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Completed

NCT Number: NCT07316218

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Versilia

Lido di Camaiore, Tuscany, 55041, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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°

Treatment and study plan

Robotic treatment - NESM alpha

Device

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.

Primary outcomes

  1. Number of adverse events

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

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

  2. Feasibility of recruitment and retention

    Time frame: Day 7

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

Secondary outcomes

  1. Patient's functionality

    Time frame: Days 1 and 7

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

  2. Patient's Spasticity

    Time frame: Days 1 and 7

    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).

  3. Patient's Motor Function

    Time frame: Days 1 and 7

    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.

  4. Patient's Pain

    Time frame: Days 1 and 7

    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).

  5. Joint Angles

    Time frame: Days 1 and 7

    Kinematic performance of the patient using the robot is assessed with the spanned joints angles (measured in degrees)

  6. Joint Torques

    Time frame: Days 1 and 7

    Kinematic performance of the patient using the robot is assessed with the joint torques (measured in Nm) exchanged with the robot

Sponsors and collaborators

Lead sponsor

Federico Posteraro

Other

Collaborators

  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Registry information

Acronym: RONDA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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