Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.

Federico Posteraro7 enrolled

Overview

The study is designed as an open-label pilot study with a pre-post treatment assessment.

The enrolled patients will undergo a rehabilitation program aimed at recovering upper-limb motor function. The entire cohort will receive the hospital's standard rehabilitative care, and the experimental treatment will be provided as an add-on. All participants will complete 7 sessions of robot-assisted rehabilitation (consecutive where possible, for a maximum of 5 sessions per week), with the NESM-α robotic exoskeleton. Robotic treatment consists of sessions focused on shoulder and elbow mobilization and functional movements. The range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Robotic treatment - NESM alphaDEVICE

The NESM-α exoskeleton can deliver passive mobilization or active-assist support that follows the patient's voluntary motion. The joints' range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unilateral ischemic or hemorrhagic stroke, sub-acute (\<6 months) or chronic (\>6 months) * Severe spasticity (MAS ≥ 2) or mild-moderate spasticity with residual active antigravity movements (MAS \< 2) * Fugl-Meyer upper extremity score ≤ 42 * MMSE \> 24 * No severe pain during passive mobilization * Written informed consent Exclusion Criteria: * Unstable clinical conditions * Inability to maintain sitting posture * Pacemaker or other implanted electronic devices * Passive range of motion \< 10°

Locations (1)

Ospedale Versilia

Lido di Camaiore, Tuscany, Italy

Outcomes

Primary Outcomes

Number of adverse events

Safety of the delivered treatment is assessed monitoring the number of Adverse Events (AE). The metric is the number of events.

Time frame: from enrollment to the end of treatment (up to 2 weeks)

Feasibility of recruitment and retention

Evaluate the number of patients that were recruited and retained for the full study period. Evaluate the number of drop-out.

Time frame: Day 7

Secondary Outcomes

Patient's functionality

Patient's functionality is assessed with Fugl-Meyer Assessment. It ranges from 0-66 with 0 indicating no funcionality, and 66 normal motor function.

Time frame: Days 1 and 7

Patient's Spasticity

Patient's spasticity is assessed with the Modified Ashworth Scale (MAS). It rates spasticity (muscle tone) during passive stretch. Range: 0, 1, 1+, 2, 3, 4. Direction: 0 = no increase in tone (best); 4 = rigid in flexion/extension (worst).

Time frame: Days 1 and 7

Patient's Motor Function

Patient's motor function is assessed with the Wolf Motor Function Test (WMFT). It assesses upper-limb motor function via 15 timed tasks plus strength measures. Performance Time: seconds to complete each task (often capped at 120 s if not completed). Lower = better.

Time frame: Days 1 and 7

Patient's Pain

Patient's pain is assessed with the Numeric Pain Rating Scale (NPRS). Range: 0-10 (integer or 0.5 steps). Direction: 0 = no pain (best); 10 = worst imaginable pain (worst).

Time frame: Days 1 and 7

Data from ClinicalTrials.gov

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