Falls in Older Persons With Limb Loss

Elderly Clinical Trial

— FOPLL  

Official title:

Sensory-Motor Mechanisms Underlying Fall Risk in Transtibial Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670004
• Other study ID #: C1322-W
• Secondary ID: IK2RX001322
• Status: Completed
• Start date: February 2, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Elderly

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 month
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.	1 month
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)	1 month
Secondary	Falls	Number of falls during 12 months prospectively	1 year