Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
NCT ID: NCT06489145
Last Updated: 2024-12-09
Study Results
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-06-24
2025-09-30
Brief Summary
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Detailed Description
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Study 1 (ID: 0025654/24). As a first goal the study aims to investigate pre- post-intervention changes on patients' motor, functional, cognitive, psychological and quality of life outcomes. Intervention effects will be estimated among patients participating in technology-enhanced rehabilitation programs and compared to those undergoing traditional treatment only.
As a second goal, the study aims to evaluate patients' subjective rehabilitation experience, treatment expectations and compliance, and (in case of technology use) devices usability, acceptability and psychosocial impact.
As a third goal, the study aims to extend the evaluation on rehabilitation experience to patients' caregivers, specifically investigating their treatment expectations and, at the end of the intervention, treatment satisfaction.
As a fourth goal, the study aims to evaluate the rehabilitation experience and technology experience of use in patients' therapists, specifically investigating their treatment expectations and, at the end of the intervention, patients' compliance and participation levels in the treatment.
Study 2 (ID: RM-2024-803). Therapists will be also involved in a parallel qualitative investigation through focus-groups to further explore the barriers and facilitators related to the implementation of technological devices into post-stroke rehabilitation programs.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Technology-enhanced Rehabilitation
Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment.
Technology-enhanced Rehabilitation
Based on their individualized rehabilitation project, patients will undergo robot-assisted therapy (RAT) and/or virtual reality (VR)-based treatment.
RAT will consist of the use exoskeleton devices intended for the treatment of upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™) impairments.
VR-based rehabilitation will be conducted non-immersive VR devices: the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), and the Walker View™ (TechnoBody SRL, Italy).
Technology-enhanced treatment duration (number of sessions, minutes of use) will strictly depend on patients' rehabilitation needs and individualized rehabilitation program. Overall, part of the duration of the whole treatment will be dedicated to the use of the technological device, resulting in the same amount of rehabilitation for all participants.
Multidisciplinary Traditional Rehabiltiation
Patients will receive traditional treatment consisting of two daily one-hour session (4 weeks, 20 sessions) and including rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.
Standard Rehabilitation
Patients will participate in multidisciplinary traditional treatment only
Multidisciplinary Traditional Rehabiltiation
Patients will receive traditional treatment consisting of two daily one-hour session (4 weeks, 20 sessions) and including rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.
Interventions
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Technology-enhanced Rehabilitation
Based on their individualized rehabilitation project, patients will undergo robot-assisted therapy (RAT) and/or virtual reality (VR)-based treatment.
RAT will consist of the use exoskeleton devices intended for the treatment of upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™) impairments.
VR-based rehabilitation will be conducted non-immersive VR devices: the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), and the Walker View™ (TechnoBody SRL, Italy).
Technology-enhanced treatment duration (number of sessions, minutes of use) will strictly depend on patients' rehabilitation needs and individualized rehabilitation program. Overall, part of the duration of the whole treatment will be dedicated to the use of the technological device, resulting in the same amount of rehabilitation for all participants.
Multidisciplinary Traditional Rehabiltiation
Patients will receive traditional treatment consisting of two daily one-hour session (4 weeks, 20 sessions) and including rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years;
* Acceptable hyposthenia evaluated with the Motricity Index (scores less than the maximum)
* Spasticity, if present, compatible with limb function (MAS score \< 2)
* Mental health condition allowing for a full understanding of the study objectives and completion of self-report measures
* Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;
* Physiotherapists who assist enrolled patients throughout the entire intervention period
* Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;
Exclusion Criteria
* clinical non-eligibility to the use of exoskeleton devices as per technical specifications of the devices
* Inability or difficulty in completing self-report measures in Italian and/or secondary illiteracy;
* Presence of psychiatric pathology in medical history or recent psychiatric pathology that could affect reliability of data collected;
* Refusal or withdrawal of informed consent at any stage of the study.
Caregivers
* Inability or difficulty in understanding Italian language and/or illiteracy;
* Refusal or withdrawal of informed consent at any stage of the study
Therapists
* Physiotherapists who partially assist enrolled patients throughout the entire intervention period
Study 2 (ID: RM-2024-803)
Therapists
* Refusal or withdrawal of informed consent at any stage of the study
18 Years
ALL
No
Sponsors
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University of Milan
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
University of Milano Bicocca
OTHER
Responsible Party
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Marco D'Addario
Associate Professor
Principal Investigators
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Patrizia Steca, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milano Bicocca
Marco D'Addario, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milano Bicocca
Alessandra Gorini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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University of Milano-Bicocca
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Marco D'Addario
Role: primary
Other Identifiers
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RM-2024-803
Identifier Type: OTHER
Identifier Source: secondary_id
0025654/24
Identifier Type: -
Identifier Source: org_study_id