Knee InstabilityBELK@CCPNCT04173975
Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting (BELK@CCP)
A study testing With knee exoskeleton in people with Knee Instability and Neuromuscular Diseases, run by Casa di Cura Privata del Policlinico SpA.
Trial summary
This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Knee Instability, Neuromuscular Diseases, Central Nervous System Diseases
- What is being tested?
- With knee exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Aug 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 30 - 85
- Sex: males and females
- Diagnosis of Neuromuscular diseases (NMD) or central nervous system (CNS) disorder with knee instability conditioning gait
- Functional Ambulation Categories (FAC) > 3
- Mini Mental State Examination (MMSE) > 24
- Ability to walk at least 10 meters alone or with maximum 1 person assistance
Who cannot join
- Bilateral impairment of the knees
- Knee implant
- Lower extremity amputation
- Severe sensorial impairment of the lower limbs
- Legal blindness or severe visual impairment
- Pacemakers or metal implants
- Refusal to give informed consent
About this study
Official title: Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting
This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion during ADL.
Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on to the standard neuro-rehabilitation treatment. Gait analysis and Instrumental Test will be performed every week till the end of the six-week training period while the Clinical Scales and Questionnaires will be performed after three weeks and at the end of the training period. Finally, additional outcome measures comprise the scores on the System Usability Scale (SUS) to evaluate the hardware and the Software Usability Measurement Inventory (SUMI) to evaluate the software of the BELK orthosis. These two measures will be administrated at the end of training with Belk orthosis, to rate patients' and operators' (e.g., physical therapist, medical doctors) satisfaction.
Read more
During 2018, the company GOGOA (www.gogoa.eu), specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a first prototype of the BELK system, a powered wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. As BELK is a wearable device, it can be used both, by the physiotherapist in the rehabilitation centers, improving the knee rehabilitation process and increasing patients' comfort, and accelerating their rehabilitation process.
Casa di Cura del Policlinico (CCP https://www.ccppdezza.it/en/) is a fully integrated multi-specialty clinical center aiming at providing both inpatient and outpatient services mainly directed to neurological patients. The Center is constituted as a Department of Neuro-rehabilitation Sciences, accredited by the Italian National Health System, and economically supported by Regione Lombardia. CCP offers to chronic neurological patients the highest comprehensive standards of care in a comfortable environment, through a multidisciplinary patient management approach organized around a core rehabilitation program.
Read the detailed description
The study design comprises a clinical study aimed at assessing efficacy of the BELK orthosis knee module on management of instability of the knee in 15 adults who have NMD or a CNS disorder. Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on at the standard neurorehabilitation treatment.
The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis. The activities will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working).
This clinical study will be a Randomized Control Trial (RCT) crossover longitudinal.
The clinical trial will be split in the following phases :
- Recruitment. Subjects admitted to CCP Neurorehabilitation unit will be recruited after considering inclusion and exclusion criteria through clinical history and medical visit.
- Randomization. Enrolled participants will be randomly allocated (per 2 blocked randomization lists, generated electronically by www.random.org) into the BELK assisted group (Group A) or the control group (Group B).
- Clinical, instrumental and questionnaires assessment at T0 (baseline)
- Rehabilitation Treatment (first block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group A will perform the training wearing the BELK device while patients allocated in Group B will perform the same exercise without any exoskeleton.
- Clinical, instrumental and questionnaires assessment at T1 (crossover)
- Rehabilitation Treatment (second block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group B will perform the training wearing the BELK device while patients allocated in Group A will perform the same exercise without any exoskeleton.
- Clinical, instrumental, questionnaires and usability assessment at T2 (final)
- Additional Instrumental Test will be performed after the first and the second week of each rehabilitation treatment block (i.e., T01, T02, T11, T12).
Instrumental Test consist of:
- Bio-mechanical performance (gait kinematics/kinetics analysis),
- Surface electromyography for knee functional evaluation (EMG),
- 6-minute walking test (6mWT),
- Baseline assessments uptake (VO2),
- Hearth rate (HR),
- Breathing frequency (BF),
- Timed Up and Go Test (TUG),
- Stair Climb Test (SCT).
Clinical scales consist of:
- Functional Independence Measure scale (FIM),
- Functional Ambulation category scale (FAC),
- lower-leg Ashworth scale (sum of score for hip, knee and ankle) (AS),
- Mini Balance Evaluation Systems Test (Mini-Best),
- Motricity Index (MI),
- Self-reported perceived effort (CR-10 Borg).
Questionnaires consist of:
- International Knee Documentation Committee subjective knee evaluation form (IKDC),
- Knee Outcome Survey Activity of Daily Living (KOS ADL) and health-related quality of life (SF-36).
- Being tested
- With knee exoskeleton
- Medical subject headings
- Neuromuscular Diseases, Central Nervous System Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With knee exoskeletonDevice
BELK is a wearable system that assists when and where the patient needs it intelligently through proper control of the system and optimized gait assistance techniques. Assisted-as-needed control allows to create a force field along a desired trajectory, proportionally applying torque only when patient deviates from the pre-programmed correct pattern. This force field control, by assisting only the segments that the patient need, produces a natural gait pattern, improving the rehabilitation process.
| Study group | Role | What they receive |
|---|---|---|
| With knee exoskeleton | Experimental | The rehabilitation training will be focused on lower limb with specific activities for knee instability, and will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working).
Each session will be 45 minutes long. Three time per week, for three weeks.
The patients allocated in this arm will perform the training wearing the BELK device. Receives: Device: With knee exoskeleton |
| Without exoskeleton | No intervention | The rehabilitation training will be focused on lower limb with specific activities for knee instability, and will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working). Each session will be 45 minutes long. Three time per week, for three weeks. The patients allocated in this arm will perform the training without any exoskeleton. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking velocity
Walking velocity [m/s] will be calculated during walk test (10MWT). Markers positioned on the body will be tracked through a motion capture software and analyzed.
Measured: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Gait Profile Score
Gait Profile Score (GPS) is a useful index to analyze the gait performances. It is calculated starting from fifteen Gait Variable Score (GVS) which give a deeper view on the variables related to the locomotion trials.
Measured: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Secondary outcomes (10)
Change in 6-minute walking test (6MWT)
The six-minute walk test (6MWT) measures the distance, in meters, that an individual is able to walk over a total of six minutes on a hard, flat surface.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in joint force
Joint forces will be calculated as the amount of pressure recorded in newtons on the force plates during walking tests.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Surface electromyography (sEMG)
Surface electromyography (sEMG) is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles at rest (i.e., static) and during activity (i.e., dynamic). The procedure is performed using a single or an array of electrodes placed on the skin surface over the muscles to be tested. Recording can also be made using a hand-held device, which is applied to the skin surface at different sites. Electrical activity is assessed by computer analysis of the frequency spectrum, amplitude, or root-mean-square of the electrical action potential.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in energy cost of walking
Energy cost of walking, expressed in ml O2/kg/m will be measured using indirect calorimetry device
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Stair Climb Test (SCT)
The Stair Climb Test (SCT) measures, in seconds, the time taken by an individual to ascend and descend 10 steps (each step is 0.18 m in height).
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Timed Up and Go test (TUG)
The Timed "Up and Go" Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Short Form Survey Instrument (SF36)
Confidence levels will be calculated using the Short Form Survey Instrument (SF36). Items are scored using Likert scale and yes/no options. Scales are standardized with a scoring algorithm to obtain a score ranging from 0-100. High scores indicate better health status.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in International Knee Documentation Committee (IKDC) Questionnaire
The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Symptoms sub scale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity sub scale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function sub scale asks patients one simple question: how is their knee at present versus how was their knee prior to injury?
Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Knee Outcome Survey (KOS)
The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living sub scale) or sports (sports activity sub scale). The lower the percentage, the higher the disability.
This is a self-report measure that is broken down into two categories (ADLs and sport activities) that rates perceived disability with 5 being "no difficulty" and 0 being "unable to perform".[1]
Measured: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
System Usability Scale (SUS)
The scores on the System Usability Scale (SUS) was measured in order to assess the usability of BELK during rehabilitation training
Measured: Immediately after the rehabilitation training of experimental arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Jan 2021 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Why it stopped: pandemic of coronavirus disease
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InstabilityStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive a 6-week training program in a clinical setting in add-on to the standard neuro-rehabilitation treatment. The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Privata del Policlinico SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peppino Tropea, PhD, Principal investigator, Casa di Cura Privata del Policlinico SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173975
- Sponsor's protocol ID
- BELK@CCP
- Acronym
- BELK@CCP
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting
- ClinicalTrials.gov ID
- NCT04173975
- Acronym / sponsor ID
- BELK@CCP / BELK@CCP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: pandemic of coronavirus disease
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Casa di Cura Privata del Policlinico SpAUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 22 Nov 2019 (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.
This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion during ADL.
Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on to the standard neuro-rehabilitation treatment. Gait analysis and Instrumental Test will be performed every week till the end of the six-week training period while the Clinical Scales and Questionnaires will be performed after three weeks and at the end of the training period. Finally, additional outcome measures comprise the scores on the System Usability Scale (SUS) to evaluate the hardware and the Software Usability Measurement Inventory (SUMI) to evaluate the software of the BELK orthosis. These two measures will be administrated at the end of training with Belk orthosis, to rate patients' and operators' (e.g., physical therapist, medical doctors) satisfaction.
During 2018, the company GOGOA (www.gogoa.eu), specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a first prototype of the BELK system, a powered wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. As BELK is a wearable device, it can be used both, by the physiotherapist in the rehabilitation centers, improving the knee rehabilitation process and increasing patients' comfort, and accelerating their rehabilitation process.
Casa di Cura del Policlinico (CCP https://www.ccppdezza.it/en/) is a fully integrated multi-specialty clinical center aiming at providing both inpatient and outpatient services mainly directed to neurological patients. The Center is constituted as a Department of Neuro-rehabilitation Sciences, accredited by the Italian National Health System, and economically supported by Regione Lombardia. CCP offers to chronic neurological patients the highest comprehensive standards of care in a comfortable environment, through a multidisciplinary patient management approach organized around a core rehabilitation program.
Detailed description
The study design comprises a clinical study aimed at assessing efficacy of the BELK orthosis knee module on management of instability of the knee in 15 adults who have NMD or a CNS disorder. Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on at the standard neurorehabilitation treatment.
The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis. The activities will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working).
This clinical study will be a Randomized Control Trial (RCT) crossover longitudinal.
The clinical trial will be split in the following phases :
- Recruitment. Subjects admitted to CCP Neurorehabilitation unit will be recruited after considering inclusion and exclusion criteria through clinical history and medical visit.
- Randomization. Enrolled participants will be randomly allocated (per 2 blocked randomization lists, generated electronically by www.random.org) into the BELK assisted group (Group A) or the control group (Group B).
- Clinical, instrumental and questionnaires assessment at T0 (baseline)
- Rehabilitation Treatment (first block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group A will perform the training wearing the BELK device while patients allocated in Group B will perform the same exercise without any exoskeleton.
- Clinical, instrumental and questionnaires assessment at T1 (crossover)
- Rehabilitation Treatment (second block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group B will perform the training wearing the BELK device while patients allocated in Group A will perform the same exercise without any exoskeleton.
- Clinical, instrumental, questionnaires and usability assessment at T2 (final)
- Additional Instrumental Test will be performed after the first and the second week of each rehabilitation treatment block (i.e., T01, T02, T11, T12).
Instrumental Test consist of:
- Bio-mechanical performance (gait kinematics/kinetics analysis),
- Surface electromyography for knee functional evaluation (EMG),
- 6-minute walking test (6mWT),
- Baseline assessments uptake (VO2),
- Hearth rate (HR),
- Breathing frequency (BF),
- Timed Up and Go Test (TUG),
- Stair Climb Test (SCT).
Clinical scales consist of:
- Functional Independence Measure scale (FIM),
- Functional Ambulation category scale (FAC),
- lower-leg Ashworth scale (sum of score for hip, knee and ankle) (AS),
- Mini Balance Evaluation Systems Test (Mini-Best),
- Motricity Index (MI),
- Self-reported perceived effort (CR-10 Borg).
Questionnaires consist of:
- International Knee Documentation Committee subjective knee evaluation form (IKDC),
- Knee Outcome Survey Activity of Daily Living (KOS ADL) and health-related quality of life (SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive a 6-week training program in a clinical setting in add-on to the standard neuro-rehabilitation treatment. The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis.
| Arm | Type | Receives |
|---|---|---|
| With knee exoskeleton | Experimental | Device: With knee exoskeletonThe rehabilitation training will be focused on lower limb with specific activities for knee instability, and will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working). Each session will be 45 minutes long. Three time per week, for three weeks. The patients allocated in this arm will perform the training wearing the BELK device. |
| Without exoskeleton | No intervention | –The rehabilitation training will be focused on lower limb with specific activities for knee instability, and will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working). Each session will be 45 minutes long. Three time per week, for three weeks. The patients allocated in this arm will perform the training without any exoskeleton. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 30 - 85
- Sex: males and females
- Diagnosis of Neuromuscular diseases (NMD) or central nervous system (CNS) disorder with knee instability conditioning gait
- Functional Ambulation Categories (FAC) > 3
- Mini Mental State Examination (MMSE) > 24
Key exclusion criteria (7 listed)
- Bilateral impairment of the knees
- Knee implant
- Lower extremity amputation
- Severe sensorial impairment of the lower limbs
- Legal blindness or severe visual impairment
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 |
|---|---|---|
| With knee exoskeletonBELK is a wearable system that assists when and where the patient needs it intelligently through proper control of the system and optimized gait assistance techniques. Assisted-as-needed control allows to create a force field along a desired trajectory, proportionally applying torque only when patient deviates from the pre-programmed correct pattern. This force field control, by assisting only the segments that the patient need, produces a natural gait pattern, improving the rehabilitation process. | Device | With knee exoskeleton |
Primary outcome
Change in walking velocity
Time frame: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Walking velocity [m/s] will be calculated during walk test (10MWT). Markers positioned on the body will be tracked through a motion capture software and analyzed.
Change in Gait Profile Score
Time frame: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Gait Profile Score (GPS) is a useful index to analyze the gait performances. It is calculated starting from fifteen Gait Variable Score (GVS) which give a deeper view on the variables related to the locomotion trials.
10 secondary outcomes
Change in 6-minute walking test (6MWT)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in joint force
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Surface electromyography (sEMG)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in energy cost of walking
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Stair Climb Test (SCT)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Timed Up and Go test (TUG)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Short Form Survey Instrument (SF36)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in International Knee Documentation Committee (IKDC) Questionnaire
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Change in Knee Outcome Survey (KOS)
Time frame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
System Usability Scale (SUS)
Time frame: Immediately after the rehabilitation training of experimental arm.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- 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.
Peppino Tropea, PhD principal investigator
Casa di Cura Privata del Policlinico SpA
Questions about this trial
What is this clinical trial studying?
A study testing With knee exoskeleton in people with Knee Instability and Neuromuscular Diseases, run by Casa di Cura Privata del Policlinico SpA.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 walking velocity (time frame: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2022.