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Completed

NCT Number: NCT07145476

Bilateral Robotic Rehabilitation in Chronic Stroke

This study investigated the effectiveness and neurophysiological correlates of Bilateral Robot-Assisted Training (BRAT) in right-handed individuals with chronic unilateral stroke, focusing on how lesion side (dominant vs. non-dominant hemisphere) influences recovery. Twenty-four participants (>6 months post-stroke) completed a three-week BRAT program using the ALEx-RS robotic exoskeleton integrated with cognitively engaging serious games involving symmetric and asymmetric upper limb tasks.

Clinical outcomes (Fugl-Meyer Assessment, Bimanual Activity Test, Motricity Index) and kinematic measures (movement smoothness, movement duration) were assessed at baseline, post-treatment, and at two-month follow-up. Significant improvements (p < 0.05) in all outcomes were observed after training and maintained at follow-up.

Patients with left hemiparesis (non-dominant side affected) showed greater gains in movement smoothness and bimanual task quality, suggesting recovery of more physiological motor patterns. Conversely, those with right hemiparesis (dominant side affected) improved mainly in movement speed, indicating compensatory strategy use. Greater baseline impairment predicted larger kinematic gains, particularly in the left hemiparesis group.

These findings support BRAT as an effective intervention for chronic stroke and underscore the importance of lesion side in shaping recovery profiles, with implications for personalized rehabilitation planning.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUP

Pisa, 56124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first-ever unilateral stroke event;
  • upper limb paresis with the ability to perform at least antigravity movements of the upper limb;
  • right- hand dominance.

Exclusion criteria

  • impossibility to provide informed consent;
  • cognitive impairment limiting the ability to understand the therapist's directions (screening Mini-Mental State Examination score <24/30);
  • hemispatial neglect, severe memory/attention impairment or severe aphasia;
  • degree of spasticity of the upper limb such as to make the use of robotic devices impossible (Modified Ashworth Scale score > 3).

Treatment and study plan

Robotic arm exoskeleton integrated with cognitively engaging serious games

Device

A specific sequence of exercises including passive and active- assisted movements, unilateral and bilateral reaching tasks with visual feedback and bimanual symmetric and asymmetric coordination tasks.

Primary outcomes

  1. Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post training

    Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

    The Fugl-Meyer for the Upper Limb ranges from 0 to 66, with higher scores indicating better performance

  2. Changes in Motricity Index (MI) scale pre vs post training

    Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

    The Motricity Index ranges from 0 to 100, with higher scores indicating better performance

  3. Changes in Bimanual Activity Test (BAT) scale pre vs post training

    Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

    The Bimanual Activity Test ranges from 0 to 100, with higher scores indicating better performance

Secondary outcomes

  1. Changes in movement smoothness pre vs post training

    Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0

    The smoothness of patients' movements during reaching tasks with the exoskeleton will be measured using the modified Spectral ARC length (SPARC), with higher scores indicating better performance

  2. Changes in movement duration pre vs post training

    Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0

    The duration of patients' movements during reaching tasks with the exoskeleton will be measured in seconds, with shorter durations indicating better performance

Sponsors and collaborators

Lead sponsor

Carmelo Chisari

Other

Registry information

Official study title

Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for Patients With Chronic Stroke Outcomes

Acronym: BILAT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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