UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048825 |
|---|---|
| Receipt number | R000055611 |
| Scientific Title | A Study of the Effect of Upper Limb Functional Training with Goal Setting by Aid for Decision-Making in Occupation Choice for Hand on the Amount of Use and Motor Function of the Upper Limb of the Paralyzed Side |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2026/06/30 09:32:38 |
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Basic information
Public title
Investigation of the Effectiveness of Upper Extremity Functional Training with Goal Setting by Aid for Decision-Making in Occupation Choice for Hand
Acronym
Effect of upper limb function training with ADOC-H
Scientific Title
A Study of the Effect of Upper Limb Functional Training with Goal Setting by Aid for Decision-Making in Occupation Choice for Hand on the Amount of Use and Motor Function of the Upper Limb of the Paralyzed Side
Scientific Title:Acronym
Effect of upper limb function training with ADOC-H
Region
| Japan |
Condition
Condition
cerebral infarction, cerebral hemorrhage
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine whether the intervention combining goal-setting for upper limb use in daily life using the ADOC-H, monitoring and problem-solving in addition to regular upper limb function training and ADL training increases the amount of use of the paralyzed upper limb in daily life in general, and whether it increases scores of motor function of the paralyzed upper limb using international evaluation indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor Activity Log
Fugl-Meyer Assessment (Upper Extremity Motor)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention that goal setting of upper limb use in daily life by Aid for Decision-making in Occupation Choice for Hand(ADOC-H), monitoring and problem-solving technique in addition to conventional occupational therapy.
Goal setting: The occupational therapist conducts an interview using the ADOC-H within 7 days of admission and decides with the patient on the activities to be performed with the paralyzed upper limb in daily living situations. The decided items are printed on paper and placed on the subject's bedside table so that the patient can check them at any time. When the patient is able to use the paralyzed upper limb in the selected situation and the occupational therapist determines that the patient is able to use the upper limb in other situations, another interview using the ADOC-H is conducted and the content is updated.
Monitoring: The occupational therapist monitors the patient's ability to use the paralytic upper extremity in the areas determined by the ADOC-H at each intervention. Problem-solving: We discuss with the patient how to use the paralytic upper limb, and encourage use of the paralytic upper limb by providing advice, introducing self-help devices, and making environmental adjustments as needed.
Interventions/Control_2
The data pool (Tokuda et al, 2020) is used as the control group about Fugl-Meyer Assessment (Upper Extremity Motor).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who have been admitted to Ina Central Hospital and have been diagnosed with stroke (cerebral infarction, cerebral hemorrhage).
Key exclusion criteria
1)Patients with limited range of motion of the upper limbs and weakness in the history before the onset of stroke.
2)Patients with cognitive decline with a Mini-Mental State Examination of less than 24 points
3)Patients who have difficulty communicating with ADOC-H due to impaired consciousness or higher brain dysfunction
4)Patients who could not provide informed consent
5)Patients who scored 0 points on either the knee-mouth test or the finger test of the SIAS paralyzed upper limb movement item at the time of admission, or patients who scored 5 points on both items.
6)Patients with recurrent stroke during hospitalization
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Ikegami |
Organization
Ina Central Hospital
Division name
Department of Rehabilitation
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano
TEL
0265-72-3121
masakk0208@gmail.com
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Ikegami |
Organization
Ina Central Hospital
Division name
Department of Rehabilitation
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano
TEL
0265-72-3121
Homepage URL
reha@inahp.jp
Sponsor or person
Institute
Ina Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Ina Central Hospital
Address
1313-1 Koshiroukubo, Ina, Nagano
Tel
0265-72-3121
reha@inahp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
22-13
Org. issuing International ID_1
Shinshu university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊那中央病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.11596/asiajot.22.65
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.11596/asiajot.22.65
Number of participants that the trial has enrolled
13
Results
The initial target sample size was 12, but this was changed to 15 after approval from the ethics review committee during the registration period. The final number of enrolled participants was 13. Compared with the control group from the data pool, the FMA-UE scores in the study group showed significant improvement, with changes that exceeded the MCID. Additionally, MAL scores improved significantly at discharge compared with admission, with the QOM score surpassing the MCID.
Results date posted
| 2026 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients in the study group were adults aged 20 years or older, admitted to our hospital between September 2022 and March 2023, with a diagnosis of stroke (either cerebral infarction or cerebral hemorrhage) and who provided consent to participate. Exclusion criteria included transient ischemic attacks; a prior history of restricted joint range of motion or muscle weakness in the paralyzed upper limb; inability to use the MAL because of impaired consciousness or severe aphasia; lack of consent; recurrent stroke during hospitalization; death during hospitalization (including those who passed away after consenting); and complete paralysis or no paralysis upon admission. The control group was derived from a data pool compiled by Tokuda et al. in 2020, which included patients diagnosed with stroke (cerebral infarction or cerebral hemorrhage). From 271 eligible patients, the control group was selected using propensity matching. Exclusion criteria for this group included altered consciousness, significant higher brain dysfunction, cerebellar lesions, stroke recurrence, and short hospital stays (under 14 days).
Participant flow
The study group initially comprised 13 patients who provided consent. After variable ratio matching, data of 12 participants in this group were analyzed. Similarly, in the control group, 51 of 271 individuals from the database were analyzed after variable ratio matching.
Adverse events
No adverse events were reported.
Outcome measures
FMA-UE at admission, 2 weeks after onset, and at discharge
MAL at admission and discharge
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055611
