StrokePER ASPERANCT06992700
Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke
A study testing Dynamic perturbation-based intervention and Exercises without dynamic perturbations in people with Stroke, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitation Medicine Unit (UMR) of the Ferrara University Hospital (Department of Neuroscience), patients will undergo a 10-day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dynamic perturbation-based intervention and Exercises without dynamic perturbations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 years or older;
- Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (i.e. at least 6 months after the onset of the acute event) verified by brain imaging (brain computed tomography and/or magnetic resonance imaging);
- Motor deficit in the upper limb - and in particular in the hand - caused by stroke, not attributable to other conditions or diseases and not such as to preclude the ability to perform movements with the fingers and to perform movements to grasp objects;
- Ability to express informed consent correctly.
- Availability of a webcam and Internet connection at home for remote supervision of activities by the staff involved in the study.
Who cannot join
- Medical conditions that may interfere with the ability to safely complete the study protocol;
- Cognitive dysfunction that precludes informed consent;
- Severe neuropsychological disorders;
- Severe visual problems;
- Upper limb pain assessed with Visual Analogue Scale (VAS) > 7;
- Severe internal diseases (e.g. cardiopulmonary, renal, hepatic);
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- Diseases with inflammatory skin lesions, wounds, sensory and circulatory disorders below the elbow and on the hand in the area of application;
- Contraindications to transcranial magnetic stimulation (TMS) procedures, assessed as indicated by international reference, such as: presence of intracranial metal implants, positive history of epilepsy, frequent migraines, implantable devices (ventricular-peritoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants). It should be noted that the presence of this type of exclusion criterion will preclude the performance of TMS assessments, but not the remaining procedures of the study;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ferrara University Hospital
Ferrara, Emilia-Romagna, 44124
Sofia Straudi, MD PhD, + 39 0532238830, strsfo@unife.it
Annibale Antonioni, MD
About this study
Official title: Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitation Medicine Unit (UMR) of the Ferrara University Hospital (Department of Neuroscience), patients will undergo a 10-day home rehabilitation programme (two consecutive weeks, five days a week, two daily sessions of one hour each) with remote supervision by study staff in a randomised manner in two groups:
- Experimental group: patients in this group will perform the exercises at at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers.
- Control group: patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (in order to stabilise the wrist and eliminate this potential confounding variable) but without the springs that provide resistance (i.e. eliminating the elastic resistance that is the subject of this study); Assignment to the treatment group will be based on a randomisation list (generated through https://www.random.org/ to obtain a balanced division) established by the Scientific Director of the study and communicated exclusively to the personnel involved in administering the treatment sessions, while it will not be disclosed to the personnel involved in the other phases of the study. This will allow for the division of patients and an evaluation of the effectiveness of the treatment between the two groups to be as objective as possible. At the end of the ten days of treatment, patients will return to the facilities of the UMR of the Ferrara University Hospital and repeat the assessments already carried out at baseline, in order to evaluate pre/post performance differences after the home treatment and the differences between the two groups. Finally, questionnaires will be administered to assess fatigue at the end of each day of treatment and patient satisfaction in relation to this telerehabilitation approach at the end of the ten days. It should be noted that patients allocated to the control group will be offered the opportunity to undergo the same treatment as the experimental group, i.e. using the orthosis, in order to ensure that all participants have an equal opportunity to benefit from the innovative protocol.
Read more
Type of subjects to be enrolled: Subjects diagnosed with chronic cerebral stroke (i.e. at least 6 months after the onset of the acute event) among patients attending the UMR of the Ferrara University Hospital on an outpatient/day-hospital basis for current or previous multidisciplinary rehabilitation treatment specific to the needs of the individual patient.
Information/Consent: Each participant will be assessed to determine their preliminary eligibility, informed about the aim and procedures of the study, provided with all necessary information for possible participation in the study and sign the informed consent form.
Suspension procedure: At any time during the trial, participants may suspend or withdraw from the study at their own discretion. Breaks during the sessions are also provided for if the participant experiences fatigue, which is the only expected adverse effect, in line with what generally found in any form of repeated physical exercise. Such suspensions will be granted whenever requested, in order to alleviate the participant's discomfort and promote their full participation in the treatment sessions.
- Conditions
- Stroke
- Being tested
- Dynamic perturbation-based intervention, Exercises without dynamic perturbations
- Keywords
- Stroke, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic perturbation-based interventionDevice
The patient will be asked to perform simple motor tasks while wearing the glove at home under remote supervision of the staff involved in the study. In this way, in order to complete the task, the patient will be forced to overcome the elastic force and perform the movement with greater control. What is innovative compared to the common application of this device is its purpose: specifically, the orthosis will be used by applying resistance to the distal phalanx of the fingers of the hand characterised by a stenic deficit. Contrary to the usual application, which involves the use of this device to facilitate deficient movements, it is hypothesised that the application of resistance will induce the central nervous system (CNS) to create alternative strategies offering them the variety and difficulty necessary to stimulate adaptation without subjecting them to stress resulting from sudden and excessive levels of challenge.
Exercises without dynamic perturbationsOther
Patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (to stabilise the wrist and eliminate this possible confounding variable), but without the springs that determine resistance (i.e., eliminating the elastic resistance that is the subject of this study);
| Study group | Role | What they receive |
|---|---|---|
| Dynamic perturbation telerehabilitation | Experimental | Patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers. Patients will be able to request breaks from using the glove and/or interrupt the session at any time. In order to assess adherence, the time of use of the glove by each patient will be quantified over the period of time available. Receives: Device: Dynamic perturbation-based intervention |
| Conventional telerehabilitation | Active comparator | Patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (to stabilise the wrist and eliminate this possible confounding variable), but without the springs that determine resistance (i.e., eliminating the elastic resistance that is the subject of this study); Receives: Other: Exercises without dynamic perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
An assessment scale designed to quantify upper limb function in patients with brain damage resulting in hemiparesis. It identifies the subject's ability to handle objects of different shapes, sizes, and materials, and is considered an indirect measure of activity limitation. It consists of 19 items in total, and the score ranges from 0 to 57. Higher scores indicate better motor performance.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Jebsen-Taylor Hand Function Test (JTHFT)
Standardised and objective assessment test for hand motor function; allows both precision and gross tasks to be assessed during the simulation of everyday tasks. It consists of seven activities (writing, turning a page, lifting small objects and placing them in a container, stacking blocks, simulated feeding, moving an empty container, moving a full container). The total score is calculated based on the time taken for each individual test (shorter times indicate better performance).
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Nine Hole Peg Test (9HPT)
It assesses finger dexterity in patients with various types of neurological disorders, including stroke, Parkinson's disease, multiple sclerosis, etc. The equipment consists of: a wooden or plastic board with 9 holes (diameter 10 or 15 mm) spaced 32 or 50 mm apart; 9 pegs (diameter 7 mm, length 32 mm); a container for the pegs; a stopwatch. The patient is asked to place each peg in the holes in the board and then remove them and reposition them in the container as quickly as possible. During the test, the time taken to complete the task is calculated, from the moment the first peg is picked up to when the last one is placed back in the container. Alternatively, the number of pegs placed in 50 or 100 seconds is counted. Longer completion times (or fewer pegs moved, depending on the assessment method) indicate poorer performance.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Box and Block Test (BBT)
Hand movement dexterity assessment test measures the ability to grasp large objects that do not require fine motor control. It is used with a wide range of patients with neurological disorders, including motor deficits caused by stroke. It consists of a wooden box divided into two halves and 150 wooden cubes placed in the same half. The patient is asked to move as many cubes as possible, one at a time, within 60 seconds. The score is calculated based on the number of cubes the patient manages to transfer. The test is repeated after a period of time to assess the patient's progress. A higher number of cubes indicates better performance.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Secondary outcomes (6)
Resting Motor Threshold
Unit of Measure: % of maximum stimulator output Resting Motor Threshold (RMT) will be defined as the minimum stimulation intensity (expressed as a percentage of the maximum stimulator output) required to elicit motor evoked potentials (MEPs) of at least 50 μV in 5 out of 10 consecutive trials from the first dorsal interosseous (FDI) muscle of the paretic limb. Measurements will be performed using a Bistim stimulator (Magstim, UK) with participants at rest. The same stimulation parameters will be applied consistently across sessions.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Modified Ashworth Scale (MAS)
A scale for assessing muscle tone alteration following central nervous system injury in the upper limbs; it is a test of resistance to passive movements of a body segment, and the score ranges from 0 to 4 (the higher the score, the greater the spasticity).
Measured: Baseline
Stroke Impact Scale (SIS)
It assesses the types and intensity of support that a person with disabilities may need to best manage relevant activities of daily living. It consists of three sections comprising: i) 49 activities of living, with 49 items, grouped into 6 subscales (activities in the home or community, learning activities throughout life, activities related to employment, health, safety and social activities); ii) an additional scale of legal protection, with 8 items; iii) non-ordinary medical and behavioural support needs divided into two parts with 29 items (medical support needs, behavioural support needs). Sections 1 and 2 require the use of a 5-point Likert scale (0 to 4) that assesses frequency (0 - less than once a month; 4 - every hour or more), daily duration of support (0 - never; 4 - 4 hours or more), and type of support (0 - none; 4 - total physical assistance). A higher number indicates a significant impact of stroke on quality of life.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Numerical Rating Scale for Fatigue (NRS)
A simple tool for assessing the parameter of 'fatigue'. The patient is asked to quantify the fatigue experienced by indicating the corresponding number on a scale ranging from 0 (no perceived fatigue) to 10 (maximum fatigue imaginable). Higher scores indicate a higher level of perceived fatigue.
Measured: At the end of each of the two daily treatment sessions.
Satisfaction questionnaire on the proposed home-based intervention:
Each participant will be asked to complete a satisfaction questionnaire in order to assess the feasibility, tolerability, and satisfaction in relation to the proposed rehabilitation method.
Measured: End of intervention (after 10 days of two sessions per day)
Motor Evoked Potential (MEP) Amplitude
Unit of Measure: microvolts (μV) Corticospinal excitability will also be assessed by recording Motor Evoked Potential (MEP) amplitudes from the FDI muscle following 10 single-pulse TMS stimuli delivered over the primary motor cortex (M1) of the affected hemisphere at an intensity of resting motor threshold (RMT) + 20%. Muscle relaxation will be visually confirmed through electromyography (EMG) monitoring before each stimulus.
Measured: Baseline; End of intervention (after 10 days of two sessions per day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
- Investigators
- Luciano Fadiga, MD PhD, Study chair, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992700
- Sponsor's protocol ID
- PER ASPERA
- Acronym
- PER ASPERA
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 28 May 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06992700
- Acronym / sponsor ID
- PER ASPERA / PER ASPERA
- Conditions
- Stroke
- Keywords
- Stroke, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 May 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.
Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitation Medicine Unit (UMR) of the Ferrara University Hospital (Department of Neuroscience), patients will undergo a 10-day home rehabilitation programme (two consecutive weeks, five days a week, two daily sessions of one hour each) with remote supervision by study staff in a randomised manner in two groups:
- Experimental group: patients in this group will perform the exercises at at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers.
- Control group: patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (in order to stabilise the wrist and eliminate this potential confounding variable) but without the springs that provide resistance (i.e. eliminating the elastic resistance that is the subject of this study); Assignment to the treatment group will be based on a randomisation list (generated through https://www.random.org/ to obtain a balanced division) established by the Scientific Director of the study and communicated exclusively to the personnel involved in administering the treatment sessions, while it will not be disclosed to the personnel involved in the other phases of the study. This will allow for the division of patients and an evaluation of the effectiveness of the treatment between the two groups to be as objective as possible. At the end of the ten days of treatment, patients will return to the facilities of the UMR of the Ferrara University Hospital and repeat the assessments already carried out at baseline, in order to evaluate pre/post performance differences after the home treatment and the differences between the two groups. Finally, questionnaires will be administered to assess fatigue at the end of each day of treatment and patient satisfaction in relation to this telerehabilitation approach at the end of the ten days. It should be noted that patients allocated to the control group will be offered the opportunity to undergo the same treatment as the experimental group, i.e. using the orthosis, in order to ensure that all participants have an equal opportunity to benefit from the innovative protocol.
Type of subjects to be enrolled: Subjects diagnosed with chronic cerebral stroke (i.e. at least 6 months after the onset of the acute event) among patients attending the UMR of the Ferrara University Hospital on an outpatient/day-hospital basis for current or previous multidisciplinary rehabilitation treatment specific to the needs of the individual patient.
Information/Consent: Each participant will be assessed to determine their preliminary eligibility, informed about the aim and procedures of the study, provided with all necessary information for possible participation in the study and sign the informed consent form.
Suspension procedure: At any time during the trial, participants may suspend or withdraw from the study at their own discretion. Breaks during the sessions are also provided for if the participant experiences fatigue, which is the only expected adverse effect, in line with what generally found in any form of repeated physical exercise. Such suspensions will be granted whenever requested, in order to alleviate the participant's discomfort and promote their full participation in the treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic perturbation telerehabilitation | Experimental | Device: Dynamic perturbation-based interventionPatients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers. Patients will be able to request breaks from using the glove and/or interrupt the session at any time. In order to assess adherence, the time of use of the glove by each patient will be quantified over the period of time available. |
| Conventional telerehabilitation | Active comparator | Other: Exercises without dynamic perturbationsPatients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (to stabilise the wrist and eliminate this possible confounding variable), but without the springs that determine resistance (i.e., eliminating the elastic resistance that is the subject of this study); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged 18 years or older;
- Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (i.e. at least 6 months after the onset of the acute event) verified by brain imaging (brain computed tomography and/or magnetic resonance imaging);
- Motor deficit in the upper limb - and in particular in the hand - caused by stroke, not attributable to other conditions or diseases and not such as to preclude the ability to perform movements with the fingers and to perform movements to grasp objects;
- Ability to express informed consent correctly.
- Availability of a webcam and Internet connection at home for remote supervision of activities by the staff involved in the study.
Key exclusion criteria (9 listed)
- Medical conditions that may interfere with the ability to safely complete the study protocol;
- Cognitive dysfunction that precludes informed consent;
- Severe neuropsychological disorders;
- Severe visual problems;
- Upper limb pain assessed with Visual Analogue Scale (VAS) > 7;
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 |
|---|---|---|
| Dynamic perturbation-based interventionThe patient will be asked to perform simple motor tasks while wearing the glove at home under remote supervision of the staff involved in the study. In this way, in order to complete the task, the patient will be forced to overcome the elastic force and perform the movement with greater control. What is innovative compared to the common application of this device is its purpose: specifically, the orthosis will be used by applying resistance to the distal phalanx of the fingers of the hand characterised by a stenic deficit. Contrary to the usual application, which involves the use of this device to facilitate deficient movements, it is hypothesised that the application of resistance will induce the central nervous system (CNS) to create alternative strategies offering them the variety and difficulty necessary to stimulate adaptation without subjecting them to stress resulting from sudden and excessive levels of challenge. | Device | Dynamic perturbation telerehabilitation |
| Exercises without dynamic perturbationsPatients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (to stabilise the wrist and eliminate this possible confounding variable), but without the springs that determine resistance (i.e., eliminating the elastic resistance that is the subject of this study); | Other | Conventional telerehabilitation |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
An assessment scale designed to quantify upper limb function in patients with brain damage resulting in hemiparesis. It identifies the subject's ability to handle objects of different shapes, sizes, and materials, and is considered an indirect measure of activity limitation. It consists of 19 items in total, and the score ranges from 0 to 57. Higher scores indicate better motor performance.
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
Standardised and objective assessment test for hand motor function; allows both precision and gross tasks to be assessed during the simulation of everyday tasks. It consists of seven activities (writing, turning a page, lifting small objects and placing them in a container, stacking blocks, simulated feeding, moving an empty container, moving a full container). The total score is calculated based on the time taken for each individual test (shorter times indicate better performance).
Nine Hole Peg Test (9HPT)
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
It assesses finger dexterity in patients with various types of neurological disorders, including stroke, Parkinson's disease, multiple sclerosis, etc. The equipment consists of: a wooden or plastic board with 9 holes (diameter 10 or 15 mm) spaced 32 or 50 mm apart; 9 pegs (diameter 7 mm, length 32 mm); a container for the pegs; a stopwatch. The patient is asked to place each peg in the holes in the board and then remove them and reposition them in the container as quickly as possible. During the test, the time taken to complete the task is calculated, from the moment the first peg is picked up to when the last one is placed back in the container. Alternatively, the number of pegs placed in 50 or 100 seconds is counted. Longer completion times (or fewer pegs moved, depending on the assessment method) indicate poorer performance.
Box and Block Test (BBT)
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
Hand movement dexterity assessment test measures the ability to grasp large objects that do not require fine motor control. It is used with a wide range of patients with neurological disorders, including motor deficits caused by stroke. It consists of a wooden box divided into two halves and 150 wooden cubes placed in the same half. The patient is asked to move as many cubes as possible, one at a time, within 60 seconds. The score is calculated based on the number of cubes the patient manages to transfer. The test is repeated after a period of time to assess the patient's progress. A higher number of cubes indicates better performance.
6 secondary outcomes
Resting Motor Threshold
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
Modified Ashworth Scale (MAS)
Time frame: Baseline
Stroke Impact Scale (SIS)
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
Numerical Rating Scale for Fatigue (NRS)
Time frame: At the end of each of the two daily treatment sessions.
Satisfaction questionnaire on the proposed home-based intervention:
Time frame: End of intervention (after 10 days of two sessions per day)
Motor Evoked Potential (MEP) Amplitude
Time frame: Baseline; End of intervention (after 10 days of two sessions per day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
Luciano Fadiga, MD PhD study chair
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic perturbation-based intervention and Exercises without dynamic perturbations in people with Stroke, run by University Hospital of Ferrara 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Straudi, MD PhD (+ 39 0532238830, strsfo@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Baseline; End of intervention (after 10 days of two sessions per day)). The study lists 4 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 May 2025.