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

NCT06489145 | Recruiting

• 2 other identifiers: 0025654/24RM-2024-803
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Stroke Rehabilitation; Technology; Cognition; Quality of Life; Well-Being; Experience of Use

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (6)

• Change in Patient's Subjective Rehabilitation Experience

  Baseline to 4-week follow-up (Repeated measures throughout the trial)

• Rehabilitation Outcomes Expectations

  Baseline

• Satisfaction with Rehabilitation Treatment

  Baseline to 4-week follow-up

• Technology Perceived Usability

  4-week follow-up

• Technology Acceptance

  4-week follow-up

Study Arms (2)

Technology-enhanced Rehabilitation

EXPERIMENTAL

Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment.

Device: Technology-enhanced Rehabilitation; Other: Multidisciplinary Traditional Rehabiltiation

Standard Rehabilitation

ACTIVE COMPARATOR

Patients will participate in multidisciplinary traditional treatment only

Other: Multidisciplinary Traditional Rehabiltiation

Interventions

Technology-enhanced Rehabilitation DEVICE

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.

Technology-enhanced Rehabilitation

Multidisciplinary Traditional Rehabiltiation OTHER

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; Technology-enhanced Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;
• 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 assist enrolled patients throughout the entire intervention period
• Physiotherapists who partially assist enrolled patients throughout the entire intervention period
• Study 2 (ID: RM-2024-803)
• Therapists
• Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;

Sponsors & Collaborators

• University of Milano Bicocca: lead
• University of Milan: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

University of Milano-Bicocca

Milan, 20126, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrizia Steca, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

• Marco D'Addario, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

• Alessandra Gorini, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco D'Addario, PhD

CONTACT

02 6448 3824; marco.daddario@unimib.it

Francesco Zanatta, PhD

CONTACT

francesco.zanatta@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: June 24, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-07

Locations

IT (1)