Trial Outcomes & Findings for Falls in Older Persons With Limb Loss (NCT NCT03670004)
NCT ID: NCT03670004
Last Updated: 2022-11-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
23 participants
Primary outcome timeframe
1 month
Results posted on
2022-11-07
Participant Flow
Participant milestones
| Measure |
Unilateral Below Knee Amputation
Individuals who walk with a below knee prosthesis
|
Non-Impaired
Able-bodied controls
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Falls in Older Persons With Limb Loss
Baseline characteristics by cohort
| Measure |
Unilateral Below Knee Amputation
n=13 Participants
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=10 Participants
Able-bodied controls
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
71.4 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Foot clearance was measured for each limb at each walking speed
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.
Outcome measures
| Measure |
Unilateral Below Knee Amputation
n=26 Limbs
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=20 Limbs
Able-bodied controls
|
|---|---|---|
|
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
|
5.5 cm
Standard Deviation 1.2
|
|
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
|
5.7 cm
Standard Deviation 1.3
|
|
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
|
4.1 cm
Standard Deviation 0.8
|
|
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
|
4.2 cm
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Sway area was measured for each limb for each vision condition of eyes open or closed
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.
Outcome measures
| Measure |
Unilateral Below Knee Amputation
n=26 limbs
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=20 limbs
Able-bodied controls
|
|---|---|---|
|
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
|
0.71 cm*cm
Standard Deviation 0.67
|
|
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
|
0.99 cm*cm
Standard Deviation 1.39
|
|
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
|
0.79 cm*cm
Standard Deviation 0.80
|
|
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
|
0.76 cm*cm
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Integrated EMG was measured for each muscle group of interest at each walking speed
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)
Outcome measures
| Measure |
Unilateral Below Knee Amputation
n=26 Muscle group
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=20 Muscle group
Able-bodied controls
|
|---|---|---|
|
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
|
0.306 mv*sec
Standard Deviation 0.067
|
|
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
|
0.348 mv*sec
Standard Deviation 0.098
|
|
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
|
0.256 mv*sec
Standard Deviation 0.079
|
|
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
|
0.318 mv*sec
Standard Deviation 0.123
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Total number of falls 12 months prospectively
Number of falls during 12 months prospectively
Outcome measures
| Measure |
Unilateral Below Knee Amputation
n=13 Participants
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=10 Participants
Able-bodied controls
|
|---|---|---|
|
Falls
|
18 Falls
|
10 Falls
|
Adverse Events
Unilateral Below Knee Amputation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Impaired
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unilateral Below Knee Amputation
n=13 participants at risk
Individuals who walk with a below knee prosthesis
|
Non-Impaired
n=10 participants at risk
Able-bodied controls
|
|---|---|---|
|
General disorders
Head Injury
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place