Stroke
Conditions
Keywords
Stroke, Pilot Study, Exoskeleton
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.
Interventions
DEVICERobotic treatment - NESM alpha
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.
Sponsors
Scuola Superiore Sant'Anna di Pisa
Federico Posteraro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Traditional feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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°
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 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 | Day 7 | Evaluate the number of patients that were recruited and retained for the full study period. Evaluate the number of drop-out. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Motor Function | 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. |
| Patient's Pain | 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). |
| Patient's functionality | 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. |
| Joint Torques | 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 |
| Joint Angles | Days 1 and 7 | Kinematic performance of the patient using the robot is assessed with the spanned joints angles (measured in degrees) |
| Patient's Spasticity | 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). |
Countries
Italy
Outcome results
None listed