The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
Condition: Transfemoral Amputation
Study type: Interventional

Summary: 
      The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++)
      project is to validate the technical and economic viability of the powered robotic
      ortho-prosthesis developed within the 7th Framework Program - Information and Communication
      Technology - CYBERnetic LowEr-limb coGnitive ortho-prosthesis project, as a means to enhance/
      restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks
      such as ground-level walking, climbing/descending stairs, standing up, sitting down and
      turning in scenarios of real life. Restored mobility will allow amputees to perform physical
      activity thus counteracting physical and cognitive decline which occurs with advancing age
      and improving the overall health status and quality of life.

      This project involves players from academia, research institutions, end users, as well as
      robotics and healthcare industry, and has been funded by the European Commission (call
      identifier H2020 - Information and Communication Technology 24-2015, scope c, namely
      Technology Transfer - Robotics use cases, Grant Agreement 731931).

      The CLs++ project is an Innovation Action (IA) and foresees 2 clinical studies aimed at
      assessing the efficacy of the CLs++ modules in different settings.

      In this 1st clinical study, 16 patients with unilateral trans-femoral amputation, 8 @ the Don
      Gnocchi Foundation, Center of Florence, and 8 @ the Free University of Brussels, Dept. of
      Human Physiology, will participate in the assessment of the efficacy of the CLs++
      ortho-prosthesis modules in a clinical setting.
    

Detailed description: 
      In the first clinical study, a set of combinations of the three hardware (HW) modules of the
      CLs++ ortho-prosthesis, namely the Active Trans-femoral Prosthesis (ATP), the Active Pelvis
      Orthosis (APO) and the Active Knee Orthosis (AKO) will be tested, along with the Wearable
      Sensory Apparatus (WSA), the Bidirectional Interface (BI) and the control software (SW).

      The recruitment of potential participants will be carried out by a multidisciplinary team
      (physicians, physiotherapists and psychologists) and will be aimed at ascertaining the
      inclusion and exclusion criteria as reported in the "Eligibility" section. If the potential
      participant fulfills the requirements to be enrolled, the responsible for the study will
      provide him/her with the information sheet and will answer all possible questions. Once the
      participant agrees to participate in the study, he/she will sign the informed consent form.
      An appointment will also be arranged with the orthopedic workshop to make a spare socket to
      be used with the ATP.

      The protocol of the CLs++ first clinical study will be constituted by two main phases.

      The first phase is expected to last one week and it has the goal to explore the functionality
      of the CLs++ HW and SW modules in structured or semi-structured clinical settings by means of
      a preliminary initial set of activities. In particular, the enrolled participants will be
      testing 4 different combinations of CLs++ modules:

      a) APO + WSA + BI; b) ATP + WSA; c) APO + ATP + WSA; d) APO + AKO + WSA.

      This set of experiments will allow to collect relevant data at the beginning of the protocol
      in order to assess the functionality of the CLs++ system for each participant. Furthermore,
      the appropriate combination of the three HW modules of the CLs++ ortho-prosthesis will be
      selected among one of the above combinations. The selection will be performed with
      participants walking overground and on a treadmill at their self-selected speed, to optimally
      match the specific user needs based on their residual movement ability and required movement
      assistance. Specifically, the appropriate combination of the CLs++ modules will be selected
      based on both the clinical evaluation (e.g. walking asymmetry, stump length,
      flexion-extension hip strength, strength of the contra-lateral limb) and the subjective
      feedback, in terms of comfort and perceived functionality, from the participant.

      Assessments will be performed at the beginning and at the end of the 1-month
      familiarization/training period, with participants wearing both their customized combination
      of the CLs++ modules and their own prosthesis only. The functional assessments will be
      performed using a treadmill to be able to control all variables: however, we will also
      perform some test during over-ground walking. In addition to the assessments reported in the
      section "Outcome Measures", the study foresees the administration of the System Usability
      Scale (SUS) to assess the usability of the CLs++ system. The study also foresees the
      development of ad-hoc tools for investigating the economic dimension.

      The second phase of the study will consist of an hospital-based familiarization/training
      walking on the treadmill and overground with the selected combination of CLs++ modules, 1
      hour 3 times a week for 1 month. Worthily, training sessions will be mainly focused on the
      familiarization to the use of the customized combination of CLs++ modules rather than on
      aerobic training. Thus, the work load, as expressed by the walking speed overground or on the
      treadmill, will not be critical. Further, participants will be asked to walk at their
      self-selected speed and will be allowed to stop walking whenever they feel tired and to start
      again walking once they have recovered.

      After 2 weeks of familiarization/training, the set of assessments can be repeated in order to
      assess whether the experience gained in the training period has effects on a different set of
      CLs++ modules. Notably, the initial set of modules identified for each patient will be kept
      unchanged for the whole duration of the familiarization/training, and the intermediate
      session will be used as evaluation means.

      From a statistical point of view, as reported in the "Study Design" section, a sample size of
      16 subjects will be able to detect a 15% change in walking-related physical effort, in terms
      of oxygen uptake during the six-minute walk test, in a single group of trans-femoral amputees
      with a statistical power > 0.9 at the two-sided 0.05 alpha-level. Descriptive statistics will
      be used to present results, while appropriate inferential statistics will be used to
      ascertain possible significant differences. Data will be also analysed following a
      case-series approach: data of each patient will be analysed separately in order to highlight
      the occurrence of differences between pre- and post- assessment sessions, or any learning
      effect over the familiarization/training time.
    

Intervention name(s): CLs++
Intervention type(s): Device
Intervention description(s): Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lower limb amputation; Wearable robotics