SwissNeuroRehab - HDHI
NCT07427511, Not applicable, Recruiting, Centre Hospitalier Universitaire Vaudois
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | SwissNeuroRehab - HDHI | ClinicalTrials.gov |
| NCT number | NCT07427511 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier Universitaire Vaudois | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | Device assisted high-dose therapy | ClinicalTrials.gov |
| First posted | 2026-02-23 | ClinicalTrials.gov |
| Last updated | 2026-03-10 | ClinicalTrials.gov |
Registered outcomes 49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | HDHI training adherence (Active Training Time, ATT) | Weekly during the intervention period (up to 18 weeks) | 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. | ClinicalTrials.gov |
| Primary | Feasibility and satisfaction with the HDHI program (Program Feasibility and Satisfaction Questionnaire) | At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Fugl-Meyer Assessment - Upper Extremity (FMA-UE) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Action Research Arm Test (ARAT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Extended Barthel Index (eBI) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Functional Independence Measure (FIM) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Modified Rankin Scale (mRS) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Grip Strength - Hand Dynamometry | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Mini Balance Evaluation Systems Test (Mini-BESTest) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | 10-Meter Walk Test (10mWT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | 6-Minute Walk Test (6MWT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Timed Up and Go test (TUG) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Secondary | Five Times Sit-to-Stand test (5xSTS) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Other | Patient Global Impression of Change (PGIC) | At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion | 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. | ClinicalTrials.gov |
| Other | Pain Visual Analog Scale (VAS) | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
| Other | EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
| Other | PROMIS Global-10 | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
| Other | Short Form Stroke Impact Scale (SF-SIS) | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
| Other | Falls and sleep-related outcomes (modified questionnaire) | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
| Other | Behavioral Risk Factor Surveillance System (BRFSS) items | From baseline to follow-up assessments up to 12 months post-discharge | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Other outcome | ConductCognition |
| Corsi Block-Tapping Test | Other outcome | ConductCognition |
| Design Fluency Test | Other outcome | ConductCognition |
| Digit Span Test | Other outcome | ConductCognition |
| Go/No-Go Task | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)