UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046396 |
|---|---|
| Receipt number | R000052934 |
| Scientific Title | Randomized controlled open trial of additional repetitive sit-to-stand exercises for acquiring sit to stand movements in patients with severe stroke |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2024/05/20 16:49:40 |
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Basic information
Public title
Randomized controlled open trial of additional repetitive sit-to-stand exercises for acquiring sit to stand movements in patients with severe stroke
Acronym
Randomized controlled open trial of additional repetitive sit-to-stand exercises for acquiring sit to stand movements in patients with severe stroke
Scientific Title
Randomized controlled open trial of additional repetitive sit-to-stand exercises for acquiring sit to stand movements in patients with severe stroke
Scientific Title:Acronym
Randomized controlled open trial of additional repetitive sit-to-stand exercises for acquiring sit to stand movements in patients with severe stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of repetitive sit-to-stand exercises add to standard rehabilitation in severe stroke patients who cannot sit-to-stand alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Probability of acquiring sit-to-stand movements
Key secondary outcomes
Time to acquire sit-to-stand movements,Incident of falling, Pain, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to 6-9 units of physical therapy, occupational therapy, and speech therapy per day, sit-to-stand training with assistance from the seating surface of 130% of the lower leg length.
Interventions/Control_2
6-9 units of physiotherapy, occupational therapy, speech therapy per day.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Diagnosis of cerebral infarction or cerebral hemorrhage.
2 40 to 90 years old.
3 sufficient communication skills to indicate yes/no verbally or via gestures.
4 Difficulty standing alone from the seating surface of 130% of the length of the lower leg even with handrails and lower limb orthotics.
5 FIM is 40 points or less.
6 Written consent has been obtained from the subject or family.
Key exclusion criteria
1 A history of stroke.
2 Complicated with locomotor disorders that interfere with sit-to-stand training.
3 Judging by the principal investigator or the attending physician that it is inappropriate from the viewpoint of safety.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shijima |
Organization
Saku Central Hospital
Division name
Department of Rehabilitation
Zip code
384-0301
Address
Usuda197,Saku,Nagano,Japan
TEL
0267-82-3131
rigaku@sakuhp.or.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shijima |
Organization
Saku Central Hospital
Division name
Department of Rehabilitation
Zip code
384-0301
Address
Usuda197,Saku, Nagano,Japan
TEL
0267-82-3131
Homepage URL
rigaku@sakuhp.or.jp
Sponsor or person
Institute
Saku 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
Saku Central Hospital Group Research Ethics Committee
Address
Usuda197, Saku, Nagano 384-0301 Japan
Tel
0267-82-3131
irboffice@sakuhp.or.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
佐久総合病院(長野県) Saku Central Hospital(Nagano)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 24 | 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
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052934
