Transfemoral AmputationCLs++1stCSNCT03296904
The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
A study testing CLs++ in people with Transfemoral Amputation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- CLs++
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral trans-femoral amputation (any cause)
- Completed the post amputation rehabilitation process
- Medicare Functional Classification Level ≤ K3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study: Validation of the Efficacy of the CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus Modules in a Clinical Setting
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).
Read more
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.
Read the 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:
- 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.
- Conditions
- Transfemoral Amputation
- Being tested
- CLs++
- Keywords
- Lower limb amputation, Wearable robotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLs++Device
Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules
| Study group | Role | What they receive |
|---|---|---|
| CLs++ | Experimental | Baseline assessment, intervention, final assessment Receives: Device: CLs++ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
At the end of the six-minute walk test, the Borg Scale (CR-10) will be administered and the score will be considered as a measure of the perceived physical effort.
Measured: 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
The cognitive effort will be assessed through changes in the galvanic skin response (GSR), heart rate variability (HRV) and brain electrical activity (EEG) while performing two Dual Task tests, namely the backward counting and the Stroop test.
Measured: 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.
The performance in the above locomotion-related task will be assessed using the Stair Climbing Test (SCT).
Measured: 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
The performance in the above locomotion-related task will be assessed using the Timed get-Up and Go test (TUG)
Measured: 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
Gait asymmetry will be assessed using a motion capture system, either optoelectronic or marker-less.
Measured: Before and after the familiarization/training period lasting one month.
Change in muscle electrical activity with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules
Muscle electrical activity will be assessed using surface electromyography (sEMG)
Measured: Before and after the familiarization/training period lasting one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start26 Jun 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Université Catholique de Louvain, Vrije Universiteit Brussel, University of Ljubljana, Össur Iceland ehf, IUVO S.r.l.
- Responsible party
- Principal investigator, Raffaele Molino Lova, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Raffaele Molino Lova, MD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296904
- Sponsor's protocol ID
- CYBERLEGs Plus Plus
- Acronym
- CLs++1stCS
- Status last verified
- Dec 2019
- First submitted
- 19 Sep 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28492520d'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.
PubMed 28583163Ruiz 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.
PubMed 28367121Zheng 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.
PubMed 28252387Motor 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.
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.
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.
PubMed 26737144Grazi 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.
PubMed 26737141CYBERLEGs - 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.
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.
PubMed 24521944
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study: Validation of the Efficacy of the CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus Modules in a Clinical Setting
- ClinicalTrials.gov ID
- NCT03296904
- Acronym / sponsor ID
- CLs++1stCS / CYBERLEGs Plus Plus
- Conditions
- Transfemoral Amputation
- Keywords
- Lower limb amputation, Wearable robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Université Catholique de Louvain, Vrije Universiteit Brussel, University of Ljubljana, Össur Iceland ehf, IUVO S.r.l.
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLs++ | Experimental | Device: CLs++Baseline assessment, intervention, final assessment |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral trans-femoral amputation (any cause)
- Completed the post amputation rehabilitation process
- Medicare Functional Classification Level ≤ K3
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLs++Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules | Device | CLs++ |
Primary outcome
Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.
Time frame: Before and after the familiarization/training period lasting one month.
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.
6 secondary outcomes
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Before and after the familiarization/training period lasting one month.
Change in muscle electrical activity with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules
Time frame: Before and after the familiarization/training period lasting one month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Background: PubMed 28492520Monaco 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.
- Background: PubMed 28583163d'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.
- Background: PubMed 28367121Ruiz 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.
- Background: PubMed 28252387Zheng 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.
- BackgroundMotor 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.
- BackgroundWalking 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: PubMed 26737144Yuan 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.
- Background: PubMed 26737141Grazi 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.
- BackgroundCYBERLEGs - 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: PubMed 24521944Gorsic 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.
- Official website of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Molino Lova, MD principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLs++ in people with Transfemoral Amputation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules. (time frame: Before and after the familiarization/training period lasting one month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296904, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.