Clinical trial NCT06992700: Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke
Official title: Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Neurorehabilitation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
First posted: 2025-05-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
measure: Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
measure: Nine Hole Peg Test (9HPT)
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
measure: Box and Block Test (BBT)
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
Secondary outcomes:
measure: Resting Motor Threshold
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
measure: Numerical Rating Scale for Fatigue (NRS)
timeFrame: At the end of each of the two daily treatment sessions.
measure: Satisfaction questionnaire on the proposed home-based intervention:
timeFrame: End of intervention (after 10 days of two sessions per day)
measure: Motor Evoked Potential (MEP) Amplitude
timeFrame: Baseline; End of intervention (after 10 days of two sessions per day)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
state: Emilia-Romagna
Study officials:
affiliation: Università degli Studi di Ferrara
name: Luciano Fadiga, MD PhD
role: STUDY_CHAIR
References: