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Not yet recruiting NCT07259876

Efficacy of a Bilateral Robotic Treatment in Chronic Patients

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bilateral robotic treatment for the upper limbs, Standard physiotherapy.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes

Overview

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

Interventions

  • Device Bilateral robotic treatment for the upper limbs
    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.
  • Behavioral Standard physiotherapy
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Changes in the Bimanual Activity Test scale (BAT) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in the modified Ashworth scale (MAS) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in the Stroke Impact Scale (SIS) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in the Visual Analogue Scale (VAS) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in the Quick Dash scale [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in muscular synergies (EMG) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]
  • Changes in kinematic movement smoothness (SPARC) [Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0]

Eligibility criteria

Inclusion criteria

  • Subjects aged between 18 and 80 years, of either sex
  • Subjects able to understand and provide, or have provided on their behalf, informed consent
  • History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (> 6 months)
  • Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)

Exclusion criteria

  • Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education < 24/30)
  • Subjects with severe visual deficits
  • Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale > 3)
  • Inability or unwillingness to provide informed consent
  • Left-handed subjects

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07259876 · 0017901/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗