An interventional study of Neuroexsos elbow module in Spasticity, Muscle, Stroke and Upper Limb, sponsored by Azienda USL Toscana Nord Ovest. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Azienda USL Toscana Nord Ovest · Not applicable, Interventional, and Treatment
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.
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Azienda USL Toscana Nord Ovest is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton
Device: Neuroexsos elbow module
Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time
Device: Neuroexsos elbow module
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
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
Time frame: 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
Time frame: Before and within 1 week after 4 weeks of treatment
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
Time frame: 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
Time frame: 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).
Time frame: Before and within 1 week after 4 weeks of treatment
Plan to share: No
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Azienda USL Toscana Nord Ovest