Spasticity, Muscle, Stroke, Upper Limb
Conditions
Keywords
Robotics, Upper extremities, EMG
Brief 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. 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.
Interventions
DEVICENeuroexsos 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
Sponsors
Scuola Superiore Sant'Anna Pisa
Azienda USL Toscana Nord Ovest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Indipendent assessor blinded on treatment provided
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Unstable general clinical conditions; * Inability to keep sitting posture; * Tendon retractions limiting upper limb joints range of motion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better | 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 | Before and within 1 week after 4 weeks of treatment | It is a clinical scale for spasticity assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Extension Torque (MET) | Before and within 1 week after 4 weeks of treatment | It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle |
| Change in Zero Torque Angle (ZTA) | Before and within 1 week after 4 weeks of treatment | 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 |
| Change in Joint Impedance (JIMP) | Before and within 1 week after 4 weeks of treatment | 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). |
Countries
Italy
Outcome results
None listed