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 |
Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Japan |
neurologic intractable disease
Neurology | Rehabilitation medicine |
Others
NO
Development of the arms sprint using the elbow joint manufactured with the 3D printer
Safety,Efficacy
Activities of daily living
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Other |
Development of the arms sprint using the elbow joint manufactured with the 3D printer
18 | years-old | <= |
100 | years-old | >= |
Male and Female
Patient whose daily living behavior is restricted due to upper limb tremor and ataxia.
Patient who can not obtain consent of this research participation.
3
1st name | Wakana |
Middle name | |
Last name | Togami |
Kunmamoto University Hospital
Physical Medicine and Rehabilitation
860-0556
1-1-1 Honjo Chuo-ku Kumamoto-city
096-373-5226
wakana.desu@kuh.kumamoto-u.ac.jp
1st name | Wakana |
Middle name | |
Last name | Togami |
Kunmamoto University Hospital
Physical Medicine and Rehabilitation
8608556
1-1-1 Honjo Chuo-ku Kumamoto-city
096-373-5226
wakana.desu@kuh.kumamoto-u.ac.jp
Kunmamoto University Hospital
None
Other
Kunmamoto University Hospital
1-1-1 Honjo Chuo-ku Kumamoto-city
096-373-5226
wakana.desu@kuh.kumamoto-u.ac.jp
NO
2019 | Year | 01 | Month | 04 | Day |
none
Unpublished
none
11
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
2021 | Year | 07 | Month | 06 | Day |
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.
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.
Nothing special
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.
Completed
2018 | Year | 12 | Month | 20 | Day |
2018 | Year | 12 | Month | 20 | Day |
2018 | Year | 12 | Month | 20 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 12 | Month | 28 | Day |
2021 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038499
Research Plan | |
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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 |