Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke

Condition(s) studied

Investigational drug(s) / intervention(s)

Technology-based UL rehabilitation: Participants will receive conventional treatments, including neuromotor, occupational therapy, speech therapy and/or neuropsychology treatments, as clinically indicated. In addition, they will undergo a personalized and specific UL technology-based rehabilitation programme, delivered 3 times per week, for a total of 12 - 15 sessions. Each session will last 1 hour and will be conducted in a 1:1 format (physiotherapist : participant). Data on rehabilitation dosage will be collected, including the total number of hours of rehabilitation received. Physiotherapists who will have in charge participant, will compiled a treatment diary for each technology session in which they will record: number of session, total hour of technology-based treatments, type of device used and any adverse events.

Study summary

This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period.

The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments.

Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.

Eligibility

Primary outcome measure(s)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) — Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
  Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is an ordinal scale used to assess sensorimotor function following stroke. The upper extremity motor function section includes four subscales assessing synergistic and non-synergistic movements of shoulder, elbow, wrist and hand, as well as coordination/speed. The maximum score is 66 points, indicating normal upper limb motor function. In addition to motor function, the FMA-UE assesses Non-motor domains (i.e., sensation, passive joint movement and pain), with a maximum total score of 60 points.
• Action Research Arm Test (ARAT) — Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
  Action Research Arm Test (ARAT) consists of 19 items grouped in subtests (i.e., grasp, grip, pinch, and gross arm movement) and performance of each item rated on a 4 points scale (from 0 - no movement possible, to 3 - movement performed normally.

Trial sites (1)

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