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

NCT07582497 | Not Yet Recruiting

• 1 other identifier: HOMEVIRTUAL REHAB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ictus; Stroke; Parkinson Disease

Keywords

upper limb impairment; teleneurorehabilitation; virtual reality; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence rate to the telerehabilitation protocol

  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.

  End of treatment (T1, Week 4)

Secondary Outcomes (14)

• Berg Balance Scale (BBS)

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

• Timed Up and Go Test (TUG)

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

• Falls Efficacy Scale (FES)

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

• 10-Meter Walk Test (10-MWT)

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

• 6-Minute Walk Test (6-MWT)

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

Study Arms (2)

Telerehabilitation with Immersive Virtual Reality (TR Group)

EXPERIMENTAL

Patients will receive an individualized cognitive and/or motor rehabilitation protocol via a certified Home Kit inclusive of an immersive VR headset. After 3 in-person familiarization sessions, patients will perform the rehabilitation program at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode with one weekly synchronous videoconference session with the therapist. Continuous telemonitoring and parameter adaptation will be provided throughout the treatment period.

Other: VR-based Telerehabilitation with Home Kit

Conventional Rehabilitation (Control Group)

ACTIVE COMPARATOR

Patients will receive cognitive and/or motor rehabilitation according to standard clinical practice, consisting of individual rehabilitation sessions of 50 minutes, 5 days per week, for 4 weeks, as defined by the individual rehabilitation project.

Other: Standard Rehabilitation (Conventional Care)

Interventions

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.

Telerehabilitation with Immersive Virtual Reality (TR Group)

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.

Conventional Rehabilitation (Control Group)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, BO, 40193, Italy

Location

Related Publications (16)

• Marin-Medina DS, Arenas-Vargas PA, Arias-Botero JC, Gomez-Vasquez M, Jaramillo-Lopez MF, Gaspar-Toro JM. New approaches to recovery after stroke. Neurol Sci. 2024 Jan;45(1):55-63. doi: 10.1007/s10072-023-07012-3. Epub 2023 Sep 11.

  PMID: 37697027 BACKGROUND

• Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.

  PMID: 31165721 BACKGROUND

• Kwon SH, Park JK, Koh YH. A systematic review and meta-analysis on the effect of virtual reality-based rehabilitation for people with Parkinson's disease. J Neuroeng Rehabil. 2023 Jul 20;20(1):94. doi: 10.1186/s12984-023-01219-3.

  PMID: 37475014 BACKGROUND

• Cano Porras D, Siemonsma P, Inzelberg R, Zeilig G, Plotnik M. Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review. Neurology. 2018 May 29;90(22):1017-1025. doi: 10.1212/WNL.0000000000005603. Epub 2018 May 2.

  PMID: 29720544 BACKGROUND

• Alashram AR, Annino G, Padua E, Romagnoli C, Mercuri NB. Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. J Clin Neurosci. 2019 Aug;66:209-219. doi: 10.1016/j.jocn.2019.04.026. Epub 2019 May 10.

  PMID: 31085075 BACKGROUND

• Aida J, Chau B, Dunn J. Immersive virtual reality in traumatic brain injury rehabilitation: A literature review. NeuroRehabilitation. 2018;42(4):441-448. doi: 10.3233/NRE-172361.

  PMID: 29660958 BACKGROUND

• Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.

  PMID: 27124611 BACKGROUND

• De Luca R, Maggio MG, Naro A, Portaro S, Cannavo A, Calabro RS. Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. J Clin Neurosci. 2020 Sep;79:246-250. doi: 10.1016/j.jocn.2020.07.063. Epub 2020 Aug 17.

  PMID: 33070905 BACKGROUND

• Ownsworth T, Arnautovska U, Beadle E, Shum DHK, Moyle W. Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2018 Jul/Aug;33(4):E33-E46. doi: 10.1097/HTR.0000000000000350.

  PMID: 29084100 BACKGROUND

• Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.

  PMID: 30649091 BACKGROUND

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

• Luque-Moreno C, Ferragut-Garcias A, Rodriguez-Blanco C, Heredia-Rizo AM, Oliva-Pascual-Vaca J, Kiper P, Oliva-Pascual-Vaca A. A Decade of Progress Using Virtual Reality for Poststroke Lower Extremity Rehabilitation: Systematic Review of the Intervention Methods. Biomed Res Int. 2015;2015:342529. doi: 10.1155/2015/342529. Epub 2015 Oct 11.

  PMID: 26539480 BACKGROUND

• Maresca G, Maggio MG, De Luca R, Manuli A, Tonin P, Pignolo L, Calabro RS. Tele-Neuro-Rehabilitation in Italy: State of the Art and Future Perspectives. Front Neurol. 2020 Sep 30;11:563375. doi: 10.3389/fneur.2020.563375. eCollection 2020.

  PMID: 33101176 BACKGROUND

• Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13. doi: 10.1177/1357633X15572201. Epub 2015 Feb 22.

  PMID: 25712109 BACKGROUND

• Wootton R, Bahaadinbeigy K, Hailey D. Estimating travel reduction associated with the use of telemedicine by patients and healthcare professionals: proposal for quantitative synthesis in a systematic review. BMC Health Serv Res. 2011 Aug 8;11:185. doi: 10.1186/1472-6963-11-185.

  PMID: 21824388 BACKGROUND

• Hakansson S, Gavelin C. What do we really know about the cost-effectiveness of telemedicine? J Telemed Telecare. 2000;6 Suppl 1:S133-6. doi: 10.1258/1357633001934438.

  PMID: 10793998 BACKGROUND

MeSH Terms

Conditions

Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Giada Lullini

CONTACT

+393394958751; giada.lullini@isnb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 13, 2026
• Study Start: June 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)