Clinical trial NCT04484571: Multimodal Instrumented Assessment of Post-stroke Elbow
Official title: Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spasticity, Muscle
Stroke
Upper Limb
Keywords: Robotics
Upper extremities
EMG
Lead sponsor: Azienda USL Toscana Nord Ovest
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna Pisa
First posted: 2020-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
timeFrame: before and within 1 week after 4 weeks of treatment
measure: Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse
timeFrame: Before and within 1 week after 4 weeks of treatment
Secondary outcomes:
measure: Change in Maximum Extension Torque (MET)
timeFrame: Before and within 1 week after 4 weeks of treatment
measure: Change in Zero Torque Angle (ZTA)
timeFrame: Before and within 1 week after 4 weeks of treatment
measure: Change in Joint Impedance (JIMP)
timeFrame: Before and within 1 week after 4 weeks of treatment
Other outcomes:
Locations:
city: Camaiore
country: Italy
facility: Ospedale Versilia
state: Lucca
Study officials:
References:
citation: 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.