Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients (ITER)

Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach

Through a multi-method, multi-informant, and patient-centred approach, the study aims to investigate the experience of use and the effectiveness of rehabilitation technology (robotics and virtual reality - VR) in post-stroke patients and their caregivers and therapists

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Technology-enhanced Rehabilitation; Other: Multidisciplinary Traditional Rehabiltiation

Detailed Description

The present research will consist of two parallel studies.

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco D'Addario, PhD; Phone Number: 02 6448 3824; Email: marco.daddario@unimib.it
• Study Contact Backup: Name: Francesco Zanatta, PhD; Email: francesco.zanatta@unimib.it

Study Locations

• Italy
  • Milan, Italy, 20126
    • Recruiting
    • University of Milano-Bicocca
    • Contact: Marco D'Addario; Phone Number: 02 6448 3824; Email: marco.daddario@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Study 1 (ID: 0025654/24)

Patients

Inclusion Criteria:

• Acute stroke event occurring within a maximum of 12 months prior to treatment;
• 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

Exclusion Criteria:

• Severe clinical condition (e.g., cognitive impairment - MMSE score < 24), presence of sever apraxia, complete upper limbs hemiplegia, severe upper limb sensory disorders, joint fractures and dislocations);
• 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

Inclusion Criteria:

• Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;

Exclusion Criteria:

• Inability or difficulty in understanding Italian language and/or illiteracy;
• Refusal or withdrawal of informed consent at any stage of the study

Therapists

Inclusion Criteria:

• Physiotherapists who assist enrolled patients throughout the entire intervention period

Exclusion Criteria:

• Physiotherapists who partially assist enrolled patients throughout the entire intervention period

Study 2 (ID: RM-2024-803)

Therapists

Inclusion Criteria:

• Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;

Exclusion Criteria:

• Refusal or withdrawal of informed consent at any stage of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technology-enhanced Rehabilitation; Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment.	Device: 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.; Other: 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.
Active Comparator: Standard Rehabilitation; Patients will participate in multidisciplinary traditional treatment only	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-post Intervention Change in Motor impairment	Changes will be assessed with the Motricity Index (MI). Higher scores indicate lower motor impairment in terms of muscle strength and upper and lower limbs motricity (range: 0-33).	Baseline to 4-week follow-up
Pre-post Intervention Change in Spasticity	Changes will be assessed with the Asworth modified Scale (MAS). Higher scores indicate higher spasticity (range: 0-4 for each body part assessed)	Baseline to 4-week follow-up
Pre-post Intervention Change in upper limbs sensory and motor functions	Changes will be assessed with the Fugl-Meyer Upper Extremity Scale (FMUE). Higher scores indicate lower sensory-motor disability (Upper limb motor function, range: 0-66; lower limb motor function, range: 0-34; sensory function, range:0-24; balance, range: 0-14; joint range of motion, range: 0-44; joint pain, range:0-44).	Baseline to 4-week follow-up
Pre-post Intervention Change in Autonomy in Activities of Daily Living (ADLs)	Changes will be assessed with the Barthel Index Modified (BIM). Higher scores (range: 0-100) indicate higher autonomy levels in ADLs (chair/bed transfer, ambulation, stair climbing, toilet transfer, bowel control, bladder control, bathing, dressing, personal hygiene, feeding).	Baseline to 4-week follow-up
Pre-post Intervention Change in Functional Disability	Changes will be assessed with the Functional Independence Measure (FIM), which includes two sub-scales evaluating motor (range: 13-91) and cognitive (range: 5-35) domains in relation to disability. Higher scores indicate lower levels of motor and cognitive disability.	Baseline to 4-week follow-up
Pre-post Intervention Change in global cognition	Changes will be assessed with the Mini Mental State Examination (MMSE), which includes sub-scores on temporal and spatial orientation, attention, executive functions, memory, language, and visual-spatial abilities. Higher scores indicate better global cognitive functioning (range: 0-30)	Baseline to 4-week follow-up
Pre-post Intervention Change in Long-term Verbal Memory	Changes will assessed with the Rey Auditory Verbal Memory Test (RAVLT). Higher scores indicate better long-term verbal memory functioning (range: 0-15)	Baseline to 4-week follow-up
Pre-post Intervention Change in Short-term Verbal Memory	Changes will be assessed with the Digit Span Task (DST). Higher scores indicate better short-term verbal memory functioning (range: 3-9)	Baseline to 4-week follow-up
Pre-post Intervention Change in Long-term Visual-spatial Memory	Changes will be assessed with the Rey-Osterrieth Complex Figure Test. Higher scores indicate better long-term visual.spatial memory functioning (range: 0-36)	Baseline to 4-week follow-up
Pre-post Intervention Change in Short-term Visual-spatial Memory	Changes will be assessed with the Corsi Block-Tapping Test. Higher scores indicate better short-term visual-spatial memory functioning (range: 3-9)	Baseline to 4-week follow-up
Pre-post Intervention Change in Visual-Spatial Attention	Changes will be assessed with the Multiple Features Target Cancellation (MFTC) test. Higher scores indicate better attentional and visual search abilities (range: 0-13)	Baseline to 4-week follow-up
Pre-post Intervention Change in Executive Functions	Changes will be assessed with the Trail Making Test (TMT). Higher time scores (i.e., seconds) indicate worse divided attention, cognitive flexibility, shifting and visual-motor coordination functions	Baseline to 4-week follow-up
Pre-post Intervention Change in Verbal Fluency	Changes will be assessed with Phonemic and Semantic Verbal Fluency tests. Higher scores (i.e., number of words) indicated better linguistic and verbal fluency functions	Baseline to 4-week follow-up
Pre-post Intervention Change in Perceived Health Status	Changes will be assessed with the EuroQoL Visual Analogue Scale (EQ-VAS). Higher scores indicate better perceived health status (range: 0-100)	Baseline to 4-week follow-up
Pre-post Intervention Change in Perceived Health-related Quality of Life	Changes will be assessed with the Short-Form Health Survey-12 (SF-12). Higher scores in bot sub-scales (Mental Health and Physical Health) indicate better perceived health-related quality of life (range: 0-100)	Baseline to 4-week follow-up
Pre-post Intervention Change in Anxiety and Depression Symptoms	Changes will be assessed with the Hospital Anxiety and Depression Scale (HADS). Higher scores indicated more severe anxiety and depression symptoms (range: 0-21)	Baseline to 4-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient's Subjective Rehabilitation Experience	Changes will be monitored through Ecological Momentary Assessment (EMA) method. Patients will be asked to fill out a daily diary after each therapy session and indicate their rehabilitation experience in terms of engagement, motivation, enjoyment and satisfaction. Selected items from the Intrinsic Motivation Inventory (IMI) will be administered. Higher scores indicate better subjective rehabilitation experience.	Baseline to 4-week follow-up (Repeated measures throughout the trial)
Rehabilitation Outcomes Expectations	Expectations will be assessed with the Expectancy sub-scale of the Credibility/Expectancy Questionnaire (CEQ). The assessment will be carried out on patients, their caregivers and therapists. Higher scores indicate more positive expectations on rehabilitation outcomes (range: 0-100)	Baseline
Satisfaction with Rehabilitation Treatment	Satisfaction levels in patients' caregivers will be assessed with Involvement practices scale. Higher scores indicate more positive caregiver's perception of information giving from rehabilitation staff, involvement in decision-making, and training to collaborate (range: 0-30)	Baseline to 4-week follow-up
Technology Perceived Usability	Perceived usability of the technological devices implemented will be assessed with the System Usability Scale (SUS). Higher scores indicate better technological device usability (range: 0-100)	4-week follow-up
Technology Acceptance	Acceptance will be assessed with the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). Higher scores indicate higher technology acceptance in terms of engagement levels, usability, distress and perceived hindrance (range: 31-124)	4-week follow-up
Technology Psychosocial Impact	Psychosocial impact will be assessed with the Psychosocial Impact of Assistive Device Scale (PIADS). Higher scores indicate better impact on patient's perceived adaptability (range: -18/+18), ability (range: -36/+36), and self-esteem (range: -24/+24).	4-week follow-up

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: University of Milan; Istituti Clinici Scientifici Maugeri SpA
• Investigators: Principal Investigator: Marco D'Addario, PhD, University of Milano Bicocca; Principal Investigator: Patrizia Steca, PhD, University of Milano Bicocca; Principal Investigator: Alessandra Gorini, PhD, University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Cognition; Technology; Stroke Rehabilitation; Well-Being; Experience of Use
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 0025654/24; RM-2024-803 (Other Identifier: University of Milano-Bicocca)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No