Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Indipendent assessor blinded on treatment provided
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
Time Frame: 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
Time Frame: Before and within 1 week after 4 weeks of treatment
It is a clinical scale for spasticity assessment
Secondary Outcomes
- Change in Maximum Extension Torque (MET)(Before and within 1 week after 4 weeks of treatment)
- Change in Zero Torque Angle (ZTA)(Before and within 1 week after 4 weeks of treatment)
- Change in Joint Impedance (JIMP)(Before and within 1 week after 4 weeks of treatment)
Investigators
Federico Posteraro
Head of North Area Rehabilitation Department
Azienda USL Toscana Nord Ovest