Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients
- Conditions
- Stroke
- Registration Number
- NCT06978413
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.
- Age greater than 18 years.
- Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.
- Ability to perform the Timed Up and Go Test.
- Unstable clinical conditions.
- Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment<17.5).
- Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.
- Refusal to sign informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in the Berg Balance Scale (BBS) Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
- Secondary Outcome Measures
Name Time Method Fugl-Meyer Assessment for the upper extremities - motor function Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Fugl-Meyer Assessment for the upper extremities - sensory function Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Fugl-Meyer Assessment for the lower extremities - sensory function Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Modified Ashworth Scale Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
5-level EQ-5D version (EQ-5D-5L) Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
Fugl-Meyer Assessment for the lower extremities - motor function Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Modified Rivermead Motricity Index Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
Symbol Digit Modalities Test Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
Motricity Index for upper extremities Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Functional Ambulation Classification Scale Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
Frontal Assessment Battery Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
World Health Organization disability assessment schedule 2.0 - WHODAS 2.0 Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Modified Barthel Index Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Motricity Index for lower extremities Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Trunk control test Baseline; within 7 days after the end of the 6-week observation/rehabilitation period The Trunk control test (TCT) measures four simple aspects of trunk movement. Total score range from 0 (minimum) to 100 (maximum, indicating better performance).
Numerical Rating Scale for Pain Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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).
Neuropathic Pain 4 Questions Baseline; within 7 days after the end of the 6-week observation/rehabilitation period 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.
Trial Locations
- Locations (10)
Fondazione Don Carlo Gnocchi, Centro Gala
🇮🇹Acerenza, Italy
IRCCS Istituti Clinici Scientifici Maugeri
🇮🇹Telese Terme, Italy
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
🇮🇹Milan, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
IRCCS Fondazione Mondino
🇮🇹Pavia, Italy
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
🇮🇹Salerno, Italy
COT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico
🇮🇹Messina, Italy
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
🇮🇹Rome, Italy
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
🇮🇹Sant'Angelo Dei Lombardi, Italy
Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
🇮🇹Tricarico, Italy