Trial · NCT07913763
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Six-Minute Walk Test (6MWT) | Baseline to end of follow-up (day 135) | The 6MWT assesses walking capacity by measuring the distance walked in six minutes, expressed in meters. The primary endpoint is the percentage change in walking distance from baseline to the end of follow-up on day 135. Greater distances indicate better walking capacity. |
| Secondary | Six-Minute Walk Test (6MWT) -EOT | Baseline to end of treatment (day 90) | The 6MWT assesses walking capacity by measuring the distance walked in six minutes, expressed in meters. The percentage change in walking distance from baseline to the end of treatment at day 90. Greater distances indicate better walking capacity. |
| Secondary | Borg CR10 Scale | Baseline to end of follow-up (day 135) | The Borg CR10 Scale assesses perceived exertion after the 6MWT. Scores range from 0 (no exertion) to 10 (maximal exertion). Higher scores indicate greater perceived exertion. |
| Secondary | 6MWT Clinically Relevant Improvement | Baseline to end of follow-up (day 135) | The number of participants achieving a clinically relevant improvement in walking distance, defined as an increase of more than 40 meters or more than 25% compared with baseline. |
| Secondary | Ten-Meter Walk Test (10MWT) | Baseline to end of follow-up (day 135) | The Ten-Meter Walk Test (10MWT) assesses walking performance by measuring the time required to walk 10 meters at a comfortable or maximal pace. Shorter completion times indicate faster walking performance. Walking speed over 10 meters is reported in meters/second. |
| Secondary | Multidimensional Fatigue Inventory (MFI-20) | Baseline to end of follow-up (day 135) | The MFI-20 assesses fatigue across five dimensions using 20 items. The total score ranges from 20 to 100, with higher scores indicating greater fatigue. |
| Secondary | Fatigue Severity Scale (FSS) | Baseline to end of follow-up (day 135) | The FSS assesses the impact of fatigue on daily functioning. It contains nine items scored from 1 to 7. The mean score is calculated, with higher scores indicating greater fatigue severity. |
| Secondary | Stroke Impact Scale (SIS 3.0) | Baseline to end of follow-up (day 135) | The SIS 3.0 assesses the impact of stroke on health and daily functioning across multiple domains. Domain scores range from 0 to 100, with higher scores indicating better functioning or fewer limitations. |
| Secondary | Five-level EuroQol five-dimension questionnaire (EQ-5D-5L) | Baseline and end of follow-up (day 135) | The EQ-5D-5L assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a health utility index using an appropriate value set. |
| Secondary | Patient Global Impression of Change (PGIC) | End of treatment (day 90) and End of follow-up (day 135). | The PGIC assesses the participant's overall perception of change in their condition. Scores range from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. |
| Secondary | Adverse Events (AEs) | Baseline and end of follow-up (day 135) | Number of participants experiencing at least one adverse event (AE). Adverse events will be recorded and assessed by severity, causality, and type. |
| Secondary | Serious Adverse Events (SAEs) | Baseline and end of follow-up (day 135) | Number of participants experiencing at least one serious adverse event (SAE) during the study. |
| Secondary | Adverse Events of Special Interest (AESIs) | Baseline and end of follow-up (day 135) | Number of participants experiencing at least one protocol-defined adverse event of special interest. Particular attention is given to psychiatric events and clinically relevant changes in mental status because of the known psychiatric risk profile of rimonabant. |
| Secondary | Beck Depression Inventory-II (BDI-II) | Baseline and end of follow-up (day 135) | The Beck Depression Inventory-II (BDI-II) assesses depressive symptoms. Higher scores indicate greater depressive symptom severity. According to the protocol, a score ≥20 triggers clinical evaluation by the investigator. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Baseline and end of follow-up (day 135) | The Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression symptoms. Higher scores indicate greater symptom severity. According to the protocol, a score ≥11 on either subscale (anxiety or depression) triggers clinical evaluation by the investigator. |
| Secondary | The Visual Analogue Scale for Pain (VAS-P) | Baseline and end of follow-up (day 135) | Assesses the participant's subjective perception of pain intensity. Changes from baseline will be used to identify clinically significant changes in pain during treatment and follow-up. |
| Secondary | Spasticity Assessed by Modified Ashworth Scale (MAS) | Baseline and end of follow-up (day 135) | The MAS assesses resistance to passive movement as a measure of muscle spasticity. Scores range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), including an intermediate category of 1+. Higher scores indicate greater spasticity. |
| Secondary | Penn Spasm Frequency Scale (PSFS) | Baseline and end of follow-up (day 135) | The PSFS assesses muscle spasm frequency. Scores range from 0 (no spasms) to 4 (spasms occurring more than ten times per hour). Higher scores indicate more frequent spasms. |
| Secondary | Number of Falls | Baseline and end of follow-up (day 135) | Mean number of falls during the previous 30 days, based on weekly records in the participant diary and collected at each follow-up visit. |
| Secondary | Daily Standing Activity | Baseline and end of follow-up (day 135) | Mean percentage of daily time spent standing during the previous 30 days, based on daily records in the participant diary and collected at each follow-up visit to provide contextual information when evaluating changes in the number of falls. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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