Stroke
Conditions
Keywords
rehabilitation, telerehabilitation, digital technologies, home-based
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.
Interventions
OTHERIntegrated Treatment with Digital Tools
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.
OTHERHome-Based Educational Program
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.
Sponsors
Istituti Clinici Scientifici Maugeri SpA
IRCCS National Neurological Institute C. Mondino Foundation
Ospedale Policlinico San Martino
C.O.T. Cure Ortopediche Traumatologiche S.p.A.
Università di Pavia
Scuola Superiore Sant'Anna di Pisa
Campus Bio-Medico University
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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). |
| 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 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go | Baseline | The Timed Up and Go (TUG) test is a simple and widely used assessment to evaluate mobility, balance, walking ability, and fall risk.The test measures the time (in seconds) it takes for a person to: (i) Stand up from a standard chair (seat height \ 46 cm); (ii) Walk 3 meters (10 feet) forward at a comfortable pace; (iii) Turn around at the 3-meter mark; (iv) Walk back to the chair; (v) Sit down again. The total time taken is recorded, with specific cut-off values indicating different levels of mobility impairment and fall risk. |
| Computer skills questionnaire | Baseline | It is an ad-hoc questionnaire to assess computer skills. It collects information regarding personal competencies in the use of technology, with items rated on a 5-point scale (1 to 5) to evaluate both the level of knowledge and the frequency of technology use. The questionnaire also includes general information questions about computer skills, assessed using a dichotomous (yes/no) scale. |
| Technology Acceptance Model | Within 7 days after the end of the 6-week observation/rehabilitation period | It is a questionnaire used with the primary aim of identifying the determinants involved in the acceptance of Robotic and Allied Technology. The questionnaire consists of 4 sections (perceived usefulness, ease of use, compatibility, intention to use); each question includes a 7-point Likert scale, from 1 (worst) to 7 (best). The scoring is calculated for each section and is given by the average of the responses in that section, ranging from 1 (worst) to 7 (best). |
| Questionnaire for satisfaction | Baseline; within 7 days after the end of the 6-week observation/rehabilitation period | This is an ad-hoc questionnaire designed to measure satisfaction with healthcare services. Each question uses a 5-point Likert scale, ranging from 1 (unsatisfied) to 5 (very satisfied). |
| System Usability Scale - SUS | Within 7 days after the end of the 6-week observation/rehabilitation period | The SUS is a 10 items questionnaire evaluating the perceived usability of a technological system or device. Each item is scored on a Likert scale from 0 to 5, and the total score range from 0 to 100. Higher scores are indicative of higher perceived usability. |
| Questionnaire for costs | Baseline; within 7 days after the end of the 6-week observation/rehabilitation period | Ad-hoc questionnaire to evaluate the costs (direct healthcare costs, direct non-healthcare costs, indirect costs) incurred by the patient, in euros. |
| Questionnaire for perception of problems and solution complexity | Baseline; within 7 days after the end of the 6-week observation/rehabilitation period | It is an ad-hoc questionnaire for perception of problems and solution complexity. Each question utilizes a 5-point Likert scale, ranging from 1 (low complexity) to 5 (very complex). |
| Incremental cost-utility ratio | During the study, an average of 14 months | The incremental cost-utility ratio (ICUR) will serve as the key metric of the Cost-utility analysis, and it is calculated as the ratio between differences in costs and differences in utility across the analysis groups. Cost-utility analysis will assess and compare the efficiency of alternative rehabilitation interventions by measuring health outcomes in terms of utility, a measure of general well-being or quality of life (subjective measures), relative to the costs incurred to achieve these outcomes. Utilities will be evaluated using standardized measures based on quality of life. Each health condition identified through generic health-related quality of life questionnaires (EQ-5D-DL) will be associated with available utility scores specific to Italy. |
| Incremental cost-effectiveness ratio | During the study, an average of 14 months | The incremental cost-effectiveness ratio (ICER) is calculated by dividing the difference in costs between the alternative rehabilitation models tested in the clinical study by the difference in clinical outcomes (physical units - objective measures). It will be used as the key metric of the cost-effectiveness analysis, that will compare the costs and clinical outcomes of the alternative rehabilitation models being studied. The ICER represents the additional cost incurred to achieve an incremental unit of effectiveness, that will be assessed considering primary and secondary outcomes. |
| Financial impact (differences in direct health costs) | During the study, an average of 14 months | From the perspective of the payer, the expected outcome of the budget impact analysis is the assessment of the financial impact (differences in direct health costs) over a 3-5 year period for the diffusion of a mix of robotic-based rehabilitations, compared to conventional rehabilitation or a robotic solution. The financial impact will be assessed by considering the direct health costs associated with the different rehabilitation regimes, varying projections of robotic market uptake, and the degrees of substitutability between the compared rehabilitation regimes. |
| Working-Related Quality of Life | During the study, an average of 14 months | The Work-Related Quality of Life (WRQoL) scale is a 23-item psychometric instrument designed to measure employees' perceived quality of working life across six psychosocial sub-factors. In this context, the WRQoL scale will be administered to healthcare professionals to assess and better understand their work-related quality of life. Each response will be rated on a 5-point scale (1 to 5). |
| premorbid Modified Rankin Scale | Baseline | The pre-stroke Modified Rankin Score (mRS) is an estimated score used to assess the patient's pre-stroke level of function. It has a grade ranging from 0 (no symptoms) to 6 (dead). |
| Montreal Cognitive Assessment Scale | Baseline | The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It ranges from 0 (worst) to 30 (best). |
Countries
Italy
Contacts
Primary ContactIrene G Aprile, MD, PhD
Backup ContactMarco Germanotta, PhD
Outcome results
None listed