Falls in Older Persons With Limb Loss
Completed
Conditions studied: Amputation, Elderly
In brief
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.
Key facts
- Study ID
- NCT03670004
- Run by
- VA Office of Research and Development
- People needed
- 23
- Starts
- 2017-02-02
- Expected to finish
- 2020-10-31
- Last updated by the study team
- 2022-11-07
Who can join
Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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