PROGYM: Programming, development and clinical validation of a thigh-leg-foot modular brace
Project objectives
Ambulation recovery is one of the main objectives of a subject’s post-stroke rehabilitation process. During rehabilitation, when allowed by trunk control status, exercises to recover upright standing position and then ambulation are carried out.
In the upright standing recovery stage, the prescription of orthotics for knee-ankle-foot control is often underestimated because of its inhibitory effect on normal ambulation patterns and its interference with ambulation training.
In the ambulation recovery stage, if there is some active knee-control activity, Knee-Ankle-Foot Orthotics (KAFO) can be substituted by an Ankle-Foot Orthotics (AFO). The project’s main objective is to experimentally assess, optimize and engineer a KAFO-AFO brace prototype for lower limbs, which was designed by Ortopedia Territi.
The highly innovative feature of this brace is its modularity that offers a single system to fulfil the difficult task of substituting classic thigh-leg-foot, thigh-leg and leg-foot orthotics, whilst trying, at the same time, to:
- Keep its rehabilitation features intact and follow the rehabilitation pathway in the most appropriate, comfortable and economical way.
- Minimize negative aspects essentially related to excessive weight, aesthetics and limited functionality.
The thigh-leg-foot modular brace is mainly composed of one orthotics for the knee and one for the ankle that can be used combined or separately according to the needs of the rehabilitative treatment (for instance an improvement in motor capacity following rehabilitation) or of the therapist (for instance according to characteristics of the exercise). Furthermore, the single modules can be adjusted and easily substituted during treatment in order to follow the patient’s clinical evolution, making it possible to “customize” the brace for each specific patient.
The project demonstrates the integration of medical and engineering competencies to provide an objective and scientifically rigorous assessment of thigh-leg-foot modular brace potentialities in an ad-hoc clinical trial on hemiplegic patients. The trail also involves comparison by quantitative performance indicators with a group of healthy subjects (16) and a group of hemiplegics wearing commercial braces. The study involves the enrollment of patients with post-acute outcomes of ischemic or hemorrhagic stroke with right or left hemiplegia/hemiparesthesia. These patients randomly receive either the commercial orthotics or the prototype.
The functional assessment is carried out in two stages. The first one involves the use of bioengineering instruments for cinematic and dynamic gait analysis. For this purpose, a preliminary survey has been carried out at the beginning of the projects to point out the most suitable movement analysis technologies for the study.
As already used in previous studies conducted at Campus Bio-Medico University of Rome, also in this study are used Liberty/Polhemus electromagnetic induction systems, wearable systems based on magneto-inertial units or more complex stereophotogrammetric systems of infrared video cameras and reflective markers positioned on the leg in appropriate anatomic landmarks and related software for motion reconstruction of marker in space.
The systems of lower limb motion cinematic reconstruction are used together with a sensor platform for the detection and measurement of ground reaction forces during static posture and walking.
The second phase on the contrary is based on the administration of clinical scales such as the Barthel Index for autonomy, SF-36 for quality of life, cost analysis and the patient’s satisfaction rate questionnaire. The aim of the trial includes the definition of technical and functional specifications of a sensor system to be integrated in the brace in order to monitor the cinematic and dynamic parameters of the patient’s limb during the use of the brace.
The possibility of integrating in the brace sensors to read leg articulation positions is also evaluated with sensors to measure pressure exerted by the brace on the leg and sensors to measure ground reaction force.
The monitoring of those parameters aims to:
- Upgrade the functional assessment of patient’s motion recovery with a quantitative description of motion performances (in addition to the clinical scale evaluation).
- Monitor the patient’s recovery status and eventually make changes, adjustments or adaptations to brace parts consistent with the patient’s evolving state.
- Verify and prevent the formation of possible pressure sores due to contact between the leg and brace parts.
The realization of a thigh-leg-foot brace with sensors is certainly one of the most innovative and ambitious aspects of the project, also when compared to current commercial braces.
Start/End Date
July 1, 2009 - July 1, 2012
Principal Investigator
Prof. Silvia Sterzi - Scientific Tutor
Host Institution
- Campus Bio-Medico University of Rome, Laboratory of Biomedical Engineering and Biomicrosystems
- Campus Bio-Medico University of Rome, Complex Operative Unit (U.O.C.) of Physical and Rehabilitation Medicine
Other Institutions involved
Ortopedia Territi
Source of funding
FILAS, art. 182 comma 4 letter c Regional Law 04/06 – PST, ITINERIS2