The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study

NCT03296904 | Completed

• 1 other identifier: CYBERLEGs Plus Plus
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transfemoral Amputation

Keywords

Lower limb amputation; Wearable robotics

Outcome Measures

Primary Outcomes (1)

• Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.

  While performing the six-minute walk test, oxygen uptake will be assessed using a portable gas analyzer and will be considered as an objective measure of the physical effort.

  Before and after the familiarization/training period lasting one month.

Secondary Outcomes (6)

• Change in the self-perceived physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.

  Before and after the familiarization/training period lasting one month.

• Change in the cognitive effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules

  Before and after the familiarization/training period lasting one month.

• Change in the performance during stair climbing/descending with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.

  Before and after the familiarization/training period lasting one month.

• Change in the performance during sitting down/standing-up and turning with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules

  Before and after the familiarization/training period lasting one month.

• Change in gait asymmetry with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules

  Before and after the familiarization/training period lasting one month.

Study Arms (1)

CLs++

EXPERIMENTAL

Baseline assessment, intervention, final assessment

Device: CLs++

Interventions

CLs++ DEVICE

Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules

CLs++

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral trans-femoral amputation (any cause)
• Completed the post amputation rehabilitation process
• Medicare Functional Classification Level ≤ K3

You may not qualify if:

• Poor cognitive skills (Mini Mental State Examination)
• Severe anxiety or depression (State-Trait Anxiety Inventory Form Y and Beck Depression Inventory II, respectively)
• Relevant comorbidity (hemiplegia, degenerative nervous system diseases, hip or knee replacement, chronic heart failure, chronic obstructive pulmonary disease, act.)
• Stump pain/socket poor fitting
• Implantable cardiac devices (PMK and AICD)
• Inability to walk on a treadmill

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator
• Université Catholique de Louvain: collaborator
• Vrije Universiteit Brussel: collaborator
• University of Ljubljana: collaborator
• Össur Iceland ehf: collaborator
• IUVO Srl: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus

Florence, 50143, Italy

Location

Related Publications (10)

• Monaco V, Tropea P, Aprigliano F, Martelli D, Parri A, Cortese M, Molino-Lova R, Vitiello N, Micera S. An ecologically-controlled exoskeleton can improve balance recovery after slippage. Sci Rep. 2017 May 11;7:46721. doi: 10.1038/srep46721.

  PMID: 28492520 BACKGROUND

• d'Elia N, Vanetti F, Cempini M, Pasquini G, Parri A, Rabuffetti M, Ferrarin M, Lova RM, Vitiello N. Erratum to: Physical human-robot interaction of an active pelvis orthosis: toward ergonomic assessment of wearable robots. J Neuroeng Rehabil. 2017 Jun 5;14(1):51. doi: 10.1186/s12984-017-0262-x. No abstract available.

  PMID: 28583163 BACKGROUND

• Ruiz Garate V, Parri A, Yan T, Munih M, Molino Lova R, Vitiello N, Ronsse R. Experimental Validation of Motor Primitive-Based Control for Leg Exoskeletons during Continuous Multi-Locomotion Tasks. Front Neurorobot. 2017 Mar 17;11:15. doi: 10.3389/fnbot.2017.00015. eCollection 2017.

  PMID: 28367121 BACKGROUND

• Zheng E, Manca S, Yan T, Parri A, Vitiello N, Wang Q. Gait Phase Estimation Based on Noncontact Capacitive Sensing and Adaptive Oscillators. IEEE Trans Biomed Eng. 2017 Oct;64(10):2419-2430. doi: 10.1109/TBME.2017.2672720. Epub 2017 Feb 23.

  PMID: 28252387 BACKGROUND

• Motor primitive-based control for lower-limb exoskeletons Virginia Ruiz Garate, Andrea Parri , Tingfang Yan, Marko Munih, Raffaele Molino Lova, Nicola Vitiello, and Renaud Ronsse 6th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics (BioRob) June 26-29, 2016. U Town, Singapore, pag. 655-661.

  BACKGROUND

• Walking Assistance using Motor Primitives Virginia Ruiz Garate, Andrea Parri, Tingfang Yan, Marko Munih, Raffaele Molino Lova, Nicola Vitiello, and Renaud Ronsse. IEEE Robotics and Automation Magazine 2014, March 2016, pag.83-95.

  BACKGROUND

• Yuan K, Parri A, Yan T, Wang L, Munih M, Vitiello N, Wang Q. Fuzzy-logic-based hybrid locomotion mode classification for an active pelvis orthosis: Preliminary results. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3893-6. doi: 10.1109/EMBC.2015.7319244.

  PMID: 26737144 BACKGROUND

• Grazi L, Crea S, Parri A, Yan T, Cortese M, Giovacchini F, Cempini M, Pasquini G, Micera S, Vitiello N. Gastrocnemius myoelectric control of a robotic hip exoskeleton. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3881-4. doi: 10.1109/EMBC.2015.7319241.

  PMID: 26737141 BACKGROUND

• CYBERLEGs - A User-Oriented Robotic Transfemoral Prosthesis with Whole Body Awareness Control. Ambrožič L, Goršič M, Geeroms J, Flynn L, Molino Lova R, Kamnik R, Munih M, Vitiello N. IEEE Robotics and Automation Magazine 2014, vol. 21(4):82-93.

  BACKGROUND

• Gorsic M, Kamnik R, Ambrozic L, Vitiello N, Lefeber D, Pasquini G, Munih M. Online phase detection using wearable sensors for walking with a robotic prosthesis. Sensors (Basel). 2014 Feb 11;14(2):2776-94. doi: 10.3390/s140202776.

  PMID: 24521944 BACKGROUND

Related Links

• Official website of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus project

Study Officials

• Raffaele Molino Lova, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 29, 2017
• Study Start: June 26, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)