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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000026031 |
Receipt No. | R000029922 |
Scientific Title | Development of a new assessment tool for promoting upper limb functional ability in patients with stoke |
Date of disclosure of the study information | 2017/02/07 |
Last modified on | 2019/03/11 |
Basic information | ||
Public title | Development of a new assessment tool for promoting upper limb functional ability in patients with stoke | |
Acronym | A new assessment tool for promoting upper limb functional ability in patients with stoke | |
Scientific Title | Development of a new assessment tool for promoting upper limb functional ability in patients with stoke | |
Scientific Title:Acronym | A new assessment tool for promoting upper limb functional ability in patients with stoke | |
Region |
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Condition | ||
Condition | Stroke | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the reliability, validity, and utility of a new assessment tool |
Basic objectives2 | Others |
Basic objectives -Others | To examine the reliability, validity, and utility of a new assessment tool |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Results of a new assessment tool (time required and score for each task in the assessment) |
Key secondary outcomes | Assessments of impairments and activity for the upper limb paresis |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Evaluation of upper limb functional ability with a new assessment tool | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | [Patients]
1. Patients with first-ever hemiparetic stroke 2. Able to understand the study purpose and method 3. Able to sit, stand, and walk with or without functional aids including orthosis 4. Consent to participate in the study [Healthy individuals] 1. No neurological and musculoskeletal impairments that limit the activities of daily tasks 2. Consent to participate in the study |
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Key exclusion criteria | [Patients]
1. Difficulties in using the upper limbs due to pain 2. Apparent motor impairments in the unaffected upper limb 3. Contraindications of exercises [Healthy individuals] 1. Pain in the upper limbs 2. Contraindications of exercises |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Keio University School of Medicine | ||||||
Division name | Department of Rehabilitation Medicine | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan | ||||||
TEL | 03-5363-3833 | ||||||
michiyukikawakami@hotmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Keio University School of Medicine | ||||||
Division name | Department of Rehabilitation Medicine | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan | ||||||
TEL | 03-5363-3833 | ||||||
Homepage URL | |||||||
otaka119@keio.jp |
Sponsor | |
Institute | Keio University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | National Institute of Information and Communications Technology |
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 | |
Address | |
Tel | |
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 |
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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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029922 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |