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A Study Investigating the Effectiveness of Lifestyle-Oriented Rehabilitation in Patients with Acute Stroke Requiring Assistance in Daily Activities

Effectiveness of the Management Tool for Daily Life Performance in Acute Stroke Patients Requiring Assistance with Daily Activities: A Pilot Single-Blind Randomized Controlled Trial - MTDLP Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058133
Enrollment
23
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Occupational therapy will be provided in accordance with the Stroke Treatment Guidelines, and the intervention will additionally follow the procedures for implementing the MTDLP in the acute phase.

Sponsors

Akiyama Neurosurgical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria Patients with a first-ever stroke. Patients within one month of stroke onset. Requiring assistance in ADL, defined as having a score of 5 or lower (supervision or setup assistance) in at least one FIM motor item excluding stair climbing and cognitive items.

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded Individuals with higher brain dysfunction or dementia that impairs comprehension of instructions. Patients who have been under physician ordered bed rest restrictions preventing mobilization for four or more consecutive days after admission. Individuals requiring assistance with ADL prior to admission, defined as a pre stroke modified Rankin Scale score of 4 or higher. Patients exhibiting recurrent stroke or neurological deterioration at the time of enrollment. Patients with an unknown onset date.

Design outcomes

Primary

MeasureTime frame
Intervention completion rate,Participant enrollment and dropout rate,Functional Independence Measure (FIM) The intervention completion rate, participant enrollment rates, and dropout rate will be calculated after the completion of the recruitment period. The FIM will be assessed at baseline and at discharge.

Secondary

MeasureTime frame
Inpatient length of stay,Discharge disposition,EuroQol 5-dimensions 5-levels(EQ-5D-5L) Inpatient length of stay and discharge disposition will be calculated after the completion of the recruitment period. The EQ-5D-5L will be assessed at baseline and at discharge.

Countries

Japan

Contacts

Public ContactTatsuya Iwasaki

Akiyama Neurosurgical Hospital Department of Rehabilitation

62514501.xrx@kuhs.ac.jp0458461001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026