SwissNeuroRehab - HDHI (SNR-HDHI)

SwissNeuroRehab - High Dose High Intensity Neurorehabilitation Along the Continuum of Care

High-dose, high-intensity (HDHI) neurorehabilitation has shown promise for improving functional outcomes after acquired brain injury (ABI), yet its feasibility and impact across different stages of care and real-world clinical settings remain insufficiently understood.

The SwissNeuroRehab (SNR) initiative, bringing together Swiss rehabilitation centres to develop and evaluate innovative, technology-supported models of neurorehabilitation, provides the broader framework within which this study is conducted.

Within this framework, a structured HDHI therapy pathway supported by CE-marked digital neurorehabilitation tools has been developed for delivery across inpatient, outpatient, and home environments in Switzerland.

This multicentre, non-randomised interventional feasibility study evaluates the feasibility and preliminary clinical effects of implementing this HDHI rehabilitation pathway for adults with stroke in subacute and chronic stages. Participants will receive approximately 300 minutes per week of active, technology-supported training in addition to standard rehabilitation care, following an individually tailored pathway across settings. Standardised clinical assessments, patient-reported outcomes, documentation of rehabilitation procedures, and socioeconomic measures will be collected at baseline, discharge, and follow-up timepoints up to 12-15 months post-enrollment.

The primary aim of the study is to assess the feasibility of the HDHI intervention within routine rehabilitation workflows across multiple Swiss centres. Feasibility will be evaluated through (i) adherence to at least half of the weekly 300-minute Active Training Time target and (ii) patients' perceived feasibility and satisfaction with the program.

Secondary aims are to explore preliminary clinical and functional changes, patient-reported outcomes, and quantify socioeconomic impacts through dedicated surveys and cost data.

Findings from this study will (i) determine whether a structured HDHI rehabilitation pathway can be feasibly implemented across diverse clinical contexts, (ii) provide initial estimates of clinical and socioeconomic outcomes to support planning of future controlled trials.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Device assisted high-dose therapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier Bill, MD; Phone Number: +41 0213141260; Email: olivier.bill@chuv.ch
• Study Contact Backup: Name: Andrea Serino, Prof.; Phone Number: +41 21 314 3996; Email: andrea.serino@chuv.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Vitznau, Canton of Lucerne, Switzerland, 6354
      • Not yet recruiting
      • Lake Lucerne Institute
      • Contact: Christoph Bauer, PhD.; Phone Number: +41 79 527 24 49; Email: christoph.bauer@llui.org
      • Principal Investigator: Christoph Bauer, PhD
  • Canton of St. Gallen
    • Valens, Canton of St. Gallen, Switzerland, 7317
      • Recruiting
      • Klinik Valens
      • Contact: Jens Bansi, Dr.; Phone Number: +41 585101302; Email: jens.bansi@kliniken-valens.ch
      • Principal Investigator: Jens Bansi, Dr.
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois
      • Contact: Olivier Bill; Phone Number: +41 0213141260; Email: olivier.bill@chuv.ch
      • Principal Investigator: Olivier Bill, MD
    • Sullens, Canton of Vaud, Switzerland, 1036
      • Recruiting
      • Swiss Réhabilitation Sàrl
      • Contact: Nicolas Perret; Phone Number: +41 021 866 66 75; Email: nicolas.perret@hesav.ch
      • Principal Investigator: Nicolas Perret
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8006
      • Not yet recruiting
      • UniversitätSpital Zürich
      • Contact: Andreas Luft, Prof.; Phone Number: +41 0798626436; Email: andreas.luft@usz.ch
      • Principal Investigator: Andreas Luft, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-85 years.
• Confirmed diagnosis of stroke (ischemic or hemorrhagic) >7 days ago
• Be able to sit unassisted
• Able and willing to give informed consent
• Have motor difficulties of the Upper Extremity and/or Lower Extremity
• Willing to commit to program length & daily training dose
• Willing to have assessments at start and end of program
• Signed informed consent

Exclusion Criteria:

• Severe cognitive impairment
• Uncontrolled seizure disorder or epilepsy - clinician's judgement)
• Any medical condition that would compromise their safety (inability to communicate, vision or hearing impairment, heart condition that limits participation in exercise) and tolerability (cardiac contraindications)
• Pain that would limit rehabilitation dose
• Severe apraxia
• Severe memory disorder
• Severe hemispatial neglect
• Plegia of the affected limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device assisted high-dose therapy; Participants receive a high-dose, high-intensity (HDHI) motor rehabilitation program supported by digital therapeutic devices, delivered across inpatient, outpatient and home-based settings.

Behavioral: Device assisted high-dose therapy; Participants undergo a high-dose, high-intensity (HDHI) neurorehabilitation program using CE-marked digital therapeutic devices (MindMotion GO, Izar). The intervention is tailored to individual motor rehabilitation needs and delivered across settings: during inpatient rehabilitation (4-6 weeks) and/or home-based outpatient care (8-12 weeks). Participants are expected to train actively for approximately one hour per day (5day week), supported by clinical staff and if applicable, caregivers.The intervention is supervised by clinical teams specifically trained in the HDHI protocol, who provide ongoing therapeutic support and monitor progress across settings.; Other Names: Device assisted high-dose neurorehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDHI training adherence (Active Training Time, ATT)	The adherence to ≥150 minutes per week of Active Training Time (ATT), corresponding to at least half of the predefined weekly target of 300 minutes/week. ATT is derived from device-recorded active training logs and aggregated by calendar week during the intervention period. Weekly ATT is summarized across the intervention period to determine whether participants meet the predefined weekly adherence criterion.	Weekly during the intervention period (up to 18 weeks)
Feasibility and satisfaction with the HDHI program (Program Feasibility and Satisfaction Questionnaire)	The perceived feasibility and patient satisfaction with the HDHI program, assessed using a study-specific Program Feasibility and Satisfaction Questionnaire consisting of 12 Likert-scale items covering accessibility/ease of use, pleasant content, empowerment capability, self-efficacy, alignment with clinical objectives, alignment with personal values and culture, environmental context, trust in the program, and perceived personal value. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A total score is calculated by summing item scores, with a minimum possible score of 12 and a maximum possible score of 60; higher scores indicate greater perceived feasibility and satisfaction.	At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)	Upper-limb motor impairment measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The motor domain of the FMA-UE consists of 33 items assessing upper-limb motor function, with a total score ranging from 0 to 66; higher scores indicate better motor function and less motor impairment.	From baseline to follow-up assessments up to 15 months post-inclusion
Action Research Arm Test (ARAT)	Upper-limb functional performance measured using the Action Research Arm Test (ARAT). The ARAT consists of 19 items across grasp, grip, pinch, and gross movement domains, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 57; higher scores indicate better upper-limb functional performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Extended Barthel Index (eBI)	Activities of daily living performance measured using the Extended Barthel Index (eBI). The eBI assesses functional independence in activities of daily living using a 16-item scale, with a total score ranging from 0 to 64; higher scores indicate greater independence and better activities of daily living performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Functional Independence Measure (FIM)	Functional independence measured using the Functional Independence Measure (FIM). The FIM is an 18-item scale assessing independence in activities of daily living, with each item scored from 1 to 7, resulting in a total score ranging from 18 to 126; higher scores indicate greater functional independence.	From baseline to follow-up assessments up to 15 months post-inclusion
Modified Rankin Scale (mRS)	Global disability measured using the Modified Rankin Scale (mRS). The mRS is a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death), used to assess the level of functional disability and dependence in daily activities; higher scores indicate greater disability and worse functional outcome.	From baseline to follow-up assessments up to 15 months post-inclusion
Grip Strength - Hand Dynamometry	Grip strength of the affected hand measured using a Jamar hand dynamometer. Maximum voluntary grip strength is recorded in kilograms (kg), calculated as the mean of three trials; higher values indicate greater grip strength.	From baseline to follow-up assessments up to 15 months post-inclusion
Mini Balance Evaluation Systems Test (Mini-BESTest)	Balance performance measured using the Mini Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest consists of 14 items, each scored from 0 to 2, assessing dynamic balance across anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait, with a total score ranging from 0 to 28; higher scores indicate better balance performance.	From baseline to follow-up assessments up to 15 months post-inclusion
10-Meter Walk Test (10mWT)	Gait speed measured using the 10-Meter Walk Test (10mWT) performed at self-selected walking speed. Gait speed is calculated in meters per second (m/s); higher values indicate faster walking speed and better gait performance.	From baseline to follow-up assessments up to 15 months post-inclusion
6-Minute Walk Test (6MWT)	Gait endurance measured using the 6-Minute Walk Test (6MWT). Endurance is quantified as the total distance walked in meters during the 6-minute test period; higher values indicate greater walking endurance and better gait performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Timed Up and Go test (TUG)	Functional mobility measured using the Timed Up and Go test (TUG). Performance is quantified as the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down, measured in seconds (s); lower values indicate better functional mobility.	From baseline to follow-up assessments up to 15 months post-inclusion
Five Times Sit-to-Stand test (5xSTS)	Lower-limb functional strength and balance measured using the Five Times Sit-to-Stand test (5xSTS). Performance is quantified as the time required to stand up from and sit down on a chair five times consecutively, measured in seconds (s); lower values indicate better lower-limb functional performance.	From baseline to follow-up assessments up to 15 months post-inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC)	Participant's global perception of change in overall health status measured using the Patient Global Impression of Change (PGIC) scale. The PGIC is a 7-point ordinal scale ranging from 1 (very much worse) to 7 (very much improved); higher scores indicate greater perceived improvement.	At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion
Pain Visual Analog Scale (VAS)	Self-reported pain intensity measured using a Visual Analog Scale (VAS). Pain intensity is rated on a numeric scale ranging from 0 (no pain) to 100 (worst pain imaginable); higher scores indicate greater pain intensity.	From baseline to follow-up assessments up to 12 months post-discharge
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses health status across five dimensions, each rated on five ordered levels (1 = no problems to 5 = extreme problems). Responses are combined to derive an EQ-5D-5L index score; higher index values indicate better health-related quality of life.	From baseline to follow-up assessments up to 12 months post-discharge
PROMIS Global-10	Self-reported global physical and mental health status measured using the PROMIS Global Health (Global-10) questionnaire. The instrument yields two summary scores: Global Physical Health (GPH) raw score and Global Mental Health (GMH) raw score. Each summary score has a raw score range from 4 to 20; higher scores indicate better health status.	From baseline to follow-up assessments up to 12 months post-discharge
Short Form Stroke Impact Scale (SF-SIS)	Stroke-specific impact on daily life and participation measured using the Short Form Stroke Impact Scale (SF-SIS). The SF-SIS is a patient-reported questionnaire assessing the perceived impact of stroke on physical function, activities, cognition, communication, emotion, and participation using ordered response categories; higher scores indicate better function and less perceived impact of stroke.	From baseline to follow-up assessments up to 12 months post-discharge
Falls and sleep-related outcomes (modified questionnaire)	Self-reported occurrence of falls and sleep-related characteristics assessed using a study-specific modified falls and sleep questionnaire. Falls outcomes include the number of falls, number of falls resulting in injury, and number of falls requiring hospitalisation during the preceding month. Sleep-related outcomes include self-reported interference of sleep problems with daily functioning, assessed using an ordinal response scale, where higher ratings indicate greater interference.	From baseline to follow-up assessments up to 12 months post-discharge
Behavioral Risk Factor Surveillance System (BRFSS) items	Health-related risk and well-being characteristics assessed using selected items from the Behavioral Risk Factor Surveillance System (BRFSS). Outcomes include the number of days in the past 30 days during which participants report poor physical health, poor mental health, and activity limitation due to poor physical or mental health, recorded as counts of days (0-30). Higher values indicate a greater number of unhealthy days.	From baseline to follow-up assessments up to 12 months post-discharge
Socio-Economic Status and Health Resource Use	Socio-economic characteristics and health resource use assessed using a study-specific structured socio-economic questionnaire and rehabilitation-related resource use data. Variables include employment status, living situation, support needs, and use of rehabilitation and healthcare services, reported descriptively.	Socio-economic questionnaire: From baseline to follow-up assessments up to 15 months post-inclusion Administrative health resource use data: Annually, for the duration of study participation
Standard of Care and Exercise Exposure	Exposure to standard rehabilitation care and additional physical exercise assessed using a study-specific structured questionnaire and/or exercise diary. Variables include the type, frequency, and duration of rehabilitation and physical activities performed outside the HDHI program, reported descriptively.	During study participation, assessed retrospectively at discharge and follow-up assessments up to 15 months post-inclusion
Program delivery feasibility	Feasibility of HDHI program delivery assessed using program-specific documentation, including enrollment records, completion status, and discharge documentation. Feasibility outcomes include the number and proportion of participants who initiate the program, complete the intervention, and discontinue prematurely, reported descriptively.	From program initiation through completion of the intervention (up to 18 weeks)
Training dose delivery	Training dose delivery assessed using device-recorded session logs. Outcomes include total active training time, number of completed sessions, and distribution of training across modalities, summarized descriptively over the intervention period.	During the intervention period (up to 18 weeks)
Systolic Blood Pressure	Systolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures.	From baseline to follow-up assessments up to 15 months post-inclusion.
Diastolic blood pressure	Diastolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures.	From baseline to follow-up assessments up to 15 months post-inclusion
Heart Rate	Heart rate measured in beats per minute (bpm) using standard clinical procedures.	From baseline to follow-up assessments up to 15 months post-inclusion
Peripheral oxygen saturation (SpO₂)	Peripheral oxygen saturation measured as percentage of hemoglobin oxygen saturation (%) using pulse oximetry.	From baseline to follow-up assessments up to 15 months post-inclusion
Digit Span Backward	Working memory domain: Verbal working memory involving mental manipulation, assessed using the Digit Span Backward task. Performance is reported as a standardized score derived from test norms (e.g., T-score), with higher scores indicating better working memory performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Trail Making Test Part A (TMT-A)	Non-lateralized attention (processing speed domain): visual scanning and psychomotor processing speed assessed using the Trail Making Test Part A. Performance is reported using standardized scores based on completion time, with higher scores indicating better performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Trail Making Test Part B(TMT-B)	Executive function domain: cognitive flexibility and set shifting assessed using the Trail Making Test Part B under speeded visuomotor conditions. Performance is reported using standardized scores, with higher scores indicating better cognitive flexibility.	From baseline to follow-up assessments up to 15 months post-inclusion
Color Trails Test 1	Non-lateralized attention (processing speed domain): visual scanning and psychomotor processing speed assessed using the Color Trails Test Part 1. The Color Trails Test is used as a language-reduced alternative to the Trail Making Test Part A in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from test norms, with higher scores indicating better performance.	From baseline to follow-up assessments up to 15 months post-inclusion
Color Trails Test 2	Executive function domain: cognitive flexibility and set shifting assessed using the Color Trails Test Part 2 under speeded visuomotor conditions. The Color Trails Test is used as a language-reduced alternative to the Trail Making Test Part B in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from test norms, with higher scores indicating better cognitive flexibility.	From baseline to follow-up assessments up to 15 months post-inclusion
Five-Point Test (5PT)	Executive function domain: figural fluency assessed using the Five-Point Test, reflecting nonverbal generative fluency and self-monitoring. Performance is reported as a standardized score derived from the number of unique designs produced, with higher scores indicating better figural fluency.	From baseline to follow-up assessments up to 15 months post-inclusion
Phonemic Fluency	Executive function domain: phonemic verbal fluency assessed by the ability to generate words according to phonemic constraints within a fixed time period. Performance reflects executive control of lexical retrieval and self-monitoring and is reported as a standardized score, with higher scores indicating better phonemic fluency.	From baseline to follow-up assessments up to 15 months post-inclusion
Semantic Fluency	Executive function domain: semantic verbal fluency assessed by the ability to generate words within a semantic category during a fixed time period. Performance primarily reflects semantic memory retrieval supported by executive control processes and is reported as a standardized score, with higher scores indicating better semantic fluency.	From baseline to follow-up assessments up to 15 months post-inclusion
Stroop Test	Executive function domain: interference control assessed using the Stroop Color-Word Test. Performance reflects the ability to resolve cognitive interference under competing stimulus conditions and is reported as a standardized score derived from response time and error measures, with higher scores indicating better interference control.	From baseline to follow-up assessments up to 15 months post-inclusion
TAP Go/No-Go	Executive function domain: motor response inhibition assessed using the Go/No-Go subtest of the Test of Attentional Performance (TAP). This task is used as a language-independent alternative to the Stroop test in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from error rates and reaction time measures, with higher scores indicating better response inhibition.	From baseline to follow-up assessments up to 15 months post-inclusion
TAP Alertness	Non-lateralized attention domain: tonic alertness assessed using the Alertness subtest of the Test of Attentional Performance (TAP). Performance reflects baseline response readiness and is reported as a standardized score derived from reaction time measures, with higher scores indicating better alertness.	From baseline to follow-up assessments up to 15 months post-inclusion
TAP Divided Attention	Non-lateralized attention domain: divided attention assessed using the Divided Attention subtest of the Test of Attentional Performance (TAP). Performance reflects the ability to allocate attentional resources across concurrent tasks and is reported as a standardized score derived from reaction time and/or error measures, with higher scores indicating better divided attention.	From baseline to follow-up assessments up to 15 months post-inclusion
TAP Shift of Focus	Executive-attentional domain: attentional flexibility assessed using the Shift of Focus (Flexibility) subtest of the Test of Attentional Performance (TAP). Performance reflects the ability to shift attentional focus between task-relevant stimuli and is reported as a standardized score derived from reaction time and/or error measures, with higher scores indicating better attentional flexibility.	From baseline to follow-up assessments up to 15 months post-inclusion
Apples Test	Lateralized attention domain: visuospatial attention bias assessed using the Apples Test, which dissociates egocentric and allocentric spatial attention deficits. Performance is reported using standardized asymmetry indices derived from cancellation accuracy, with greater symmetry indicating better spatial attention.	From baseline to follow-up assessments up to 15 months post-inclusion
Working Memory Questionnaire (WMQ)	Working memory domain: Self-reported working-memory-related difficulties in everyday functioning assessed using a standardized Working Memory Questionnaire. Scores are reported according to the questionnaire scoring manual, with higher scores indicating greater perceived working-memory difficulties.	From baseline to follow-up assessments up to 15 months post-inclusion
Hospital Anxiety and Depression Scale (HADS)	Depression and anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire with two 7-item subscales (Anxiety and Depression). Each item is scored 0-3; subscale scores range 0-21 and total score ranges 0-42, with higher scores indicating greater symptom severity.	From Baseline to follow-up assessments up to 15 months post-inclusion
Fatigue Scale for Motor and Cognitive Functions (FSMC)	Fatigue assessed using the Fatigue Scale for Motor and Cognitive Functions (FSMC), a 20-item self-report questionnaire comprising motor and cognitive fatigue subscales. Items are rated on an ordered response scale, and subscale and total scores are calculated according to the scoring manual, with higher scores indicating greater fatigue severity.	From baseline to follow-up assessments up to 15 months post-inclusion
Modified Ashworth Scale (MAS)	Spasticity assessed using the Modified Ashworth Scale (MAS) for specified joints (shoulder, elbow, wrist, hip, knee, ankle, fingers). MAS is scored on an ordinal scale (0, 1, 1+, 2, 3, 4), where higher scores indicate greater resistance to passive movement (greater spasticity).	From baseline to follow-up assessments up to 15 months post-inclusion.
Muscle Strength Testing (MST)	Voluntary muscle strength assessed using manual Muscle Strength Testing (MST) of upper and lower limbs according to standardized site procedures. Muscle strength is recorded as ordinal strength grades for predefined muscle groups of the upper and lower extremities, with higher grades indicating greater muscle strength.	From baseline to follow-up assessments up to 15 months post-inclusion
Digit Span Forward	Memory domain: Verbal short-term memory and attention span, assessed using the Digit Span Forward task. Performance is defined as the maximum correctly recalled digit sequence length; Performance is reported as a standardized score derived from test norms (e.g., T-score).	From baseline to follow-up assessments up to 15 months post-inclusion
Block Span (Corsi Block-Tapping Test)	Memory domain: Visuospatial short-term memory, assessed using the Block Span (Corsi Block-Tapping) Test. Performance is reported as a standardized score based on normative data, with higher scores indicating better visuospatial working memory.	From baseline to follow-up assessments up to 15 months post-inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Mindmaze SA; Cereneo AG; Innosuisse - Swiss Innovation Agency
• Investigators: Study Chair: Andrea Serino, Prof., Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Sokolov AA, Serino A. SWISSNEUROREHAB - Technologie-assistiertes Continuum of Care in der Schweizer Neurorehabilitation. Neurol Rehabil. 2024;30(S1):28-29

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: high dose; intensive therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Therapeutics; Neurological Rehabilitation
• Other Study ID Numbers: BPR1243; 2025-00413 (Other Identifier: CER-VD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No