Multimodal Instrumented Assessment of Post-stroke Elbow

NCT04484571 | Unknown DMC

• 1 other identifier: NEEM20160118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity, Muscle; Stroke; Upper Limb

Keywords

Robotics; Upper extremities; EMG

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

Study Arms (2)

Robotic treatment

EXPERIMENTAL

Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton

Device: Neuroexsos elbow module

Conventional treatment

ACTIVE COMPARATOR

Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time

Device: Neuroexsos elbow module

Interventions

Neuroexsos elbow module DEVICE

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

Conventional treatment; Robotic treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Unstable general clinical conditions;
• Inability to keep sitting posture;
• Tendon retractions limiting upper limb joints range of motion.

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead
• Scuola Superiore Sant'Anna Pisa: collaborator

Study Sites (1)

Ospedale Versilia

Camaiore, Lucca, 55041, Italy

Location

Related Publications (1)

• 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.

  PMID: 33193052 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Indipendent assessor blinded on treatment provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of North Area Rehabilitation Department

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 23, 2020
• Study Start: July 6, 2020
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)