Multimodal Instrumented Assessment of Post-stroke Elbow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

NCT04697368

Stroke Upper Extremity Paresis

ACTIVE_NOT_RECRUITING NA

Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients

NCT01102309

Stroke Cerebrovascular Accident Upper Extremity Paresis

COMPLETED NA

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

NCT03104881

Stroke

COMPLETED NA

Effects of Robotic Rehabilitation in Post-Stroke Patients

NCT04494685

Stroke

UNKNOWN NA

Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients

NCT03319992

Cerebrovascular Accident (CVA) Chronic Disease Stroke Rehabilitation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Spasticity, Muscle Stroke Upper Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Indipendent assessor blinded on treatment provided

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic treatment

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

Group Type EXPERIMENTAL

Neuroexsos elbow module

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Neuroexsos elbow module

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).