Tokyo, June 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062068) titled 'Development of a new system (e-ASUHS) to support the setting of goals for daily activities performed with the affected upper extremity after stroke' on June 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kanagawa University of Human Services

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

Objective: Narrative objectives1 - The aims of this study are to provide information necessary for shared decision-making with patients regarding the paretic upper extremity in stroke rehabilitation, to develop a prediction model generalizable across multiple centers using the goal-setting support system e-ASUHS, and to investigate the association between an intervention that facilitates shared decision-making and psychological outcomes. Ultimately, this study seeks to contribute to occupational therapy practice that incorporates shared decision-making for patients with stroke and to enhance their quality of life (QOL). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - e-ASUHS group: e-ASUHS will be introduced to patients with a wide range of paretic upper extremity function. Participants who consent to receive rehabilitation using e-ASUHS will undergo an e-ASUHS-based intervention, while the remainder of their rehabilitation will be the same as that provided to the control group. In the acute phase, goal setting using e-ASUHS will be conducted once a week, whereas in the convalescent, home-visit, day-care, and outpatient rehabilitation settings, it will be conducted once a month. Participants will also be encouraged to practice the daily activities selected as goals in their everyday lives. The intervention period will be from admission to discharge in the acute and convalescent rehabilitation settings, and 6 months in the home-visit, day-care, and outpatient rehabilitation settings. Interventions/Control_2 - Control group: Participants will be assigned to the control group if consent to use e-ASUHS is not obtained, or if the occupational therapist judges that the use of e-ASUHS would be difficult in consideration of the therapeutic relationship with the participant. The control group will receive usual rehabilitation. The intervention period will be from admission to discharge in the acute and convalescent rehabilitation settings, and 6 months in the home-visit, day-care, and outpatient rehabilitation settings.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - The inclusion criteria were as follows: (1) patients with upper extremity hemiparesis due to a first-ever cerebral infarction or intracerebral hemorrhage, and (2) patients who provided written informed consent to participate in this study. Key exclusion criteria - The exclusion criteria were as follows: (1) severe cognitive impairment that made it difficult to follow instructions; (2) inability to maintain a sitting position for more than 30 minutes; (3) severe upper extremity pain; and (4) inability to make decisions clearly regarding participation in the study. Target Size - 660

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2023 Year 09 Month 11 Day Date of IRB - 2023 Year 09 Month 11 Day Anticipated trial start date - 2023 Year 09 Month 11 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058286

Disclaimer: Curated by HT Syndication.