UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053225 |
|---|---|
| Receipt number | R000056010 |
| Scientific Title | The effect of intensive inpatient rehabilitation after botulinum toxin type A administration for patients with chronic motor paralysis after stroke |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/08/05 20:06:19 |
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Basic information
Public title
The effect of intensive inpatient rehabilitation after botulinum toxin type A administration for patients with chronic motor paralysis after stroke
Acronym
The effect of intensive inpatient rehabilitation after botulinum toxin type A administration
Scientific Title
The effect of intensive inpatient rehabilitation after botulinum toxin type A administration for patients with chronic motor paralysis after stroke
Scientific Title:Acronym
The effect of intensive inpatient rehabilitation after botulinum toxin type A administration
Region
| Japan |
Condition
Condition
patient with chronic motor paralysis after stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the amount and content of intensive inpatient rehabilitation after botulinum toxin type A administration for chronic motor paralysis after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Modified Ashworth Scale measured 4 and 8 weeks after administration of botulinum toxin type A
Key secondary outcomes
Global Rating of Change scale, Fugl-Meyer Assessment, Action Research Arm Test, Box and Block Test, Motor Activity Log, 10m walk test, Euro Qol-5D
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1) Botulinum toxin A (BoNT-A) therapy
Total dosage 400 units or less
2) Intensive rehabilitation
Intensive rehabilitation will be performed daily, 120 minutes/day for 28 days. The program's contents are KINVIS therapy (20 minutes) and individual rehabilitation (100 minutes).
Interventions/Control_2
1) Botulinum toxin A (BoNT-A) therapy
Total dosage 400 units or less
2) Intensive rehabilitation
Intensive rehabilitation will be performed daily, 120 minutes/day for 28 days. The program's content is individual rehabilitation (120 minutes).
Interventions/Control_3
1) Botulinum toxin A (BoNT-A) therapy
Total dosage 400 units or less
2) Intensive rehabilitation
Intensive rehabilitation will be performed daily, 120 minutes/day for 56 days. The program's contents are KINVIS therapy (20 minutes) and individual rehabilitation (100 minutes).
Interventions/Control_4
1) Botulinum toxin A (BoNT-A) therapy
Total dosage 400 units or less
2) Intensive rehabilitation
Intensive rehabilitation will be performed daily, 120 minutes/day for 56 days. The program's content is individual rehabilitation (120 minutes).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in the chronic phase of stroke who are visiting our outpatient clinic and whose Modified Ashworth Scale (MAS) score of the target spastic muscle is between 1+ (mild hypertonia with resistance less than 1/2 the range of motion) and less than 4 (affected area is rigid and difficult to flex and extend), without significant cognitive dysfunction (Mini-Mental State Examination; MSE 24 points or higher).
Key exclusion criteria
Patients treated for spasticity with oral muscle relaxants, motor point block with phenol, intrathecal baclofen pump therapy within the last three months
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Maruyama |
Organization
Shonan-Keiiku Hospital
Division name
Department of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa city, Kanagawa pref., Japan
TEL
0466480050
s-maruyama@keiiku.gr.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Maruyama |
Organization
Shonan-Keiiku Hospital
Division name
Department of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa city, Kanagawa pref., Japan
TEL
0466480050
Homepage URL
s-maruyama@keiiku.gr.jp
Sponsor or person
Institute
Department of Rehabilitation, Shonan-Keiiku Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation, Shonan-Keiiku Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan-Keiiku Hospital
Address
4360 Endo, Fujisawa city, Kanagawa pref., Japan
Tel
0466480050
s-maruyama@keiiku.gr.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
| 2024 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056010
