Trial · NCT04134416
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Western Aphasia Battery (WAB) | Each participant will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess major clinical aspects of language function: information content, fluency, auditory comprehension, repetition and naming. Changes from Baseline in Western Aphasia Battery scores at 8, 10 and 26 weeks. Minimum and maximum values: 0-100 points. Higher scores mean better outcome. |
| Primary | Communicative Activity Log (CAL) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess communicative behavior in the everyday life of patients. Changes from Baseline in CAL scores at 8, 10 and 26 weeks. Minimum and maximum values: 0-90 points (0-40 points for quality of communication; 0-40 points for amount of communication). Higher values mean better outcome. |
| Primary | Stroke Aphasia Depression Questionnaire (SADQ-10) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess depressive symptomatology in persons with post-stroke aphasia. Changes from Baseline in SADQ-10 scores at 8, 10 and 26 weeks. Minimum and maximum scores: 1-30 points. Lower values mean better outcome. |
| Primary | Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess Quality of Life in persons with post-stroke aphasia. Changes from Baseline in SAQOL-39 scores at 8, 10 and 26 weeks. Minimum and maximum scores: 1-85 (Physical scale); 1-35 (Communication scale); 1-55 (Psychosocial scale); 1-20 (Vitality scale); 1-5 (Total mean scale). Higher values mean better outcome. |
| Secondary | Mini Mental State Examination (MMSE) | Each participant will be evaluated at week 0 (baseline). | To assess cognitive impairment in persons with post-stroke aphasia. Minimum and maximum scores: 1-30 points. Higher values mean better outcome. |
| Secondary | Trail-Making Test, parts A & B (TMT) | Each participant will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess executive functions in individuals affected by post-stroke aphasia. Changes from Baseline in TMT scores at 8, 10 and 26 weeks. The participant has to finish both parts as quickly as possible, with the time taken to complete the test being used as the primary performance metric. Lower completion time means better outcome. |
| Secondary | Digit Span Test from the Wechsler Adult Intelligence Scale (WAIS) | Each participant will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess immediate memory in persons with post-stroke aphasia. Changes from Baseline in Digit scores at 8, 10 and 26 weeks. Minimum and maximum scores: 3-9. Higher values mean better outcome. |
| Secondary | Attention Network Test (ANT). | Each participant will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess three attentional networks: alerting, orienting, and executive control in in persons with post-stroke aphasia. Changes from Baseline in ANT scores at 8, 10 and 26 weeks. Efficiency of the alerting network is examined by changes in Reaction Time (RT) resulting from a warning signal. Efficiency of orienting is examined by changes in RT that accompany cues indicating where the target will occur. The efficiency of the executive network is examined by requiring the subject to respond by pressing two keys indicating the direction (left or right) of a central arrow surrounded by congruent, incongruent or neutral flankers. Lower reaction time and higher congruent responses mean better outcome. |
| Secondary | Raven´s Colored Progressive Matrices (RPM), set A, B & AB | Each participant will be evaluated at week 0 (baseline). | To assess abstract reasoning in persons with post-stroke aphasia. Evaluation at baseline. Minimum and maximum score: 0-36. Higher scores mean better outcome. |
| Secondary | Cognitive Reserve Questionnaire. | Each participant will be evaluated at week 0 (baseline) | To assess the cognitive reserve of persons with post-stroke aphasia. Evaluation at baseline. Minimum and maximum scores: 0-25. Higher values mean better outcome. |
| Secondary | Hospital Anxiety and Depression Scale (HADS). | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess depressive and anxious symptomatology in persons with post-stroke aphasia. Changes from Baseline in HADS scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-21 points (Anxiety scale); 0-21 points (Depression scale). Lower values mean better outcome. |
| Secondary | Visual Dynamic Analogue Scale (D-VAMS). | Each participant will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess mood in persons with post-stroke aphasia. Changes from Baseline in D-VAMS scores at 8, 10 and 26 weeks. Minimum and maximum score: 0-100 points. Higher values mean better outcome. |
| Secondary | Neuropsychiatric Inventory (NPI). | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess neuropsychiatric symptomatology in persons with post-stroke aphasia. Changes from Baseline in NPI scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-12 points for each subscale. Score obtained by multiplying frequency\*severity scores. No total score available. Lower values mean better outcome. |
| Secondary | Starkstein Apathy Scale (SAS). | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess apathy in persons with post-stroke aphasia. Changes from Baseline in SAS scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-42 points. Lower values mean better outcome. |
| Secondary | Catastrophic Reaction Scale (CRS) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess catastrophic reactions in persons with post-stroke aphasia. Changes from Baseline in CRS scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-33 points. Lower values mean better outcome. |
| Secondary | Neurobehavioral Change after Aphasia Scale (experimental test). | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess personality changes in persons with post-stroke. Changes from Baseline scores at 8, 10 and 26 weeks. Minimum and maximum scores: 1-7 points for each subscale. Higher values mean better outcome. |
| Secondary | Barthel Index (IB) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess functional independence in persons with post-stroke aphasia. Changes from Baseline in functional independence scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-100 points. Higher values mean better outcome. |
| Secondary | Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To rule out dementia in persons with post-stroke aphasia. Changes from Baseline in functional independence scores at 8, 10 and 26 weeks. Minimum and maximum scores: 26-130 points. Lower values mean better outcome. |
| Secondary | Visual-analogue test assessing anosognosia for language impairment (VATA-L) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26 | To screen for anosognosia for aphasia in persons with post-stroke aphasia. Changes from Baseline in anosognosia scores at 8,10 and 26 weeks. Minimum and maximum scores: 0-42. Lower values mean better outcome. |
| Secondary | Communicative Effectiveness Index (CETI) | Each participant/ main carer will be evaluated at week 0 (baseline), 8, 10 and 26. | To assess functional communication in persons with post-stroke aphasia. Changes from Baseline in functional communication scores at 8, 10 and 26 weeks. Minimum and maximum scores: 0-100. Higher values mean better outcome. |
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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