NCT04484571

Multimodal Instrumented Assessment of Post-stroke Elbow

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Azienda USL Toscana Nord Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity, Muscle
• Stroke
• Upper Limb

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-06
• Primary completion: 2024-05-30
• Completion: 2024-07-30
• First posted: 2020-07-23
• Last updated: 2023-07-25

Locations

1 site across 1 country: Italy