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| ID | Type | Description | Link |
|---|---|---|---|
| IK2RX001322 | U.S. NIH Grant/Contract | View source |
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Lower limb prosthesis users are known to be at a substantially increased fall risk compared to able-bodied individuals. The interaction between increased fall risk, reduced balance confidence and high prevalence of a fear of falling often leads to restricted mobility and loss of independence. Critically, the cause of these falls and the role that inherent balance plays in fall risk is poorly understood. This study proposes to identify key differences in balance and mobility between older below-knee prosthesis users and able-bodied individuals. By further understanding the differences between these groups and relationships between fall risk and various outcome measures, intervention techniques can be developed to improve functional balance. An improvement in upright balance will reduce the occurrence of falls and fall related injuries in this veteran population, as well as increase their participation in daily activities and improve their quality of life.
Previous studies have shown that persons with transtibial amputations (TTA) are at a substantially increased risk of falling as compared to able-bodied age-matched controls and have reduced confidence in their balance, both contributing to their restricted mobility and daily activity. This risk increases with progressing age, as aging affects musculoskeletal and somatosensory systems that are vital to controlling upright balance (i.e., maintaining the body center-of-mass (BCoM) within the limits of the base-of-support) and are already compromised in persons with TTA. An important consequence of elevated fall incidence is an increased risk of fall-related injuries that may lead to lost participation and independence. The effects of reduced sensory-motor function on upright balance in older adults has been extensively studied and led to development of effective assessment tools and intervention strategies to minimize fall risk. However, the dearth of similar studies and relatively poor understanding of the effects of additional complications from TTA on upright balance have significantly hampered progress towards addressing this important concern for Veterans with TTA. Consequently, this limits knowledge of predictive factors of falls among these prosthesis users and for informing therapeutic interventions that enhance functional balance. Therefore, the primary objective of this research is to develop an improved understanding of the sensory-motor mechanisms underlying upright balance and fall risk in older Veterans with TTA. The proposed study will compare differences between two age- and gender-matched groups: 1) older unilateral prosthesis users and 2) able-bodied controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral Below Knee Amputation | Individuals who walk with a below knee prosthesis | ||
| Non-Impaired | Able-bodied controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Foot clearance of self-selected normal and fast speed walking, calculated as the distance (cm) between the toe and ground as measured with an optical motion capture system. | 1 month |
| Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Center of pressure sway area during eyes open or closed, calculated as the area (cm*cm) covered by the center of pressure position during standing as measured with a force plate. | 1 month |
| Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Integrated Electromyography patterns of leg muscles during self-selected normal and fast speed walking as a proxy measure of muscle effort, calculated from integrating the muscle activity measured by sensors as voltage over time (mv*sec) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Number of falls during 12 months prospectively | 1 year |
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Inclusion Criteria:
Inclusion criteria for the recruitment of subjects with below knee amputation include:
Inclusion criteria for the recruitment of able-bodied controls include:
Exclusion Criteria:
Exclusion criteria for all recruited subjects (i.e., limb loss and control) include:
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Older ambulatory individuals with or without unilateral below-knee amputation
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Major, PhD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unilateral Below Knee Amputation | Individuals who walk with a below knee prosthesis |
| FG001 | Non-Impaired | Able-bodied controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unilateral Below Knee Amputation | Individuals who walk with a below knee prosthesis |
| BG001 | Non-Impaired | Able-bodied controls |
| 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 | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Foot clearance of self-selected normal and fast speed walking, calculated as the distance (cm) between the toe and ground as measured with an optical motion capture system. | Foot clearance was measured for each limb at each walking speed | Posted | Mean | Standard Deviation | cm | 1 month | Limbs | Limbs |
|
12 months prospectively
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Unilateral Below Knee Amputation | Individuals who walk with a below knee prosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head Injury | General disorders | Serious | Systematic Assessment | Head injury experienced from a fall during 12-month prospective fall data collection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Major | Jesse Brown VA Medical Center | 312-503-5731 | matthew.major2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2021 | Nov 3, 2021 | Prot_SAP_000.pdf |
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| 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 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Limbs |
|
|
| Primary | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Center of pressure sway area during eyes open or closed, calculated as the area (cm*cm) covered by the center of pressure position during standing as measured with a force plate. | Sway area was measured for each limb for each vision condition of eyes open or closed | Posted | Mean | Standard Deviation | cm*cm | 1 month | limbs | limbs |
|
|
|
| Primary | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Integrated Electromyography patterns of leg muscles during self-selected normal and fast speed walking as a proxy measure of muscle effort, calculated from integrating the muscle activity measured by sensors as voltage over time (mv*sec) | Integrated EMG was measured for each muscle group of interest at each walking speed | Posted | Mean | Standard Deviation | mv*sec | 1 month | Muscle group | Muscle group |
|
|
|
| Secondary | Falls | Number of falls during 12 months prospectively | Total number of falls 12 months prospectively | Posted | Number | Falls | 1 year |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 0 |
| 13 |
| EG001 | Non-Impaired | Able-bodied controls | 0 | 10 | 0 | 10 | 0 | 10 |
|
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| Dominant/Sound, eyes closed |
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| Non-dominant/Impaired, eyes closed |
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| Dominant/Sound Gastroc, normal speed |
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| Dominant/Sound Gastroc, fast speed |
|