- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07582497
Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease (HOME VR REHAB)
Telerehabilitation in a Virtual Environment for Sensorimotor and Cognitive Recovery in Patients With Post-stroke Sequelae and Parkinson's Disease: a Pilot Study
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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Giada Lullini
- Telefonnummer: +393394958751
- E-mail: giada.lullini@isnb.it
Studiesteder
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BO
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Bologna, BO, Italien, 40193
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
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Kontakt:
- Giada Lullini
- Telefonnummer: +393394958751
- E-mail: giada.lullini@isnb.it
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Telerehabilitation with Immersive Virtual Reality (TR Group)
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.
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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.
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Aktiv komparator: Conventional Rehabilitation (Control Group)
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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Adherence rate to the telerehabilitation protocol
Tidsramme: End of treatment (T1, Week 4)
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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.
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End of treatment (T1, Week 4)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Berg Balance Scale (BBS)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Timed Up and Go Test (TUG)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Falls Efficacy Scale (FES)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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10-Meter Walk Test (10-MWT)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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6-Minute Walk Test (6-MWT)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Barthel Index (BI)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Trail Making Test (TMT)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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15-Word Memory Test (15-WMT)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Corsi Span Test (CS)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Digit Span Test (DS)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Short Form Health Survey-36 (SF-36)
Tidsramme: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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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.
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Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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Patient satisfaction with the VR-based telerehabilitation system (CSQ-8)
Tidsramme: Post-treatment (T1, Week 4)
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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.
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Post-treatment (T1, Week 4)
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Perceived usability of the VR-based telerehabilitation system (SUS)
Tidsramme: Post-treatment (T1, Week 4)
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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.
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Post-treatment (T1, Week 4)
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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