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NCT Number: NCT07582497

Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease

The goal of this interventional pilot trial is to evaluate whether a telerehabilitation protocol based on immersive virtual reality (VR) is effective and feasible for the recovery of cognitive and/or motor functions in patients with sequelae of ischemic or hemorrhagic stroke or with Parkinson's disease.

The main questions it aims to answer are:

* Does the VR-based telerehabilitation protocol improve cognitive and/or motor outcomes compared to conventional rehabilitation? * Is the protocol feasible, defined as ≥80% adherence among participants? Is the system acceptable and user-friendly from the patient's perspective? Researchers will compare an interventional arm receiving telerehabilitation via an immersive VR home kit with a control arm receiving conventional rehabilitation according to standard clinical practice. Both groups will receive the same number of sessions, with the same duration and weekly frequency. Outcomes will be assessed at baseline (T0), after 4 weeks of treatment (T1), and at 3-month follow-up (T2).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, BO, 40193, Italy

Location contact

Giada Lullini

CONTACT

[email protected]

+393394958751

About this study

Telerehabilitation (TR) is defined as the remote delivery of rehabilitation services through telecommunications technologies. It offers particular advantages for patients with neurological disabilities who require continuous and personalized rehabilitation training, enabling flexible treatment protocols and ongoing clinical-functional monitoring, especially for those residing in remote areas or with limited mobility.

Immersive virtual reality (VR) represents a highly engaging environment in which multiple forms of sensory feedback-auditory, visual, and tactile-can be organized to activate cortical and subcortical neural structures, thereby promoting functional and structural recovery. Evidence on neuroplasticity suggests that immersive VR systems may represent a key element in rehabilitation programs by enhancing motor learning capacity. Through specialized devices, it is possible to recreate and simulate actions in an immersive virtual environment, allowing patients to experience safe and realistic scenarios with real-time responses to stimuli, eliciting physiological and neural activation comparable to real-world experiences.

In patients with stroke sequelae or Parkinson's disease, the combination of TR and immersive VR-compared to conventional therapeutic approaches-allows for interactive, task-specific treatment adapted to individual patient characteristics, delivered over extended periods with adequate patient engagement. This approach may have a positive neuropsychological impact in terms of disability acceptance and usability, improving functional outcomes and quality of life.

The experimental treatment group will perform a personalized cognitive and/or motor rehabilitation protocol using a certified Home Kit including an immersive VR headset, already employed in clinical practice at the coordinating center. After three in-person sessions for technology familiarization, patients will use the Home Kit at home for 50 minutes per day, 5 days per week, asynchronously, with one weekly synchronous session via videoconferencing with the therapist. Continuous remote monitoring of outcomes and timely adjustment of parameters will be ensured throughout the 4-week treatment period.

The control group will receive cognitive and/or motor rehabilitation according to standard clinical practice (individual rehabilitation program, 50-minute sessions, 5 days per week for 4 weeks).

Randomization will be performed by an external collaborator not involved in patient assessment or treatment, using a pre-generated randomization list to ensure allocation concealment.

Patients will be assessed at baseline (T0), at the end of the 4-week treatment (T1), and at 3-month follow-up (T2) using standardized clinical scales evaluating balance, fall risk, walking ability, upper limb impairment, activities of daily living, memory and attention, and quality of life. Acceptability and usability of the VR telerehabilitation system will be assessed at T1 in the experimental group only.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years old, both sex;
  • stroke or Parkinson diagnosis > or = 2 months;
  • upper limb impairment
  • informed consent signed

Exclusion criteria

  • ongoing clinical instability;
  • important cognitive impairment;
  • psychiatric, neurological, or internal medicine comorbidities;
  • severe rigidity or hypertonia;
  • severe visual deficit;
  • pregnancy women

Treatment and study plan

VR-based Telerehabilitation with Home Kit

Other

The proposed intervention uses a certified Home Kit - inclusive of an immersive VR headset - already employed in clinical practice at the coordinating center (IRCCS ISNB, Bologna). The rehabilitation team (physician, speech therapist, physiotherapist) defines an individualized protocol for cognitive and/or motor recovery. The first 3 sessions are conducted in-person to allow technology familiarization. Patients then use the Home Kit at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode. One weekly synchronous session via videoconference with the therapist is included. The Home Kit automatically records daily protocol execution, enabling continuous telemonitoring and timely adaptation of rehabilitation parameters.

Standard Rehabilitation (Conventional Care)

Other

Patients in the control group receive cognitive and/or motor rehabilitation according to standard clinical practice, as defined by the individual rehabilitation project. Sessions last 50 minutes, are delivered 5 days per week, for 4 weeks, and are conducted in person at the rehabilitation unit. No virtual reality or telerehabilitation technology is used in this arm.

Primary outcomes

  1. Adherence rate to the telerehabilitation protocol

    Time frame: End of treatment (T1, Week 4)

    Feasibility is defined as the proportion of participants in the TR group achieving ≥80% adherence to the prescribed daily rehabilitation sessions over the 4-week protocol. A participant is considered adherent if they complete at least 80% of scheduled sessions and both pre- and post-treatment assessments. Adherence is automatically recorded by the Home Kit device.

Secondary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of BBS scores (range 0-56; higher score indicates better performance) between the groups and within the experimental group. BBS assesses static and dynamic balance during functional daily activities and movements.

  2. Timed Up and Go Test (TUG)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of TUG scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. TUG measures functional mobility and fall risk by timing standing up, walking, turning, and sitting down.

  3. Falls Efficacy Scale (FES)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of FES scores (range 16-64; higher score indicates worse performance) between the groups and within the experimental group. FES evaluates fear of falling during activities of daily living.

  4. 10-Meter Walk Test (10-MWT)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of 10-MWT scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. 10-MWT measures walking speed over a distance of 10 meters.

  5. 6-Minute Walk Test (6-MWT)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of 6-MWT scores (distance in meters; higher score indicates better performance) between the groups and within the experimental group. 6-MWT assesses physical endurance and aerobic capacity by measuring the distance walked in 6 minutes.

  6. Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of FMA-UE scores (range 0-126; higher score indicates better performance) between the groups and within the experimental group. FMA-UE evaluates upper limb motor function after neurological impairment.

  7. Barthel Index (BI)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of BI scores (range 0-100; higher score indicates better performance) between the groups and within the experimental group. BI measures independence in basic activities of daily living.

  8. Trail Making Test (TMT)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of TMT scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. TMT assesses attention, processing speed, and cognitive flexibility.

  9. 15-Word Memory Test (15-WMT)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of 15-WMT scores (range 0-75; higher score indicates better performance) between the groups and within the experimental group. 15-WMT measures verbal memory and learning ability.

  10. Corsi Span Test (CS)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of CS scores (range 0-9; higher score indicates better performance) between the groups and within the experimental group. CS evaluates short-term visuospatial memory.

  11. Digit Span Test (DS)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of DS scores (range 0-9; higher score indicates better performance) between the groups and within the experimental group. DS measures working memory and the ability to retain numerical sequences.

  12. Short Form Health Survey-36 (SF-36)

    Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)

    Comparison of SF-36 scores (range 0-100; higher score indicates better performance) between the groups and within the experimental group. SF-36 assesses health-related quality of life in physical and mental domains.

  13. Patient satisfaction with the VR-based telerehabilitation system (CSQ-8)

    Time frame: Post-treatment (T1, Week 4)

    Assessment of patient satisfaction using the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979; score range 8-32; higher scores indicate greater satisfaction). Administered to the experimental group only.

  14. Perceived usability of the VR-based telerehabilitation system (SUS)

    Time frame: Post-treatment (T1, Week 4)

    Assessment of perceived usability using the System Usability Scale (SUS, Brooke, 1986; score range 0-100; higher scores indicate better usability). Administered to the experimental group only.

Study contacts

Contact information is provided by the study sponsor or research team.

Giada Lullini

CONTACT

[email protected]

+393394958751

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

Telerehabilitation in a Virtual Environment for Sensorimotor and Cognitive Recovery in Patients With Post-stroke Sequelae and Parkinson's Disease: a Pilot Study

Acronym: HOME VR REHAB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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