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 2023/04/27 04:28:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


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

2023 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name