Muscle SpasticityPhase 2NCT02934646
Powered Exoskeleton for the Treatment of Elbow Spasticity
A Phase 2 study testing Robotic treatment in people with Muscle Spasticity and Stroke, run by Auxilium Vitae Volterra.
Trial summary
This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- Robotic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 2
- 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 79 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;
- Unability to keep sitting posture;
- Tendon retractions limiting upper limb joints range of motion.
About this study
Official title: Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study
This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.
Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- Robotic treatment
- Keywords
- Robotics, Upper Extremity
- 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.
Robotic treatmentDevice
Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device
| Study group | Role | What they receive |
|---|---|---|
| Subacute stroke patients | Experimental | Elbow passive/active robotic treatment provided by NEUROExos Elbow Module Receives: Device: Robotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Impairmente level maesure according to ICF
Measured: 2 weeks
Secondary outcomes (3)
Range of Motion
Impairmente level maesure according to ICF
Measured: 2 weeks
Maximum Extension Torque
Paramenter directly exterted by the device
Measured: 2 weeks
Zero-Torque Angle
Paramenter directly exterted by the device
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auxilium Vitae Volterra
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Toscana Nord Ovest, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934646
- Sponsor's protocol ID
- RN20161
- Status last verified
- Jul 2018
- First submitted
- 12 Oct 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study
- ClinicalTrials.gov ID
- NCT02934646
- Acronym / sponsor ID
- RN20161
- Conditions
- Muscle Spasticity, Stroke
- Keywords
- Robotics, Upper Extremity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Auxilium Vitae VolterraUniversity, hospital or other
- Collaborators
- Azienda USL Toscana Nord Ovest, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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 is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.
Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subacute stroke patients | Experimental | Device: Robotic treatmentElbow passive/active robotic treatment provided by NEUROExos Elbow Module |
Who may qualify
- Ages
- 18 to 79 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;
- Unability 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 |
|---|---|---|
| Robotic treatmentPassive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device | Device | Subacute stroke patients |
Primary outcome
Modified Ashworth Scale
Time frame: 2 weeks
Impairmente level maesure according to ICF
3 secondary outcomes
Range of Motion
Time frame: 2 weeks
Maximum Extension Torque
Time frame: 2 weeks
Zero-Torque Angle
Time frame: 2 weeks
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 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Muscle Spasticity
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Dystonic Cerebral Palsy
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robotic treatment in people with Muscle Spasticity and Stroke, run by Auxilium Vitae Volterra.
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: finished, as of the sponsor's last update on 26 Jul 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Modified Ashworth Scale (time frame: 2 weeks). 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 26 Jul 2018.