Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060454) titled 'A Study to Evaluate the Effects of the Rehabilitation Goal-Setting Support System (e-ASUHS) in Patients With Acute Stroke' on Feb. 12.

Study Type: Interventional

Study Design: Basic Design - n-of-1 Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Akiyama Neurosurgical Hospital

Condition: Condition - Stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to examine the effects of an intervention using the electronic version of the Activities Specific Upper-Extremity Hemiparesis Scale (e-ASUHS) on depressive symptoms, quality of life (QOL), and upper-extremity function in patients with acute stroke. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - To enhance external validity and generalizability, the data collection period was set to 14 days, during which a baseline phase (A phase) and an intervention phase (B phase) were allocated based on the average length of stay for acute stroke in Japan (ischemic stroke 16 days, intracerebral hemorrhage 20 days, Stroke Data Bank 2025). Both phases lasted at least 2 days (Fujimaki et al. 2022). The intervention was provided once daily, 5 days per week, for 40 to 60 minutes per session by the principal investigator.

A multiple baseline single case design with randomized phase allocation was used. Following Fujimaki et al. (2022), three baseline patterns were applied across participants: 1 AAAABBBBBBBBBB, 2 AAAAAAAABBBBBB, 3 AAAAABBBBBBBBB.

During the baseline phase (A phase), goal setting based on Omori et al. (2018) and task oriented training described by Geller et al. (2023) were implemented. Task oriented training involved repetitive practice of functional tasks to improve activities of daily living (ADL) and upper extremity function.

During the intervention phase (B phase), procedures followed Matsuoka et al. (2021). The electronic version of the Activities Specific Upper extremity Hemiparesis Scale (e ASUHS) is an Excel based goal setting support system that facilitates selection of ADL tasks according to upper extremity function (Matsuoka et al. 2023). Participant information and upper extremity function including the Fugl Meyer Assessment for the Upper Extremity (FMA UE) were entered, achievable tasks were automatically highlighted to support shared decision making, task oriented training was conducted, and progress was monitored using a checklist.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Participants were required to meet all of the following inclusion criteria.

1 Patients diagnosed with stroke at Akiyama Neurosurgical Hospital.

2 Within 1 month of stroke onset YS An CS et al. 2021.

3 Aged 18 years or older regardless of sex.

4 Presence of upper extremity paresis.

5 Presence of depressive symptoms defined as a Patient Health Questionnaire 9 PHQ 9 score of 5 or higher. Key exclusion criteria - Participants were excluded if they met any of the following criteria.

Difficulty following instructed tasks due to cognitive impairment higher brain dysfunction or impaired consciousness.

Inability to maintain a sitting position for 30 minutes or longer including wheelchair sitting.

Presence of severe pain in the upper extremity.

Inability to make clear decisions.

Unknown date of stroke onset.

No history of psychiatric disorders. Target Size - 3

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 08 Day Date of IRB - 2026 Year 02 Month 12 Day Anticipated trial start date - 2026 Year 02 Month 13 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069171

Disclaimer: Curated by HT Syndication.