PROGYM

Project objectives

Restoring walking ability is one of the primary goals in the rehabilitation process for stroke survivors. During rehabilitation, when trunk control allows, exercises are performed to restore upright posture and subsequently regain walking ability. During the upright posture recovery phase, knee-ankle-foot-control orthoses (KAFOs) are often prescribed.tostiIt is known for its inhibitory effect on normal gait patterns and its interference with gait training. During the gait recovery phase, if active knee control activity occurs, the KAFO can be replaced by an ankle-foot orthosis (AFO). The project's primary objective is to experimentally evaluate, optimize, and engineer a prototype KAFO-AFO brace for the lower limb designed by Ortopedia Territi. The brace's strong innovation lies in its modularity, which gives a single system the ability to perform the challenging task of replacing traditional thigh-leg-foot, thigh-leg, and leg-foot orthoses while simultaneously attempting to

1. maintain the rehabilitation prerogatives intact and accompany the rehabilitation process in the most appropriate, comfortable and economical way

2. minimize the negative aspects essentially linked to excessive weight, aesthetics and limited functionality.

The modular thigh-leg-foot brace consists primarily of a knee orthosis and an ankle orthosis that can be used in combination or individually depending on the patient's specific needs (e.g., improved motor skills following rehabilitation) or the therapist's needs (e.g., specific rehabilitation exercise requirements). Furthermore, the individual modules can be adapted and easily replaced during therapy to monitor the patient's clinical development, allowing for customization of the brace for each individual patient. The project integrates medical and engineering expertise to provide an objective and scientifically rigorous evaluation of the potential of the modular thigh-leg-foot brace in a dedicated clinical study on hemiplegic patients. This study involves comparison with a control group (16 healthy subjects) and a group of hemiplegics wearing commercial braces, using quantitative performance indicators. The study enrolls patients with post-acute outcomes from ischemic or hemorrhagic stroke with right or left hemiplegia/hemiparesis, who are randomly assigned to either the commercial orthosis or the prototype orthosis. The functional evaluation is conducted in two phases. The first involves the use of bioengineering tools for kinematic and dynamic gait analysis. To this end, a preliminary investigation is conducted at the beginning of the project to identify the most suitable motion analysis technologies for the study, starting with Liberty/Polhemus electromagnetic induction systems or wearable systems based on magneto-inertial units, used by theUniversità Campus Bio-Medico di Roma In previous studies, more complex stereophotogrammetric systems have been developed, based on the combined use of infrared cameras and reflective markers positioned on the leg at appropriate anatomical landmarks, along with software for reconstructing the markers' motion in space. The kinematic reconstruction systems for the lower limb motion are used in conjunction with a sensorized platform to detect and measure ground reaction forces during postural stance and walking. The second phase is based on the administration of clinical scales such as the Barthel Index for independence, the SF-36 for quality of life, a cost analysis, and a questionnaire assessing patient satisfaction. The trial also defines the technical and functional specifications of a sensory system to be integrated into the brace to allow monitoring of kinematic and dynamic parameters of the patient's limb during use. The possibility of integrating sensors into the brace to read the position of the leg joints, sensors to measure the pressure exerted by the brace on the leg, and sensors to measure ground reaction force is being evaluated. Monitoring these parameters has the threefold objective of enriching the functional assessment of the patient's motor recovery with a quantitative description of motor performance (in addition to the assessment with clinical scales); monitoring the patient's recovery status and consequently making modifications, adjustments, or adaptations to parts of the brace in a manner consistent with the patient's evolving condition; and verifying and preventing the formation of any bedsores due to contact between the patient's leg and the brace parts. The creation of a sensorized thigh-leg-foot brace is certainly one of the most innovative and ambitious aspects of the project, even compared to the current landscape of commercial braces.

Start and end date

01/07/2009 - 01/07/2012

Project Manager

prof Silvia Sterzi - Scientific Tutor

Coordinating institution of the project

Università Campus Bio-Medico di Roma - Biomedical Engineering and Biomicrosystems Laboratory – Physical Medicine and Rehabilitation Unit

Other Institutions involved

TERRITI ORTHOPAEDICS

Funding source(s).

FILAS, art. 182 paragraph 4 letter c of the Regional Law 04/06 – PST, ITINERIS2