Trial results for a pilot study investigating Cognitive Stimulation Therapy for pre-frail Stroke survivors were posted on ClinicalTrials.gov on 2025-12-03, indicating that 4 stroke survivors and 4 carers were included in the framework analysis for acceptability.
Background
Frailty is described as a type of vulnerability where individuals may struggle to fully recover from stressors, such as illness or environmental changes. This condition is associated with negative health outcomes and an increased risk of early death, particularly in individuals who have experienced a stroke. Frailty was defined by Fried et al. (2001) based on the presence of at least three out of five clinical indicators: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. The concept of 'intermediate frailty status' is also recognized. Addressing frailty in stroke survivors is crucial for improving recovery and long-term health outcomes.
Trial design
This completed pilot study, identified as Phase NA, enrolled 10 participants. The trial focused on individuals with Stroke, Frailty, and also involved Carers. The intervention explored was Cognitive Stimulation Therapy, aimed at pre-frail stroke survivors. The study's primary focus, as indicated by the key measurements, was a framework analysis using the Theoretical Framework of Acceptability as a guiding framework.
Key results
Key measurements for the framework analysis using the Theoretical Framework of Acceptability as a guiding framework included:
- For Stroke Survivors, the count of participants was reported as 4 participants in several instances, and as 3 participants in one instance.
- For Carers, the count of participants was consistently reported as 4 participants.
What this means
The posted results from this pilot study provide initial data on the acceptability of Cognitive Stimulation Therapy for pre-frail stroke survivors and their carers. With 4 stroke survivors and 4 carers consistently included in the framework analysis, alongside one instance of 3 stroke survivors, the findings contribute to understanding the practical implementation and perceived value of such an intervention. As a pilot, these results help inform the design of larger studies, particularly concerning the engagement of both stroke survivors and their caregivers in therapeutic programs aimed at addressing frailty and cognitive well-being post-stroke.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors" were posted on 2025-12-03 on clinicaltrials.gov.