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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Multidisciplinary Traditional Rehabiltiation

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Technology-enhanced RehabilitationExperimental treatment 2 interventions
Group B: Standard RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline to 4-week follow-up
2

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)

Time frame
Baseline to 4-week follow-up
3

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).

Time frame
Baseline to 4-week follow-up
4

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).

Time frame
Baseline to 4-week follow-up

Secondary outcomes

1

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.

Time frame
Baseline to 4-week follow-up (Repeated measures throughout the trial)
2

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)

Time frame
Baseline
3

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)

Time frame
Baseline to 4-week follow-up
4

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)

Time frame
4-week follow-up

Other outcomes

Sponsors and contacts

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University of Milano Bicocca

Lead sponsor

University of Milan

Collaborator

Istituti Clinici Scientifici Maugeri SpA

Collaborator

Source ClinicalTrials.gov
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