N/A
N=23
Falls in Older Persons With Limb Loss
Amputation · Elderly
Bottom Line
View on ClinicalTrials.gov: NCT03670004 ↗Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Nov 2022
Primary outcome: Primary: Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter — 6.1; 5.5; 6.1; 5.7 cm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter |
6.1; 5.5; 6.1; 5.7; 5.1; 4.1 | — |
| PRIMARY Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared |
1.26; 0.99; 0.66; 0.71; 1.22; 0.79 | — |
| 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 |
0.278; 0.306; 0.372; 0.348; 0.360; 0.256 | — |
| SECONDARY Falls |
18; 10 | — |
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.
Eligibility Criteria
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
Exclusion Criteria
Exclusion criteria for all recruited subjects (i.e., limb loss and control) include:
- Musculoskeletal (apart from amputation in the case of amputee subjects) and/or vestibular pathologies that would affect balance and/or stability
- Currently on medication that might affect proprioception and/or balance (e.g., drugs that are ototoxic, such as certain Aminoglycosides and pain killers)
- Cognitive deficits that preclude understanding of the instructions required to conduct the test
Data sourced from ClinicalTrials.gov (NCT03670004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.