NEW YORK — Rehabilitation and its possible effects are rarely part of the research that goes into the design or evaluation of prosthetic componentry, according to a prospective new study.
Yet, according to the research led by the VA New York Harbor Healthcare System and the Walter Reed National Military Medical Center in Bethesda, MD, evidence has suggested that rehabilitation is critical for minimizing gait imbalances.
Also participating in the study were the Extremity Trauma and Amputation Center of Excellence in, Falls Church, VA; the VA’s National Veterans Sports Programs and Special Events in Washington, DC; the Uniformed Services University of the Health Sciences in Bethesda; the Narrows Institute for Biomedical Research and Education in Brooklyn, NY; and the James A. Haley Veterans’ Hospital in Tampa, FL.
“Powered ankle-foot prosthetic devices can generate net positive mechanical work during gait, which mimics the physiological ankle,” the authors wrote in JMIR Research Protocols. “However, gait deviations can persist in individuals with transfemoral limb loss because of habit or lack of rehabilitation.”
The researchers pointed out the accelerated rate of innovation in prosthetics but decried the fundamental knowledge gap “concerning how individuals with transfemoral limb loss should learn to correctly use powered ankle-foot devices for maximum functional benefit.”
They also described the “critical” unmet need to develop guidelines for the prescription of advanced prosthetic devices, noting that those should include both physical and psychological components to identify appropriate candidates for advanced technology.
The investigation’s primary goal will be to examine the roles of advanced prosthetic technology and a device-specific rehabilitative intervention on gait biomechanics, functional efficacy and pain in individuals with transfemoral limb loss. Defined as the secondary goal was the development of preliminary rehabilitation guidelines for advanced lower limb prosthetic devices “to minimize gait imbalances and maximize function and to establish preliminary guidelines for powered ankle-foot prosthetic prescription.”
Included in the prospective, multisite study will be 30 patients with unilateral transfemoral limb loss. At baseline, participants will undergo a full gait analysis and assessment of function, neurocognition, cognitive load, subjective preferences and pain using their current passive prosthesis. The researchers then will fit the participants with a powered ankle-foot device. Half of the patients will receive a powered device with a device-specific rehabilitation intervention (Group A), and the other half will receive a powered device with the current standard of practice (Group B).
The authors advised that Group A will undergo four weeks of device-specific rehabilitation. Group B will receive the current standard of practice, which includes basic device education but no further device-specific rehabilitation, while data collection procedures will then be repeated after four weeks and eight weeks of powered ankle use.
The initial dissemination of results is expected in August 2024.
“The projected trends indicate that the number of individuals with limb loss will dramatically increase in the United States,” the study noted. “The absence of effective, evidence-based interventions may make individuals with transfemoral limb loss more susceptible to increased secondary physical conditions and degenerative changes. With this expected growth, considerable resources will be required for prosthetic and rehabilitation services. Identifying potential mechanisms for correcting gait asymmetries, either through advanced prosthetic technology or rehabilitative interventions, can provide a benchmark for understanding the optimal treatment strategies for individuals with transfemoral limb loss.”
- Maikos JT, Pruziner AL, Hendershot BD, Herlihy DV, et. Al. Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals With Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multisite Clinical Trial. JMIR Res Protoc. 2024 Jan 26;13:e53412. doi: 10.2196/53412. PMID: 38277197; PMCID: PMC10858430.
