StrokeSCORESNCT06109324
Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)
A study testing Robotic Rehabilitation of the upper limb and Conventional Rehabilitation of the upper limb in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial summary
Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Rehabilitation of the upper limb and Conventional Rehabilitation of the upper limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesItaly
- Study dates
- 13 Nov 2023to Jan 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a single event, verified by MRI or CT;
- age between 18 and 85 years;
- time since stroke within six months;
- a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23
Who cannot join
- behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy;
- fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
- severe deficits in visual acuity.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi
Florence, 50143
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98123
- Recruiting
Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
Roma, 00166
About this study
Official title: A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study.
Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify significant differences in motor-related outcomes between the two approaches.
In addition to motor deficits, stroke survivors often experience cognitive decline and sensory disturbances, which can significantly impede their recovery process. The introduction of multisensory stimulation and an enriched environment through robotic interventions may offer valuable supplementary treatments in these specific areas. Nevertheless, this aspect of treatment has not been thoroughly explored.
This study seeks to assess the effectiveness of upper limb robotic rehabilitation in individuals recovering from subacute strokes, in comparison to conventional treatments. Specifically, it aims to determine whether this robotic therapy can lead to improvements in (a) cognitive deficits, (b) somatosensory impairment, and (c) how these sensory and cognitive deficits influence the process of motor recovery.
Read the detailed description
The study aims to investigate whether an upper limb robotic treatment could have a greater impact than a conventional approach on specific cognitive domains in patients with stroke, as well as in restoring the somatosensory impairment in patients with stroke.
For this aim, 126 consecutive subjects with stroke in the sub-acute phase (within 6 months after stroke) will be enrolled and randomized to either the robotic (RG) or the conventional group (CG). The sample size was calculated by means of a 2- sided, 2-sample t-test assuming: 80% power; type I error of 0.05; a mean difference of 2.15 units on the MoCA, a common standard deviation of 3.77 points (Wu 2019). Considering a dropout rate of 20%, the final sample size required was estimated to be 126 subjects.
Randomization will be stratified according to a cut-off of 18.28 on the MoCA demographically adjusted total score (inner confidence limit of the 5th centile of the normal population) indicating a borderline performance, to ensure that the subjects' characteristics in each group will be closely matched. In the RG, patients will undergo robotic therapy, while a conventional approach will be used in the CG. The rehabilitation treatments, either robotic or conventional, will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. Patients in the RG will be treated using a set of devices that allow bi- and three-dimensional movements of the shoulder, elbow, wrist, and fingers (Aprile et al, 2019). Motor and cognitive tasks, carefully selected among those available, will be performed during the treatment, following a protocol already proposed in a previous pilot study (Aprile et al, 2021). Visual and auditory feedback will be provided to help the patients. In the RG, treatment will focus on reprogramming sensorimotor function, hypertonus inhibition, and functional improvement. Patients will be evaluated at baseline (T0), the end of the rehabilitation protocol (T1), and a 6-month follow-up (T2).
- Conditions
- Stroke
- Being tested
- Robotic Rehabilitation of the upper limb, Conventional Rehabilitation of the upper limb
- Keywords
- robotics, cognition, rehabilitation, upper extremity, sensorimotor
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Rehabilitation of the upper limbOther
Upper limb rehabilitation using a set of 4 devices. A set of motor/cognitive exercises will be selected to train also attention, memory, executive function, speed of processing, and visuospatial abilities.The following devices will be used: (a) a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints (Motore, Humanware); (b) a robotic device that allows passive, active, and active-assistive finger flexion and extension movements (Amadeo, Tyromotion); (c) a sensor-based system that allows unsupported 3-dimensional movements of shoulder, elbow, and wrist joint, both unimanual and bimanual (Pablo, Tyromotion); and (d) a robotic system that allows 3-dimensional, unimanual and bimanual, movements of the shoulder joint, with arm weight support (Diego, Tyromotion).
The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.
Conventional Rehabilitation of the upper limbOther
Upper limb rehabilitation using conventional techniques, focused on upper limb reprogramming sensorimotor function, hypertonus, inhibition and functional improvement.
The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Rehabilitation | Experimental | Not described Receives: Other: Robotic Rehabilitation of the upper limb |
| Conventional treatment | Active comparator | Not described Receives: Other: Conventional Rehabilitation of the upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Montreal Cognitive Assessment
It is a validated test of cognitive impairment. It ranges from 0 (indicating worse cognitive function) to 30 (best cognitive function).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention
Secondary outcomes (17)
Changes in Montreal Cognitive Assessment
It is a validated test of cognitive impairment. It ranges from 0 (indicating worse cognitive function) to 30 (best cognitive function).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Symbol Digit Modalities Test
The Symbol Digit Modalities Test evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used.
For each correct answer, a point is assigned.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Tower of London
The Tower of London test is a tool to assess strategic decision and problem solving. The patient is required to move different colored balls on the three pegs of different lengths, according to a model and a number of established moves. The maximum time for each configuration is 60 seconds.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Rey-Osterrieth Complex Figure test
The Rey-Osterrieth Complex Figure is a neuropsychological assessment for evaluation of visuospatial abilities, memory, attention, planning, working memory and executive functions. The patient is required to copy a complex figure freehand (recognition), and then draw it from memory (recall). The score is assigned based on the correctness of each line (from 0 to 2)
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Visual search test
It is a validated measure of visual attention.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (motor score)
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Thumb Localizing Test
It is a standardised measure of proprioception. It ranges from 0 (normal) to 3.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Semmes Weinstein filament test
It measure the level of light touch sensation of the tips of the thumb and index finger. The Semmes Weinstein filament test kit consists of 20 flexible nylon monofilaments of constant length, but varying in diameter. They are labeled so as to give a linear scale of perceived intensity (1.65-6.65) using a logarithmic scale of applied force: labeled number = Log10 of (10 × force in milligrams). The more the labeled number increases, the thicker the filament becomes, and the more pressure is necessary to bend the filament.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (sensation score)
It is a stroke-specific, performance-based impairment index. It ranges from 0 (no sensation) to 12 points (normal).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Box and Block test
The Box and Block test is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Motricity Index
It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Modified Barthel Index
The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Numerical Rating Scale for Pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Neuropathic Pain Symptom Inventory
It is a validated scale for evaluating both peripheral and central neuropathic pain. It ranges from 0 to 100 (most imaginable pain)
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Douleur Neuropathique 4
It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Post-stroke Depression Rating Scale
It is a validated measure of depression in post-stroke patients. The score ranges from 0 (best) to 45 (worse)
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Intrinsic Motivation Inventory
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement method designed to assess participants' subjective experience related to a target activity in laboratory experiments
Measured: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start13 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionJan 2026 (estimated)
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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
- Investigators
- Marco Germanotta, PhD, Study director, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109324
- Sponsor's protocol ID
- SCORES_clinicalstudy
- Acronym
- SCORES
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study.
- ClinicalTrials.gov ID
- NCT06109324
- Acronym / sponsor ID
- SCORES / SCORES_clinicalstudy
- Conditions
- Stroke
- Keywords
- robotics, cognition, rehabilitation, upper extremity, sensorimotor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 31 Oct 2023 (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.
Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify significant differences in motor-related outcomes between the two approaches.
In addition to motor deficits, stroke survivors often experience cognitive decline and sensory disturbances, which can significantly impede their recovery process. The introduction of multisensory stimulation and an enriched environment through robotic interventions may offer valuable supplementary treatments in these specific areas. Nevertheless, this aspect of treatment has not been thoroughly explored.
This study seeks to assess the effectiveness of upper limb robotic rehabilitation in individuals recovering from subacute strokes, in comparison to conventional treatments. Specifically, it aims to determine whether this robotic therapy can lead to improvements in (a) cognitive deficits, (b) somatosensory impairment, and (c) how these sensory and cognitive deficits influence the process of motor recovery.
Detailed description
The study aims to investigate whether an upper limb robotic treatment could have a greater impact than a conventional approach on specific cognitive domains in patients with stroke, as well as in restoring the somatosensory impairment in patients with stroke.
For this aim, 126 consecutive subjects with stroke in the sub-acute phase (within 6 months after stroke) will be enrolled and randomized to either the robotic (RG) or the conventional group (CG). The sample size was calculated by means of a 2- sided, 2-sample t-test assuming: 80% power; type I error of 0.05; a mean difference of 2.15 units on the MoCA, a common standard deviation of 3.77 points (Wu 2019). Considering a dropout rate of 20%, the final sample size required was estimated to be 126 subjects.
Randomization will be stratified according to a cut-off of 18.28 on the MoCA demographically adjusted total score (inner confidence limit of the 5th centile of the normal population) indicating a borderline performance, to ensure that the subjects' characteristics in each group will be closely matched. In the RG, patients will undergo robotic therapy, while a conventional approach will be used in the CG. The rehabilitation treatments, either robotic or conventional, will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. Patients in the RG will be treated using a set of devices that allow bi- and three-dimensional movements of the shoulder, elbow, wrist, and fingers (Aprile et al, 2019). Motor and cognitive tasks, carefully selected among those available, will be performed during the treatment, following a protocol already proposed in a previous pilot study (Aprile et al, 2021). Visual and auditory feedback will be provided to help the patients. In the RG, treatment will focus on reprogramming sensorimotor function, hypertonus inhibition, and functional improvement. Patients will be evaluated at baseline (T0), the end of the rehabilitation protocol (T1), and a 6-month follow-up (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Rehabilitation | Experimental | Other: Robotic Rehabilitation of the upper limb |
| Conventional treatment | Active comparator | Other: Conventional Rehabilitation of the upper limb |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a single event, verified by MRI or CT;
- age between 18 and 85 years;
- time since stroke within six months;
- a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23
Key exclusion criteria (3 listed)
- behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy;
- fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
- severe deficits in visual acuity.
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 Rehabilitation of the upper limbUpper limb rehabilitation using a set of 4 devices. A set of motor/cognitive exercises will be selected to train also attention, memory, executive function, speed of processing, and visuospatial abilities.The following devices will be used: (a) a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints (Motore, Humanware); (b) a robotic device that allows passive, active, and active-assistive finger flexion and extension movements (Amadeo, Tyromotion); (c) a sensor-based system that allows unsupported 3-dimensional movements of shoulder, elbow, and wrist joint, both unimanual and bimanual (Pablo, Tyromotion); and (d) a robotic system that allows 3-dimensional, unimanual and bimanual, movements of the shoulder joint, with arm weight support (Diego, Tyromotion). The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. | Other | Robotic Rehabilitation |
| Conventional Rehabilitation of the upper limbUpper limb rehabilitation using conventional techniques, focused on upper limb reprogramming sensorimotor function, hypertonus, inhibition and functional improvement. The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. | Other | Conventional treatment |
Primary outcome
Changes in Montreal Cognitive Assessment
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention
It is a validated test of cognitive impairment. It ranges from 0 (indicating worse cognitive function) to 30 (best cognitive function).
17 secondary outcomes
Changes in Montreal Cognitive Assessment
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Symbol Digit Modalities Test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Tower of London
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Rey-Osterrieth Complex Figure test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Visual search test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (motor score)
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Thumb Localizing Test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Semmes Weinstein filament test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (sensation score)
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Box and Block test
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Motricity Index
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Modified Barthel Index
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Numerical Rating Scale for Pain
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Neuropathic Pain Symptom Inventory
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Douleur Neuropathique 4
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Post-stroke Depression Rating Scale
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Intrinsic Motivation Inventory
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
Marco Germanotta, PhD study director
IRCCS Fondazione Don Carlo Gnocchi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Rehabilitation of the upper limb and Conventional Rehabilitation of the upper limb in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 3 sites 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Germanotta, PhD (+390633086553, mgermanotta@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Montreal Cognitive Assessment (time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention). 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 15 Oct 2024.