Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke

NCT ID: NCT06992700

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2027-06-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dynamic perturbation telerehabilitation

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.

Group Type: EXPERIMENTAL

Dynamic perturbation-based intervention

Intervention Type: DEVICE

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.

Conventional telerehabilitation

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);

Group Type: ACTIVE_COMPARATOR

Exercises without dynamic perturbations

Intervention Type: OTHER

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);

Interventions

Dynamic perturbation-based intervention

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.

Intervention Type: DEVICE

Exercises without dynamic perturbations

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);

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciano Fadiga, MD PhD

Role: STUDY_CHAIR

Università degli Studi di Ferrara

Locations

Ferrara University Hospital

Ferrara, Emilia-Romagna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sofia Straudi, MD PhD

Role: CONTACT

strsfo@unife.it

+ 39 0532238830

Facility Contacts

Sofia Straudi, MD PhD

Role: primary

strsfo@unife.it

+ 39 0532238830

Other Identifiers

PER ASPERA

Identifier Type: -

Identifier Source: org_study_id