Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2026-07-31

Brief Summary

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Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.

This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.

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Detailed Description

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The aim of this study is to evaluate, in a pragmatic trial on a large sample of patients who have experienced a stroke within the six months prior to enrollment, the effectiveness of a multimodal treatment using robotics and advanced technologies compared to traditional multimodal treatment, in the recovery of activities of daily living.

Primary Objective: To demonstrate, in a population of subacute stroke patients, the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitative treatment in the recovery of activities of daily living.

Secondary Objectives:

* To demonstrate the superiority of rehabilitative treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the recovery of activities of daily living, should non-inferiority be demonstrated;
* To compare the improvements between two groups in all targeted domains (upper limb sensorimotor abilities; lower limb sensorimotor abilities and gait; balance; cognitive abilities), in accordance with the International Classification of Functioning, Disability, and Health (ICF);
* To analyze the neurophysiological parameters and factors involved in neuroplasticity processes;
* To compare the time pattern of manual dexterity and walking performance recovery in the two groups;
* To assess the effects of the rehabilitation treatment in terms of daily life activities and quality of life through medium-term follow-up;
* To evaluate the acceptability and usability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, their family, and the healthcare practitioner;
* To create a predictive model capable of forecasting the effectiveness of robotic and technological treatment in subjects after a stroke, based on a detailed description of the patient at baseline (using demographic data and clinical picture at admission);
* To assess the economic sustainability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, payer, and society, through the creation of a model for the assessment and prediction of cost-effectiveness, cost-utility, and, for the healthcare system, a Budget Impact Analysis, and related sensitivity analyses.

The study employs a multicenter, multimodal, randomized, controlled, parallel-group (1:1) interventional design with blinded assessors, following a pragmatic approach. It will be conducted across multiple clinical centers involved in a national research initiative, encompassing both outpatient and inpatient settings. Randomization will be centralized and stratified by clinical center, latency, and clinical setting (inpatients or outpatients).

The sample size (596 patients) was determined considering the following, with respect to the primary outcome (the change in the modified Barthel Index): (a) the non-inferiority of robotic treatment compared to traditional treatment; (b) a power of 80%; (c) a non-inferiority margin of 5 points; (d) a bilateral 95% confidence interval; (e) a standard deviation of the primary outcome of 20 points. Considering these parameters, a sample size of 506 patients (253 per group) is obtained. Additionally, considering a dropout rate of 15%, a total sample size of 596 patients is obtained. The same sample size is sufficient to also demonstrate the potential superiority of robotic treatment. In fact, considering a significance level of 5%, a power of 80%, a minimal clinically important difference of the scale of 9.25 points, a standard deviation of 20 points, and a dropout rate of 15%, a total of 178 patients are required for demonstrating superiority.

The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio. In both groups, patients will undergo comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities.

The primary outcome is to demonstrate non-inferiority in activities of daily living as measured by the modified Barthel Index. Should non-inferiority be established, the study will then evaluate the potential superiority of RADTs in activities of daily living.

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Integrated Treatment with Robotic & Technological Devices (RADTs)

This intervention employs various RADTs to target the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities. For upper limb sensorimotor function, we will use planar end-effector robots, exoskeletons, or electromechanical systems for shoulder, elbow, and wrist rehabilitation; end-effector robots or exoskeletons for hand rehabilitation; and sensor-based devices for comprehensive upper limb treatment. For lower limb sensorimotor function, we will utilize end-effector robots or exoskeletons and treadmills with body-weight support systems. Balance training will involve stabilometric platforms and sensor-based systems. Cognitive functions will be addressed using digital systems, sensor-based devices, and virtual reality programs. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.

Group Type EXPERIMENTAL

robotic rehabilitation

Intervention Type OTHER

Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity.

Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency:

* 5 times a week for 5 weeks, for inpatients;
* 3 times a week for 8.3 weeks, for outpatients.

Traditional Treatment

In the control group, subjects will undergo a standard traditional rehabilitation program without the use of RADTs, focusing on the following domains:a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities, using traditional methods of physiotherapy and cognitive rehabilitation.

Group Type ACTIVE_COMPARATOR

traditional rehabilitation

* Clinical instability;
* Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \<10);
* Rigidity or hypertonia (Modified Ashworth Scale \> 3) in the plegic/paretic limb;
* Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
* Pregnant women;
* Refusal to sign the informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No