Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Number of adverse events
Study Overview
Brief Summary
The study is designed as an open-label pilot study with a pre-post treatment assessment.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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°
Arms & Interventions
NESM-alpha
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.
Intervention: Robotic treatment - NESM alpha (Device)
Outcomes
Primary Outcomes
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.
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
- Joint Angles(Days 1 and 7)
- Patient's functionality(Days 1 and 7)
- Patient's Spasticity(Days 1 and 7)
- Patient's Motor Function(Days 1 and 7)
- Patient's Pain(Days 1 and 7)
- Joint Torques(Days 1 and 7)
Investigators
Federico Posteraro
Head of Rehabilitation Department
Azienda USL Toscana Nord Ovest