Spasticity, MuscleNCT04484571
Multimodal Instrumented Assessment of Post-stroke Elbow
A study testing Neuroexsos elbow module in people with Spasticity, Muscle and Stroke, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity, Muscle, Stroke, Upper Limb
- What is being tested?
- Neuroexsos elbow module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2020to 30 Jul 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper limb spasticity due to neurological impairment;
- Cognitive abilities sufficient for understanding instructions;
- Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).
Who cannot join
- Unstable general clinical conditions;
- Inability to keep sitting posture;
- Tendon retractions limiting upper limb joints range of motion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
Read the detailed description
The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy towards functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
- Conditions
- Spasticity, Muscle, Stroke, Upper Limb
- Being tested
- Neuroexsos elbow module
- Keywords
- Robotics, Upper extremities, EMG
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroexsos elbow moduleDevice
The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs
| Study group | Role | What they receive |
|---|---|---|
| Robotic treatment | Experimental | Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton Receives: Device: Neuroexsos elbow module |
| Conventional treatment | Active comparator | Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time Receives: Device: Neuroexsos elbow module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
It is a clinical scale used for the assessment of motor function in stroke patients
Measured: before and within 1 week after 4 weeks of treatment
Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse
It is a clinical scale for spasticity assessment
Measured: Before and within 1 week after 4 weeks of treatment
Secondary outcomes (3)
Change in Maximum Extension Torque (MET)
It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle
Measured: Before and within 1 week after 4 weeks of treatment
Change in Zero Torque Angle (ZTA)
It is the angular value corresponding to null torque exerted by the robot; in this configuration, flexor and extensor torques are equal and opposite and the system is ideally not applying any force to hold the elbow in position, which has reached its equilibrium point
Measured: Before and within 1 week after 4 weeks of treatment
Change in Joint Impedance (JIMP)
A measure of the limb resistance to muscle elongation, extracted as the ratio between joint torque and joint angular position for constant, slow-speed movements, the main contribution to the joint impedance can be identified in the joint stiffness (i.e. rigidity).
Measured: Before and within 1 week after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start6 Jul 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies 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
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore Sant'Anna Pisa
- Responsible party
- Principal investigator, Federico Posteraro, Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484571
- Sponsor's protocol ID
- NEEM20160118
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pilla A, Trigili E, McKinney Z, Fanciullacci C, Malasoma C, Posteraro F, Crea S, Vitiello N. Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol. Front Neurol. 2020 Oct 22;11:587293. doi: 10.3389/fneur.2020.587293. eCollection 2020.
PubMed 33193052
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04484571
- Acronym / sponsor ID
- NEEM20160118
- Conditions
- Spasticity, Muscle, Stroke, Upper Limb
- Keywords
- Robotics, Upper extremities, EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- Scuola Superiore Sant'Anna Pisa
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 23 Jul 2020 (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 proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
Detailed description
The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy towards functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Robotic treatment | Experimental | Device: Neuroexsos elbow modulePatients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton |
| Conventional treatment | Active comparator | Device: Neuroexsos elbow modulePatients receive 4 weeks of elbow conventional rehabilitation treatment matched in time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Upper limb spasticity due to neurological impairment;
- Cognitive abilities sufficient for understanding instructions;
- Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).
Key exclusion criteria (3 listed)
- Unstable general clinical conditions;
- Inability to keep sitting posture;
- Tendon retractions limiting upper limb joints range of motion.
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 |
|---|---|---|
| Neuroexsos elbow moduleThe treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs | Device | Conventional treatment, Robotic treatment |
Primary outcome
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
Time frame: before and within 1 week after 4 weeks of treatment
It is a clinical scale used for the assessment of motor function in stroke patients
Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse
Time frame: Before and within 1 week after 4 weeks of treatment
It is a clinical scale for spasticity assessment
3 secondary outcomes
Change in Maximum Extension Torque (MET)
Time frame: Before and within 1 week after 4 weeks of treatment
Change in Zero Torque Angle (ZTA)
Time frame: Before and within 1 week after 4 weeks of treatment
Change in Joint Impedance (JIMP)
Time frame: Before and within 1 week after 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 33193052Pilla A, Trigili E, McKinney Z, Fanciullacci C, Malasoma C, Posteraro F, Crea S, Vitiello N. Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol. Front Neurol. 2020 Oct 22;11:587293. doi: 10.3389/fneur.2020.587293. eCollection 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroexsos elbow module in people with Spasticity, Muscle and Stroke, run by Azienda USL Toscana Nord Ovest 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 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
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 score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better (time frame: before and within 1 week after 4 weeks of treatment). 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?
On the ClinicalTrials.gov record for NCT04484571, which also lists 1 linked publication.
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 25 Jul 2023.