UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035388
Receipt number R000038499
Scientific Title Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Date of disclosure of the study information 2019/01/04
Last modified on 2021/07/12 15:13:44

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Basic information

Public title

Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.

Acronym

Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.

Scientific Title

Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.

Scientific Title:Acronym

Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.

Region

Japan


Condition

Condition

neurologic intractable disease

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of the arms sprint using the elbow joint manufactured with the 3D printer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Activities of daily living

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Other

Interventions/Control_1

Development of the arms sprint using the elbow joint manufactured with the 3D printer

Interventions/Control_2


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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient whose daily living behavior is restricted due to upper limb tremor and ataxia.

Key exclusion criteria

Patient who can not obtain consent of this research participation.

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Wakana
Middle name
Last name Togami

Organization

Kunmamoto University Hospital

Division name

Physical Medicine and Rehabilitation

Zip code

860-0556

Address

1-1-1 Honjo Chuo-ku Kumamoto-city

TEL

096-373-5226

Email

wakana.desu@kuh.kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Wakana
Middle name
Last name Togami

Organization

Kunmamoto University Hospital

Division name

Physical Medicine and Rehabilitation

Zip code

8608556

Address

1-1-1 Honjo Chuo-ku Kumamoto-city

TEL

096-373-5226

Homepage URL


Email

wakana.desu@kuh.kumamoto-u.ac.jp


Sponsor or person

Institute

Kunmamoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kunmamoto University Hospital

Address

1-1-1 Honjo Chuo-ku Kumamoto-city

Tel

096-373-5226

Email

wakana.desu@kuh.kumamoto-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 04 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

11

Results

Barthel Idex: 100 points
-Functional Independence Measure (FIM): 123
Upper limb function evaluation:
Twenty Holes Pegboad; 6 right), 5 left)
STEF; right) 64 points, left) 78 points
Motor Activity Log
AOU 3.9, QOM : 4.0
Canada work performance evaluation;
Performance score: 5.2, Satisfaction score: 6.2
Archimedes Spiral Task: Right <Left scale 2/4

Results date posted

2021 Year 07 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with restrictions on activities of daily living due to upper limb tremor or ataxia

The subjects are about 3 patients / year who meet the following selection criteria.
Selection criteria
Patients whose activities of daily living are restricted due to tremor of the upper limbs or ataxia.
Age: No matter
Gender: No matter
Patients who can obtain written consent to participate in this study from the patient and his / her substitute.
Exclusion criteria
Patients who have skin fragility and cannot wear sprints.
Patients who do not consent to participate in this study.

Participant flow

For patients with restrictions on activities of daily living due to upper limb tremor, ataxia, etc., we attached an upper limb sprint using an elbow joint made with a 3D printer developed by us, and before and after wearing it.
Barthel Index (BI; functional evaluation of activities of daily living)
Functional Independence Measure (FIM)
Upper limb function evaluation (peg operation: upper limb dexterity task, etc.)
Motor Activity Log (MAL; Upper limb motor function evaluation method)
Canadian Occupational Performance Measure (COPM, patient subjective)
Evaluation of activities of daily living)
Archimedes spiral task (Evaluation of tremor: Evaluation of tremor by having the patient describe the whirlpool on the paper I do. )
To evaluate.

Adverse events

Nothing special

Outcome measures

Before and after wearing the upper limb sprint using an elbow joint made with a 3D printer
Barthel Index (BI; functional evaluation of activities of daily living)
Functional Independence Measure (FIM)
Upper limb function evaluation (peg operation: upper limb dexterity task, etc.)
Motor Activity Log (MAL; Upper limb motor function evaluation method)
-Canadian Occupational Performance Measure (COPM, patient subjective)
Evaluation of activities of daily living)
Archimedes spiral task (Evaluation of tremor: Evaluation of tremor by having the patient describe the whirlpool on the paper
I do. )

Cancellation criteria
When skin damage that requires medical treatment occurs in the area where the sprint comes into contact.
If the research is stopped, only the information obtained up to that point will be analyzed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 20 Day

Date of IRB

2018 Year 12 Month 20 Day

Anticipated trial start date

2018 Year 12 Month 20 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 28 Day

Last modified on

2021 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038499


Research Plan
Registered date File name
2021/06/30 研究計画書 【最終版】手関節スプリント+中西教授追加分02_02 (1) - 1.docx

Research case data specifications
Registered date File name
2021/06/30 同意書及び同意撤回書【最終版】手関節追加分.docx

Research case data
Registered date File name
2021/06/30 02 振戦1(仮)未承認医薬品 報告様式.docx