Multimodal Instrumented Assessment of Post-stroke Elbow

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04484571
• Other study ID #: NEEM20160118
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: July 2023
• Source: Azienda USL Toscana Nord Ovest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle
• Stroke
• Upper Limb

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Versilia	Camaiore	Lucca

Sponsors (2)

Lead Sponsor	Collaborator
Azienda USL Toscana Nord Ovest	Scuola Superiore Sant'Anna Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	before and within 1 week after 4 weeks of treatment
Primary	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	Before and within 1 week after 4 weeks of treatment
Secondary	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	Before and within 1 week after 4 weeks of treatment
Secondary	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	Before and within 1 week after 4 weeks of treatment
Secondary	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).	Before and within 1 week after 4 weeks of treatment