | Mean | 95% Confidence Interval | meters/second | Baseline |
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| Secondary | 10-Meter Walk Test at 8 Weeks | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | Posted | Mean | 95% Confidence Interval | meters/second | 8 weeks after intervention |
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| Secondary | 10-Meter Walk Test at 42 Weeks | The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used. | Posted | Mean | 95% Confidence Interval | meters/second | 42 weeks after intervention |
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| Secondary | 2-Minute Walk Test at Baseline | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | Posted | Mean | 95% Confidence Interval | meters | Baseline |
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| Secondary | 2-Minute Walk Test at 8 Weeks | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | Posted | Mean | 95% Confidence Interval | meters | 8-weeks after intervention. |
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| Secondary | 2-Minute Walk Test at 42 Weeks | The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance. | Posted | Mean | 95% Confidence Interval | meters | 42-weeks after intervention. |
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| Secondary | Volume of Physical Activity at Baseline | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of steps per activity bout | 2 weeks prior to intervention (baseline) |
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| Secondary | Volume of Physical Activity at 8 Weeks | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of steps per activity bout | 8-weeks after intervention |
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| Secondary | Volume of Physical Activity at 42 Weeks | To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of steps per activity bout | 42-weeks after intervention |
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| Secondary | Frequency of Physical Activity at Baseline | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of activity bouts per day | 2 weeks prior to intervention (baseline) |
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| Secondary | Frequency of Physical Activity at 8 Weeks | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of activity bouts per day | 8 weeks after intervention |
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| Secondary | Frequency of Physical Activity at 42 Weeks | To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean number of activity bouts per day | 42 weeks after intervention |
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| Secondary | Duration of Physical Activity at Baseline | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean time (in minutes) of activity bouts | 2 weeks prior to intervention (baseline) |
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| Secondary | Duration of Physical Activity at 8 Weeks | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean time (in minutes) of activity bouts | 8 weeks after intervention |
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| Secondary | Duration of Physical Activity at 42 Weeks | To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity. | Posted | Mean | 95% Confidence Interval | mean time (in minutes) of activity bouts | 42 weeks after intervention |
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Not provided
Not provided
| Title | Measurements |
|---|---|
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| Hip adduction |
|
| Title | Measurements |
|---|---|
|
| Hip adduction |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor Magnus |
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| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Gluteus medius |
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|
| Title | Measurements |
|---|---|
|
| Tensor fascia latae |
|
| Rectus femoris |
|
| Adductor magnus |
|