Post-strokeNCT06009770
Telerehabilitation Protocols With Digital and Robotic Tools for People With Chronic Neurological Disorders
A study testing medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel) in people with Post-stroke and Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Post-stroke, Parkinson Disease, Multiple Sclerosis
- What is being tested?
- medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jan 2025
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic post-stroke condition with ischemic or haemorrhagic stroke injury occurred 4-6months before recruitment and with motor impairment of the upper limb > 2 to the Medical Research Council scale (MRC); or diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004); or diagnosis of MS, RR-SP forms, according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) < 6;
- age between 25 and 85 years;
- preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test >17.36) (Conti et al., 2015);
- agreement to participate with the signature of the informed consent form;
- no rehabilitation program in place at the time of enrolment;
- stable drug treatment (last 3 months) with L-Dopa or dopamine agonists (PD group) and/or cortisone (MS group).
Who cannot join
- presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
- presence of major psychiatric complications or personality disorders;
- presence of severe impairment of visual and/or acoustic perception;
- relapse ongoing/at least 3 months since the last relapse (MS group);
- presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
- falls resulting in injuries or a number of falls ≤ 2 in the 6 months prior to recruitment (PD and MS groups).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Implementation of Telerehabilitation Protocols With Digital and Robotic Tools for the Continuity of Care of People With Chronic Neurological Disorders - TELENEURO@REHAB"
The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). The main questions it aims to answer are 1)the usability and acceptability of the system; 2)the level of safety of intervention; 3) the efficacy of the telerehabilitation protocol. Participants will be randomized (with an allocation ratio of 1:1) into either the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 motor rehabilitation sessions performed at home according to the usual care treatment procedure). Researchers will compare the experimental group and the active control group to see if the TR protocol with digital and robotic tools is effective in reducing the perceived level of disability.
- Conditions
- Post-stroke, Parkinson Disease, Multiple Sclerosis
- Being tested
- medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel), Usual Care
- Keywords
- Telerehabilitation, Digital medicine, Robotics, Chronic Neurological conditions
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel)Device
Rehabilitation activities for PD and MS will be aimed at improving motor performance and balance using a task-oriented approach with Homing system technology; post-stroke patients will perform a home-based upper limb rehabilitation with the iCONE robotic device for robot-assisted neurorehabilitation of the upper limb.
Usual CareBehavioural
Standard motor exercise training aimed at muscle mobilization and strengthening (MS and PD groups) or to mobilize and enhance motor control of upper limb functions (post-stroke group)
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | The TR intervention for people with PD, MS, and people post-stroke will be focused on addressing impairments and functional limitations that affect activities and participation in everyday life.
1. Frequency: 5 weeks (4 sessions/week) of TR intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous, in-clinic session/week);
2. Intensity: customized according to the patient's functional abilities (system's feedback);
3. Time: 50 minutes/session;
4. Type: according to the disease, TR protocols with a digital system (for MS and PD) or robotic tool (for post-stroke). Receives: Device: medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel) |
| Usual Care | Active comparator | Conventional rehabilitation exercises at home, customized according to the disease. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0, Federici et al., 2017)
WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Secondary outcomes (14)
Change in global cognitive functioning as measured by the Montreal Cognitive Assessment (MoCA test, Conti et al., 2015) in PD, MS, and post-stroke groups
The MoCA test is a screening battery which also includes subtests to assess frontal functions such as set-shifting, abstraction and cognitive flexibility (MoCA total score range: 0-30). High scores are indicative of better general cognitive performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the Trail Making Test (TMT part A and B, Giovagnoli et al., 1996) in PD, MS, and post-stroke groups
The TMT is a neuropsychological test that involves visual scanning (TMT-A) and dual-task (TMT-B). The TMT is scored by how long it takes to complete each part of the test. High execution times indicate poor performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the and the Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006) in PD, MS, and post-stroke groups
The SDMT is a commonly used test to assess psychomotor speed. This paper-pencil measure involves a substitution task using a coding key with nine different abstract symbols, each paired with a numeral. Below the key, a series of these symbols is presented, and the participant is asked to write down the corresponding number for each symbol. The score consists of the number of correct substitutions within 90 seconds. Higher scores indicate better performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in depressive symptoms as measured by the Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999) in PD, MS, and post-stroke groups
The BDI-PC is a 7-item questionnaire with each item rated on a 4-point scale (0-3). It is scored by summing ratings for each item (range 0-21). Higher scores indicate greater deflection of mood tone.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in anxiety level as measured by the State-Trait Anxiety Inventory - Form Y (STAI - Y2; Spielberger, 1983; Pedrabissi & Santinello, 1989) in PD, MS, and post-stroke groups
The STAI-Y is a commonly used measure of trait and state anxiety (20 items for each). All items are rated on a 4-point scale (from "Almost Never" to "Almost Always"). STAI - Y2 is scored by summing ratings for each item (State-Anxiety: range 0-80; Trait Anxiety: range 0-80). Higher scores indicate greater anxiety.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in gross manual dexterity as measured by the Box and Block Test (BBT; Desrosiers et al., 1994) in PD, MS, and post-stroke groups
The BBT is composed of a wooden box divided into two compartments, one of which contains 150 blocks. The BBT administration consists of asking the patient to move, one by one, the maximum number of blocks from one compartment to another within 60 seconds. The score is based on the number of blocks transferred from one compartment to the other in 60 seconds. Higher scores are indicative of better manual dexterity.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in finger dexterity as measured by the Nine Hole Peg Test (Feys et al., 2017) in PD and MS groups
Participants are asked to take 9 pegs from a container, one by one, and place them into the 9 holes on the board of the test, as quickly as possible, using only the hand evaluated. The scoring considers the number of seconds taken by patients to complete the test or the number of pegs placed in 50 or 100 seconds. High execution times indicate poor finger dexterity.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in dynamic balance as measured by the modified Dynamic Gait Index (mDGI; Anastasi et al., 2019) in PD and MS groups
the mDGI measures the capacity to adapt gait to complex tasks utilizing 8 tasks and 3 facets of performance (gait pattern score [0 -3], level of assistance [0 -2], and time level score [0 -3]). The total task score (range 0 - 8) is calculated by summing the 3 performance facet scores for each task. Higher scores are indicative of better performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in static and dynamic balance as measured by the Mini-Best Test (Franchignoni et al., 2010) in PD and MS groups
The Mini-BESTest aims to identify the disordered systems underlying the postural control responsible for poor functional balance. This tool is composed by 27 tasks (36 items in total) assessing bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. Each item is scored based on ordinal scale scoring from 0- 3 where 3 = best performances and 0 = worst performances. The total score is provided as a percentage. Higher scores are indicative of better performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale (ABC; Cattaneo et al., 2006; Franchignoni et al., 2014) in PD and MS groups
ABC is a 16-item questionnaire that measures an individual's confidence during activities without falling or experiencing a sense of unsteadiness. Each item is scored ranging from 0 to 100. Higher scores are indicative of higher perceived stability.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in motor functionality as measured by the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS; Goetz et al., 2008) part III only in the PD group
MDS-UPDRS assess changes in motor functionality. Part III (''motor examination") is composed of 18 items scored using a 5-point ordinal scale where 0 = "normal", 1 = "slight", 2 = "mild", 3 = "moderate", 4 = "severe". Higher scores indicate increased severity
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in the level of disability as measured by the EDSS (Kurtzke, 1983) only in the MS group
EDSS evaluates changes in their level of disability. It provides a total score on a scale that ranges from 0 to 10 in 0.5-unit increments. Higher scores indicate higher levels of disability.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in sensory-motor function of the upper limb as measured by the Fugl-Meyer Assessment - Upper Extremity (Fugl Meyer et al. 1975) only in post-stroke group
The FMA-UL will be used to assess the motor functioning of the upper limb. Scoring is based on direct observation of performance. Items are scored using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. The total possible motor score for the upper extremity is 66.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in motor function of the upper limb as measured by the Action Research Arm Test (ARAT; Lyle, 1981) only in post-stroke group
The ARAT is a 19-item measure assessing the upper extremity performance (coordination, dexterity and functioning). Items are scored using a 4-point ordinal scale where 0 = "no movement", 1= "movement task is partially performed", 2 = "movement task is completed but takes abnormally long", and 3 = "movement is performed normally". Scores range from 0-57 points with higher scores indicating better performance.
Measured: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion29 May 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-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
- Model description
- This study is designed as a single-blinded, randomized, two-treatment arms controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Ico Falck
- Responsible party
- Sponsor
- Investigators
- FRANCESCA BAGLIO, MD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009770
- Sponsor's protocol ID
- TELENEURO@REHAB
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Telerehabilitation Protocols With Digital and Robotic Tools for the Continuity of Care of People With Chronic Neurological Disorders - TELENEURO@REHAB"
- ClinicalTrials.gov ID
- NCT06009770
- Acronym / sponsor ID
- TELENEURO@REHAB
- Conditions
- Post-stroke, Parkinson Disease, Multiple Sclerosis
- Keywords
- Telerehabilitation, Digital medicine, Robotics, Chronic Neurological conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Ico Falck
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 29 May 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Aug 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.
The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). The main questions it aims to answer are 1)the usability and acceptability of the system; 2)the level of safety of intervention; 3) the efficacy of the telerehabilitation protocol. Participants will be randomized (with an allocation ratio of 1:1) into either the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 motor rehabilitation sessions performed at home according to the usual care treatment procedure). Researchers will compare the experimental group and the active control group to see if the TR protocol with digital and robotic tools is effective in reducing the perceived level of disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a single-blinded, randomized, two-treatment arms controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel)The TR intervention for people with PD, MS, and people post-stroke will be focused on addressing impairments and functional limitations that affect activities and participation in everyday life. 1. Frequency: 5 weeks (4 sessions/week) of TR intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous, in-clinic session/week); 2. Intensity: customized according to the patient's functional abilities (system's feedback); 3. Time: 50 minutes/session; 4. Type: according to the disease, TR protocols with a digital system (for MS and PD) or robotic tool (for post-stroke). |
| Usual Care | Active comparator | Behavioral: Usual CareConventional rehabilitation exercises at home, customized according to the disease. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of chronic post-stroke condition with ischemic or haemorrhagic stroke injury occurred 4-6months before recruitment and with motor impairment of the upper limb > 2 to the Medical Research Council scale (MRC); or diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004); or diagnosis of MS, RR-SP forms, according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) < 6;
- age between 25 and 85 years;
- preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test >17.36) (Conti et al., 2015);
- agreement to participate with the signature of the informed consent form;
- no rehabilitation program in place at the time of enrolment;
Key exclusion criteria (6 listed)
- presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
- presence of major psychiatric complications or personality disorders;
- presence of severe impairment of visual and/or acoustic perception;
- relapse ongoing/at least 3 months since the last relapse (MS group);
- presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
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 |
|---|---|---|
| medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel)Rehabilitation activities for PD and MS will be aimed at improving motor performance and balance using a task-oriented approach with Homing system technology; post-stroke patients will perform a home-based upper limb rehabilitation with the iCONE robotic device for robot-assisted neurorehabilitation of the upper limb. | Device | Telerehabilitation |
| Usual CareStandard motor exercise training aimed at muscle mobilization and strengthening (MS and PD groups) or to mobilize and enhance motor control of upper limb functions (post-stroke group) | Behavioural | Usual Care |
Primary outcome
Change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0, Federici et al., 2017)
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).
14 secondary outcomes
Change in global cognitive functioning as measured by the Montreal Cognitive Assessment (MoCA test, Conti et al., 2015) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the Trail Making Test (TMT part A and B, Giovagnoli et al., 1996) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the and the Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in depressive symptoms as measured by the Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in anxiety level as measured by the State-Trait Anxiety Inventory - Form Y (STAI - Y2; Spielberger, 1983; Pedrabissi & Santinello, 1989) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in gross manual dexterity as measured by the Box and Block Test (BBT; Desrosiers et al., 1994) in PD, MS, and post-stroke groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in finger dexterity as measured by the Nine Hole Peg Test (Feys et al., 2017) in PD and MS groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in dynamic balance as measured by the modified Dynamic Gait Index (mDGI; Anastasi et al., 2019) in PD and MS groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in static and dynamic balance as measured by the Mini-Best Test (Franchignoni et al., 2010) in PD and MS groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale (ABC; Cattaneo et al., 2006; Franchignoni et al., 2014) in PD and MS groups
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in motor functionality as measured by the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS; Goetz et al., 2008) part III only in the PD group
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in the level of disability as measured by the EDSS (Kurtzke, 1983) only in the MS group
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in sensory-motor function of the upper limb as measured by the Fugl-Meyer Assessment - Upper Extremity (Fugl Meyer et al. 1975) only in post-stroke group
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Change in motor function of the upper limb as measured by the Action Research Arm Test (ARAT; Lyle, 1981) only in post-stroke group
Time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- internet page of InstitutionLink provided by the sponsor.
- internet page of Research UnitLink provided by the sponsor.
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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.
FRANCESCA BAGLIO, MD principal investigator
Fondazione Don Carlo Gnocchi ETS
Questions about this trial
What is this clinical trial studying?
A study testing medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel) in people with Post-stroke and Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS.
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 6 inclusion and 6 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 FRANCESCA BAGLIO, MD (00390240308952, fbaglio@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0, Federici et al., 2017) (time frame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)). 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 24 Aug 2023.