Efficacy of a Bilateral Robotic Treatment in Chronic Patients

Sponsor
University of Pisa
Study ID
NCT07259876
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bilateral robotic treatment for the upper limbs — DEVICE
    Patients will perform a specific sequence of exercises with the exoskeleton for the upper limbs ALEx-RS, including passive and active-assisted movements, unilateral and bilateral reaching tasks with visual feedback, and symmetric and asymmetric bimanual coordination tasks.
  • Standard physiotherapy — BEHAVIORAL
    After the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist.

Study Details

The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke. Researchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke. Participants will: * perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions * be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements

Key Dates

First listed
Dec 2, 2025
Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Left hemisphere lesion group
    The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
  • Experimental: Right hemisphere lesion group
    The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment

Primary Outcome Measure

Changes in the Fugl-Meyer for the upper limb functional scale (UEFM) [ Time Frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 ]

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