StrokeBILATNCT07145476
Bilateral Robotic Rehabilitation in Chronic Stroke
A study testing Robotic arm exoskeleton integrated with cognitively engaging serious games in people with Stroke, run by Carmelo Chisari at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic arm exoskeleton integrated with cognitively engaging serious games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2020to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-ever unilateral stroke event;
- upper limb paresis with the ability to perform at least antigravity movements of the upper limb;
- right- hand dominance.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for Patients With Chronic Stroke Outcomes
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.
Read more
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.
- Conditions
- Stroke
- Being tested
- Robotic arm exoskeleton integrated with cognitively engaging serious games
- Keywords
- Robotic, Neuroplasticity, Personalized Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic arm exoskeleton integrated with cognitively engaging serious gamesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RHS | Experimental | Right Hemisphere affected Receives: Device: Robotic arm exoskeleton integrated with cognitively engaging serious games |
| LHS | Experimental | Left Hemisphere affected Receives: Device: Robotic arm exoskeleton integrated with cognitively engaging serious games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post training
The Fugl-Meyer for the Upper Limb ranges from 0 to 66, with higher scores indicating better performance
Measured: 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
Changes in Motricity Index (MI) scale pre vs post training
The Motricity Index ranges from 0 to 100, with higher scores indicating better performance
Measured: 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
Changes in Bimanual Activity Test (BAT) scale pre vs post training
The Bimanual Activity Test ranges from 0 to 100, with higher scores indicating better performance
Measured: 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
Secondary outcomes (2)
Changes in movement smoothness pre vs post training
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
Measured: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0
Changes in movement duration pre vs post training
The duration of patients' movements during reaching tasks with the exoskeleton will be measured in seconds, with shorter durations indicating better performance
Measured: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start10 Sep 2020
- Primary completion10 Sep 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmelo Chisari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmelo Chisari, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145476
- Sponsor's protocol ID
- 17605
- Acronym
- BILAT
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for Patients With Chronic Stroke Outcomes
- ClinicalTrials.gov ID
- NCT07145476
- Acronym / sponsor ID
- BILAT / 17605
- Conditions
- Stroke
- Keywords
- Robotic, Neuroplasticity, Personalized Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Carmelo ChisariUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHS | Experimental | Device: Robotic arm exoskeleton integrated with cognitively engaging serious gamesRight Hemisphere affected |
| LHS | Experimental | Device: Robotic arm exoskeleton integrated with cognitively engaging serious gamesLeft Hemisphere affected |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first-ever unilateral stroke event;
- upper limb paresis with the ability to perform at least antigravity movements of the upper limb;
- right- hand dominance.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic arm exoskeleton integrated with cognitively engaging serious gamesA 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. | Device | LHS, RHS |
Primary outcome
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
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic arm exoskeleton integrated with cognitively engaging serious games in people with Stroke, run by Carmelo Chisari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.