UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051067 |
|---|---|
| Receipt number | R000058231 |
| Scientific Title | Combined repetitive facilitative exercise and task-oriented training for hemiplegic upper extremity during convalescent phase after stroke: before-and-after feasibility trial |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/15 23:18:55 |
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Basic information
Public title
Combined repetitive facilitative exercise and task-oriented training for hemiplegic upper extremity during convalescent phase after stroke: before-and-after feasibility trial
Acronym
Task-oriented repetitive facilitative exercise
Scientific Title
Combined repetitive facilitative exercise and task-oriented training for hemiplegic upper extremity during convalescent phase after stroke: before-and-after feasibility trial
Scientific Title:Acronym
Task-oriented repetitive facilitative exercise
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility in training with task-oriented repetitive facilitative exercise for upper limb paralysis after stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Action Research Arm Test
Motor Activity Log
Aid for Decision-making in Occupation Choice
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Task-oriented repetitive facilitative exercise
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) New single stroke within 28-60 days of onset
2) Ability to pick up and drop one sheet of tissue paper
3) Stable sitting position
4) Brunnstrom recovery stage more than 3 in the upper extremity
5) Clinically stable medical state.
Key exclusion criteria
1) Shoulder pain
2) Severe cognitive dysfunction that would interfere with understanding instructions from the doctor or therapist
3) Contraindication for electrical stimulation, such as a pacemaker implant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koya |
| Middle name | |
| Last name | Fujimoto |
Organization
Kirishima sugiyasu Hospital
Division name
Rehabilitation
Zip code
8994201
Address
Kirishimataguchi 2143, Kirishima City, Kagoshima
TEL
0995-57-1221
koya.0416.fjmt@gmail.com
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Fujimoto |
Organization
Kirishima Sugiyasu Hospital
Division name
Rehabilitation
Zip code
8994201
Address
Kirishimataguchi 2143, Kirishima City, Kagoshima
TEL
0995-57-1221
Homepage URL
koya.0416.fjmt@gmail.com
Sponsor or person
Institute
Kirishima Sugiyasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Kirishim Sugiyasu Hospital
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
Kirishima Sugiyasu Hospital
Address
Kirishimataguchi 2143, kirishima-city, Kagoshima
Tel
0995-57-1221
koya.0416.fjmt@gmail.com
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
| 2023 | Year | 05 | Month | 15 | 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
8
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
| 2000 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058231
