Trial results for an early phase 1 study investigating a new tool to enhance post-stroke upper extremity disability were posted on ClinicalTrials.gov on 2025-06-25, with 21 participants enrolled.
Background
Stroke is a leading cause of long-term disability, often significantly impacting upper extremity function. Individuals with low socioeconomic status (SES) are particularly vulnerable, experiencing higher rates of disability at three months post-stroke and facing challenges in adhering to physician guidelines. These challenges stem from increased disability making patients ineligible or unable to tolerate therapy, and poor access to quality care, such as lack of transportation. Addressing these disparities requires the development of novel tools that enhance therapy accessibility.
Trial design
This completed early phase 1 study enrolled 21 participants with Stroke. The trial investigated a novel tool aimed at enhancing post-stroke upper extremity disability, comparing a 'START' intervention group against a 'Control' group. The study sought to explore initial feasibility and effects on various measures of upper extremity function.
Key results
The trial reported several key measurements related to upper extremity function:
- Change in Action Research Arm Test (ARAT) Total Score From Baseline to Post-Intervention (Units on a scale):
- Control group: Mean of 0.72 (Standard Deviation 1.737292)
- START group: Mean of 0 (Standard Deviation 2.692582)
- Retention in Action Research Arm Test (ARAT) (Units on a scale):
- Control group: Mean of 1 (Standard Deviation 1.603567)
- START group: Mean of -0.666667 (Standard Deviation 3.204164)
- Change in Motor Activity Log (MAL) Amount of Use Score From Baseline to Post-Intervention (units on scale):
- Control group: Mean of -2.045455 (Standard Deviation 12.02384)
- START group: Mean of 0.388889 (Standard Deviation 5.085382)
- Retention in Motor Activity Log (MAL) (units on scale):
- Control group: Mean of 5.0625 (Standard Deviation 8.174164)
- START group: Mean of 12.75 (Standard Deviation 21.731889)
- Change in Upper Extremity Fugl Meyer (UEFM) Baseline to Post-intervention (units on a scale):
- Control group: Mean of 0.090909 (Standard Deviation 3.935849)
- START group: Mean of 1.555556 (Standard Deviation 3.574602)
- Retention of Upper Extremity Fugl Meyer From End Training to One-month Post (units on a scale):
- Control group: Mean of -0.5 (Standard Deviation 5.291503)
- START group: Mean of -0.333333 (Standard Deviation 5.715476)
What this means
The posted results from this early phase 1 study provide initial data on the impact of the investigated tool on post-stroke upper extremity function. While the 'START' group showed a higher mean change in Upper Extremity Fugl Meyer (UEFM) score from baseline to post-intervention compared to the control group, other measures like the Action Research Arm Test (ARAT) change score were higher in the control group. Conversely, the 'START' group demonstrated a higher mean retention in Motor Activity Log (MAL) scores. Given the small enrollment of 21 participants and the early phase of the study, these findings are preliminary and suggest areas for further investigation into the potential benefits and mechanisms of the intervention for stroke rehabilitation, particularly in making therapy more accessible.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05277389, titled 'New Tool to Enhance Post-stroke Upper Extremity Disability', were posted on 2025-06-25 on clinicaltrials.gov.