NCT06992700 Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke
| NCT ID | NCT06992700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of Ferrara |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-03-15 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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); * 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.
Contact & Investigator
Luciano Fadiga, MD PhD
STUDY CHAIR
Università degli Studi di Ferrara
Frequently Asked Questions
Who can join the NCT06992700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992700 currently recruiting?
Yes, NCT06992700 is actively recruiting participants. Contact the research team at strsfo@unife.it for enrollment information.
Where is the NCT06992700 trial being conducted?
This trial is being conducted at Ferrara, Italy.
Who is sponsoring the NCT06992700 clinical trial?
NCT06992700 is sponsored by University Hospital of Ferrara. The principal investigator is Luciano Fadiga, MD PhD at Università degli Studi di Ferrara. The trial plans to enroll 52 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.