Amputation, Elderly
Conditions
Keywords
Artificial Limbs, Amputation, Accidental Falls, Stability, Balance, Gait, Electromyography
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for the recruitment of subjects with below knee amputation include: * Transtibial amputation * Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device * Classified as Medicare Functional Classification Level K2- defined as a patient who has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces - a typical community ambulator * Experience walking with a prosthesis for at least one year * Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, infections) * Normal or corrected vision * Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk Inclusion criteria for the recruitment of able-bodied controls include: * Normal or corrected vision * Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk * Suffered one or no falls in the previous 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | 1 month | 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. |
| Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | 1 month | 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. |
| Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | 1 month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls | 1 year | Number of falls during 12 months prospectively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unilateral Below Knee Amputation Individuals who walk with a below knee prosthesis | 13 |
| Non-Impaired Able-bodied controls | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | Unilateral Below Knee Amputation | Total | Non-Impaired |
|---|---|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 3.8 | 71.4 years STANDARD_DEVIATION 3.9 | 71.7 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 23 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 8 Participants |
| Region of Enrollment United States | 13 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 1 / 13 | 0 / 10 |
Outcome results
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.
Time frame: 1 month
Population: Sway area was measured for each limb for each vision condition of eyes open or closed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unilateral Below Knee Amputation | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Dominant/Sound, eyes open | 1.26 cm*cm | Standard Deviation 1.12 |
| Unilateral Below Knee Amputation | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Non-dominant/Impaired, eyes open | 0.66 cm*cm | Standard Deviation 0.48 |
| Unilateral Below Knee Amputation | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Dominant/Sound, eyes closed | 1.22 cm*cm | Standard Deviation 0.94 |
| Unilateral Below Knee Amputation | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Non-dominant/Impaired, eyes closed | 0.64 cm*cm | Standard Deviation 0.43 |
| Non-Impaired | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Non-dominant/Impaired, eyes closed | 0.76 cm*cm | Standard Deviation 0.81 |
| Non-Impaired | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Dominant/Sound, eyes open | 0.99 cm*cm | Standard Deviation 1.39 |
| Non-Impaired | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Dominant/Sound, eyes closed | 0.79 cm*cm | Standard Deviation 0.8 |
| Non-Impaired | Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared | Non-dominant/Impaired, eyes open | 0.71 cm*cm | Standard Deviation 0.67 |
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.
Time frame: 1 month
Population: Foot clearance was measured for each limb at each walking speed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unilateral Below Knee Amputation | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Non-dominant/Impaired, normal speed | 6.1 cm | Standard Deviation 1.5 |
| Unilateral Below Knee Amputation | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Dominant/Sound, normal speed | 6.1 cm | Standard Deviation 1.3 |
| Unilateral Below Knee Amputation | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Non-dominant/Impaired, fast speed | 5.1 cm | Standard Deviation 1.2 |
| Unilateral Below Knee Amputation | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Dominant/Sound, fast speed | 4.7 cm | Standard Deviation 0.7 |
| Non-Impaired | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Dominant/Sound, fast speed | 4.2 cm | Standard Deviation 0.9 |
| Non-Impaired | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Non-dominant/Impaired, normal speed | 5.5 cm | Standard Deviation 1.2 |
| Non-Impaired | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Non-dominant/Impaired, fast speed | 4.1 cm | Standard Deviation 0.8 |
| Non-Impaired | Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter | Dominant/Sound, normal speed | 5.7 cm | Standard Deviation 1.3 |
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)
Time frame: 1 month
Population: Integrated EMG was measured for each muscle group of interest at each walking speed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unilateral Below Knee Amputation | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Tibilias Anterior, normal speed | 0.278 mv*sec | Standard Deviation 0.069 |
| Unilateral Below Knee Amputation | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Tibilias Anterior, fast speed | 0.372 mv*sec | Standard Deviation 0.096 |
| Unilateral Below Knee Amputation | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Gastroc, normal speed | 0.360 mv*sec | Standard Deviation 0.041 |
| Unilateral Below Knee Amputation | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Gastroc, fast speed | 0.307 mv*sec | Standard Deviation 0.063 |
| Non-Impaired | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Gastroc, fast speed | 0.318 mv*sec | Standard Deviation 0.123 |
| Non-Impaired | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Tibilias Anterior, normal speed | 0.306 mv*sec | Standard Deviation 0.067 |
| Non-Impaired | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Gastroc, normal speed | 0.256 mv*sec | Standard Deviation 0.079 |
| Non-Impaired | Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds | Dominant/Sound Tibilias Anterior, fast speed | 0.348 mv*sec | Standard Deviation 0.098 |
Secondary
Falls
Number of falls during 12 months prospectively
Time frame: 1 year
Population: Total number of falls 12 months prospectively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unilateral Below Knee Amputation | Falls | 18 Falls |
| Non-Impaired | Falls | 10 Falls |