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

Browse trials for

• Stroke 7,443

Keywords

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

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Lead sponsor

University of Milano Bicocca is the lead sponsor of 126 studies on the registry; 47 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  Technology-enhanced Rehabilitation

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

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

• Active comparator
  Standard Rehabilitation

  Patients will participate in multidisciplinary traditional treatment only

  Other: Multidisciplinary Traditional Rehabiltiation

Interventions

• DeviceTechnology-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.

• OtherMultidisciplinary 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.

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

5. 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.

   Time frame: Baseline to 4-week follow-up

6. 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)

   Time frame: Baseline to 4-week follow-up

7. 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)

   Time frame: Baseline to 4-week follow-up

8. 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)

   Time frame: Baseline to 4-week follow-up

9. 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)

   Time frame: Baseline to 4-week follow-up

10. 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)

    Time frame: Baseline to 4-week follow-up

11. 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)

    Time frame: Baseline to 4-week follow-up

12. 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

    Time frame: Baseline to 4-week follow-up

13. 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

    Time frame: Baseline to 4-week follow-up

14. 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)

    Time frame: Baseline to 4-week follow-up

15. 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)

    Time frame: Baseline to 4-week follow-up

16. 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)

    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

5. 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)

   Time frame: 4-week follow-up

6. 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).

   Time frame: 4-week follow-up