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

Federico Posteraro

Status: Completed

Conditions: Stroke

Treatments: Device: Robotic treatment - NESM alpha

Study type: Interventional

Funder types: Other

Identifiers

NCT07316218

PAR FAS 2007-2013 (Other Grant/Funding Number)

RONDA201813581

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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°

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

NESM-alpha

Experimental group

Description:

Patients with severe or moderate upper-limb motor impairment (UEFM ≤ 42) receive 7 sessions of robot-assisted shoulder-elbow mobilization (consecutive where possible, for a maximum of 5 sessions per week) in addition to standard rehabilitation. During the first and last session, the patients' residual capabilities are assessed though robotic-aided assessments as well as with clinical scales.

Treatment:

Device: Robotic treatment - NESM alpha