The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program. The main question it aims to answer is: Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.
The aim of the study is to evaluate the effectiveness of a home-based treatment based on rehabilitation technologies by comparing it with a traditional educational program at home. Primary objective: Demonstration of the superiority of a home-based rehabilitation program with digital tools (home-based technological telerehabilitation) over a home-based educational program (home-based usual care) in patients with stroke outcomes in improving static and dynamic balance. Secondary objectives: * Evaluation of the impact of the frequency of the intervention on recovery; * Evaluation of the acceptability of the intervention with digital tools for the patient, the caregiver, and the health care provider; * Evaluation of the usability of the intervention with digital tools for the patient and the caregiver; * Evaluation of the economic sustainability of the integrated rehabilitation intervention with digital tools for the patient, the payer, and society through the creation of a cost-effectiveness, cost-utility, and, for the health system, budget impact analysis model evaluation and prediction, and related sensitivity analyses. The study is designed as a multicenter, multimodal, randomized, controlled, parallel group (1:1), blinded interventional trial. It will be conducted at multiple clinical centers participating in a national research initiative. Randomization will be centralized and stratified by clinical center, time since stroke, and age. The sample size was determined using a 2-tailed, 2-sample t-test, assuming a power of 80%, a type I error t of 0.05, a mean difference of 2.7 units on the primary outcome (specifically, the change in the Berg Balance Scale, corresponding to the minimum detectable change in chronic stroke patients) and a common standard deviation of 5.37 points. With these assumptions, a sample size of 128 cases was estimated. Further, considering a dropout rate of 20%, the final estimated sample size required is 160 cases. The calculation was performed using G\*Power software. All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites. Data will be systematically collected using the REDCap (Research Electronic Data Capture) platform.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Patients will undergo a 6-week remote telerehabilitation program. The recommended frequency of treatment is a minimum of 3 sessions per week, but patients may adjust the schedule in agreement with their assigned therapist. If a patient is unable to complete at least 18 sessions due to clinical reasons, they will be considered as a dropout. Moreover, one session per week will be conducted synchronously, with the therapist remotely supervising the patient's activities in real time, while the remaining sessions will be asynchronous, allowing the patient to complete the exercises independently.
Patients will be monitored over a six-week period through weekly phone calls to assess their progress and overall condition. Additionally, participants are required to maintain an activity diary to document their engagement with the prescribed activities.
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza, Italy
NOT_YET_RECRUITINGIRCCS Istituti Clinici Scientifici Maugeri
Bari, Italy
NOT_YET_RECRUITINGIRCCS Ospedale Policlinico San Martino
Genova, Italy
NOT_YET_RECRUITINGCOT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico
Messina, Italy
NOT_YET_RECRUITINGFondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan, Italy
NOT_YET_RECRUITINGIRCCS Istituti Clinici Scientifici Maugeri
Milan, Italy
NOT_YET_RECRUITINGIRCCS Istituti Clinici Scientifici Maugeri
Montescano, Italy
NOT_YET_RECRUITINGIRCCS Fondazione Mondino
Pavia, Italy
NOT_YET_RECRUITINGFondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Rome, Italy
RECRUITINGFondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno, Italy
NOT_YET_RECRUITING...and 3 more locations
Change from baseline in the Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the upper extremities - motor function
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity motor function domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. It ranges from 0 (hemiplegia) to 66 (normal motor performance).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the upper extremities - sensory function
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity sensory function domain evaluates light touch on two surfaces of the arm, and position sense for upper limb joints. It ranges from 0 to 12 (normal sensory function).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the lower extremities - motor function
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity motor function domain includes items assessing movement, coordination, and reflex action of the hip, knee, and ankle. It ranges from 0 (hemiplegia) to 34 (normal motor performance).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the lower extremities - sensory function
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity sensory function domain evaluates light touch on two surfaces of the leg, and position sense for lower limb joints. It ranges from 0 to 12 (normal sensory function).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Rivermead Motricity Index
The Modified Rivermead Motricity Index (MRMI) is a clinical tool used to assess motor function and mobility in patients with neurological impairments. It consists of 8 items that evaluate motor control, balance, and mobility, with a total possible score of 40 points. Each item is scored on a 5-point ordinal scale (0-5), with higher scores indicating better function.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Symbol Digit Modalities Test
The Symbol Digit Modalities Test evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned. The higher the score, the faster the information processing speed.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Barthel Index
The modified Barthel Index for Activities of Daily Living is a validated ordinal scale which measures a person's ability to complete activities of daily living (ADL). Scores range from 0 (total dependence) to 100 (total independence).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0 to 4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The lower the score, the lower the spasticity. Upper and lower joints spasticity is assessed.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Motricity Index for upper extremities
The Motricity Index (MI) is an ordinal method of measuring limb strength. For upper extremity test, shoulder abduction, elbow flexion, pinch grip are considered. It ranges from 0 (worse) to 100 (normal strength).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Motricity Index for lower extremities
The Motricity Index (MI) is an ordinal method of measuring limb strength. For lower extremity test, hip flexion, knee extension, and ankle dorsiflexion are considered. It ranges from 0 (worse) to 100 (normal strength).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Trunk control test
The Trunk control test (TCT) measures four simple aspects of trunk movement. Total score range from 0 (minimum) to 100 (maximum, indicating better performance).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Numerical Rating Scale for Pain
The Numerical Rating Scale fo Pain (NRSP) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Neuropathic Pain 4 Questions
The Neuropathic Pain 4 Questions (DN4) is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Functional Ambulation Classification Scale
The Functional Ambulation Classification (FAC) Scale is a simple and widely used tool to assess a person's ability to walk (ambulate) independently after a neurological injury. It evaluates how much physical support a person needs while walking and helps clinicians classify their functional mobility. The FAC consists of six levels (0-5), ranging from non-functional ambulation to independent walking.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Frontal Assessment Battery
The Frontal Assessment Battery (FAB) is a clinical tool designed to assess frontal lobe functions, particularly executive functions, which are cognitive processes like problem-solving, decision-making, and impulse control. The FAB consists of six subtests, each scored from 0 to 3, with a maximum total score of 18 points. Higher scores indicate better frontal lobe function.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
World Health Organization disability assessment schedule 2.0 - WHODAS 2.0
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).
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
5-level EQ-5D version (EQ-5D-5L)
The 5-level EQ-5D version (EQ-5D-5L) is a validated tool to assess health-related quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.